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extacy
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sadismed
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scaged
scager
scages
scaging
scagly
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scantily
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scantilyer
scantilyes
scantilying
scantilyly
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schlonged
schlonger
schlonges
schlonging
schlongly
schlongs
scrog
scroged
scroger
scroges
scroging
scrogly
scrogs
scrot
scrote
scroted
scroteed
scroteer
scrotees
scroteing
scrotely
scroter
scrotes
scroting
scrotly
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scrotum
scrotumed
scrotumer
scrotumes
scrotuming
scrotumly
scrotums
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scruded
scruder
scrudes
scruding
scrudly
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scumed
scumer
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scuming
scumly
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seamaner
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seamaning
seamanly
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seamener
seamenes
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seamenly
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seduceer
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seduceing
seducely
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semened
semener
semenes
semening
semenly
semens
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shamedameed
shamedameer
shamedamees
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shamedamely
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shit
shite
shiteater
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shiteaterer
shiteateres
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shiteaterly
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shiteed
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shitees
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shitely
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shites
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shitfacely
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shitheader
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shithousely
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shitly
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shitted
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shitteres
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shitterly
shitters
shittes
shitting
shittly
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shittyes
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shittyly
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shized
shizer
shizes
shizing
shizly
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shooted
shooter
shootes
shooting
shootly
shoots
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sissyed
sissyer
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sissying
sissyly
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skaged
skager
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skaging
skagly
skags
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skanked
skanker
skankes
skanking
skankly
skanks
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slaveed
slaveer
slavees
slaveing
slavely
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slutsing
slutsly
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smegmaed
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sodomed
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sodomly
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spiced
spicer
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spick
spicked
spicker
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spickly
spicks
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spics
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spoof
spoofed
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spoofly
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spoogeed
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spoogees
spoogeing
spoogely
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spunked
spunker
spunkes
spunking
spunkly
spunks
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steamyer
steamyes
steamying
steamyly
steamys
stfu
stfued
stfuer
stfues
stfuing
stfuly
stfus
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stiffyed
stiffyer
stiffyes
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stiffyly
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stonedes
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stonedly
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stupider
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stupidly
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suckes
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suckinger
suckinges
suckinging
suckingly
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suckly
sucks
sumofabiatch
sumofabiatched
sumofabiatcher
sumofabiatches
sumofabiatching
sumofabiatchly
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tarded
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tardes
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tardly
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tawdryes
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tawdryly
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teabagginged
teabagginger
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teabaggingly
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terd
terded
terder
terdes
terding
terdly
terds
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testee
testeed
testeeed
testeeer
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testeely
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testees
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testely
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testeser
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testesly
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testicle
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testiclely
testicles
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testised
testiser
testises
testising
testisly
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thruster
thrustes
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thrustly
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thuged
thuger
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thugly
thugs
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tinkleed
tinkleer
tinklees
tinkleing
tinklely
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tit
tited
titer
tites
titfuck
titfucked
titfucker
titfuckes
titfucking
titfuckly
titfucks
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titied
titier
tities
titiing
titily
titing
titis
titly
tits
titsed
titser
titses
titsing
titsly
titss
tittiefucker
tittiefuckered
tittiefuckerer
tittiefuckeres
tittiefuckering
tittiefuckerly
tittiefuckers
titties
tittiesed
tittieser
tittieses
tittiesing
tittiesly
tittiess
titty
tittyed
tittyer
tittyes
tittyfuck
tittyfucked
tittyfucker
tittyfuckered
tittyfuckerer
tittyfuckeres
tittyfuckering
tittyfuckerly
tittyfuckers
tittyfuckes
tittyfucking
tittyfuckly
tittyfucks
tittying
tittyly
tittys
toke
tokeed
tokeer
tokees
tokeing
tokely
tokes
toots
tootsed
tootser
tootses
tootsing
tootsly
tootss
tramp
tramped
tramper
trampes
tramping
tramply
tramps
transsexualed
transsexualer
transsexuales
transsexualing
transsexually
transsexuals
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trashyed
trashyer
trashyes
trashying
trashyly
trashys
tubgirl
tubgirled
tubgirler
tubgirles
tubgirling
tubgirlly
tubgirls
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turded
turder
turdes
turding
turdly
turds
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tushed
tusher
tushes
tushing
tushly
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twater
twates
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twatly
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twatser
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uzied
uzier
uzies
uziing
uzily
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vaged
vager
vages
vaging
vagly
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valiumed
valiumer
valiumes
valiuming
valiumly
valiums
venous
virgined
virginer
virgines
virgining
virginly
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vixen
vixened
vixener
vixenes
vixening
vixenly
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vodkaer
vodkaes
vodkaing
vodkaly
vodkas
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voyeured
voyeurer
voyeures
voyeuring
voyeurly
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vulgared
vulgarer
vulgares
vulgaring
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wang
wanged
wanger
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wanging
wangly
wangs
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wanked
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wankerer
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wankerly
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wankly
wanks
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wazooed
wazooer
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wazooing
wazooly
wazoos
wedgie
wedgieed
wedgieer
wedgiees
wedgieing
wedgiely
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weeder
weedes
weeding
weedly
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weenieed
weenieer
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weenieing
weeniely
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weewee
weeweeed
weeweeer
weeweees
weeweeing
weeweely
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weiner
weinered
weinerer
weineres
weinering
weinerly
weiners
weirdo
weirdoed
weirdoer
weirdoes
weirdoing
weirdoly
weirdos
wench
wenched
wencher
wenches
wenching
wenchly
wenchs
wetback
wetbacked
wetbacker
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wetbacking
wetbackly
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whitey
whiteyed
whiteyer
whiteyes
whiteying
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whized
whizer
whizes
whizing
whizly
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whoralicioused
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whoraliciousing
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whore
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whorealicioused
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whorealiciously
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whoreded
whoreder
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whoredly
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whorees
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whorefaceed
whorefaceer
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whorefaceing
whorefacely
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whorehopper
whorehoppered
whorehopperer
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whorehoppering
whorehopperly
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whorehouse
whorehouseed
whorehouseer
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whorehouseing
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whoreing
whorely
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whoresed
whoreser
whoreses
whoresing
whoresly
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whoringer
whoringes
whoringing
whoringly
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wigger
wiggered
wiggerer
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wiggerly
wiggers
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woodyed
woodyer
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woodying
woodyly
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wop
woped
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woping
woply
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wtf
wtfed
wtfer
wtfes
wtfing
wtfly
wtfs
xxx
xxxed
xxxer
xxxes
xxxing
xxxly
xxxs
yeasty
yeastyed
yeastyer
yeastyes
yeastying
yeastyly
yeastys
yobbo
yobboed
yobboer
yobboes
yobboing
yobboly
yobbos
zoophile
zoophileed
zoophileer
zoophilees
zoophileing
zoophilely
zoophiles
anal
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ass lick
balls
ballsac
bisexual
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cheap
cost of miracles
cunt
display network stats
fart
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feom
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humira AND expensive
illegal
madvocate
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texarkana
effective for the treatment of a baby
effective for the treatment of a boy
effective for the treatment of a child
effective for the treatment of a female
effective for the treatment of a girl
effective for the treatment of a kid
effective for the treatment of a minor
effective for the treatment of a newborn
effective for the treatment of a teen
effective for the treatment of a teenager
effective for the treatment of a toddler
effective for the treatment of a woman
effective for the treatment of adolescents
effective for the treatment of an adolescent
effective for the treatment of an infant
effective for the treatment of babies
effective for the treatment of baby
effective for the treatment of body building
effective for the treatment of boys
effective for the treatment of breast feeding
effective for the treatment of children
effective for the treatment of females
effective for the treatment of fetus
effective for the treatment of girls
effective for the treatment of infants
effective for the treatment of kids
effective for the treatment of minors
effective for the treatment of newborn
effective for the treatment of pediatric
effective for the treatment of pregnancy
effective for the treatment of pregnant
effective for the treatment of teenagers
effective for the treatment of teens
effective for the treatment of toddlers
effective for the treatment of women
effective for the treatment of youths
for the relief of a baby
for the relief of a boy
for the relief of a child
for the relief of a female
for the relief of a girl
for the relief of a kid
for the relief of a minor
for the relief of a newborn
for the relief of a teen
for the relief of a teenager
for the relief of a toddler
for the relief of a woman
for the relief of adolescents
for the relief of an adolescent
for the relief of an infant
for the relief of babies
for the relief of baby
for the relief of body building
for the relief of boys
for the relief of breast feeding
for the relief of children
for the relief of females
for the relief of fetus
for the relief of girls
for the relief of infants
for the relief of kids
for the relief of minors
for the relief of newborn
for the relief of pediatric
for the relief of pregnancy
for the relief of pregnant
for the relief of teenagers
for the relief of teens
for the relief of toddlers
for the relief of women
for the relief of youths
medicating a baby
medicating a boy
medicating a child
medicating a female
medicating a girl
medicating a kid
medicating a minor
medicating a newborn
medicating a teen
medicating a teenager
medicating a toddler
medicating a woman
medicating adolescents
medicating an adolescent
medicating an infant
medicating babies
medicating baby
medicating body building
medicating boys
medicating breast feeding
medicating children
medicating females
medicating fetus
medicating girls
medicating infants
medicating kids
medicating minors
medicating newborn
medicating pediatric
medicating pregnancy
medicating pregnant
medicating teenagers
medicating teens
medicating toddlers
medicating women
medicating youths
at risk for a baby
at risk for a boy
at risk for a child
at risk for a female
at risk for a girl
at risk for a kid
at risk for a minor
at risk for a newborn
at risk for a teen
at risk for a teenager
at risk for a toddler
at risk for a woman
at risk for adolescents
at risk for an adolescent
at risk for an infant
at risk for babies
at risk for baby
at risk for body building
at risk for boys
at risk for breast feeding
at risk for children
at risk for females
at risk for fetus
at risk for girls
at risk for infants
at risk for kids
at risk for minors
at risk for newborn
at risk for pediatric
at risk for pregnancy
at risk for pregnant
at risk for teenagers
at risk for teens
at risk for toddlers
at risk for women
at risk for youths
treating a baby
treating a boy
treating a child
treating a female
treating a girl
treating a kid
treating a minor
treating a newborn
treating a teen
treating a teenager
treating a toddler
treating a woman
treating adolescents
treating an adolescent
treating an infant
treating babies
treating baby
treating body building
treating boys
treating breast feeding
treating children
treating females
treating fetus
treating girls
treating infants
treating kids
treating minors
treating newborn
treating pediatric
treating pregnancy
treating pregnant
treating teenagers
treating teens
treating toddlers
treating women
treating youths
treatment for a baby
treatment for a boy
treatment for a child
treatment for a female
treatment for a girl
treatment for a kid
treatment for a minor
treatment for a newborn
treatment for a teen
treatment for a teenager
treatment for a toddler
treatment for a woman
treatment for adolescents
treatment for an adolescent
treatment for an infant
treatment for babies
treatment for baby
treatment for body building
treatment for boys
treatment for breast feeding
treatment for children
treatment for females
treatment for fetus
treatment for girls
treatment for infants
treatment for kids
treatment for minors
treatment for newborn
treatment for pediatric
treatment for pregnancy
treatment for pregnant
treatment for teenagers
treatment for teens
treatment for toddlers
treatment for women
treatment for youths
treatments for a baby
treatments for a boy
treatments for a child
treatments for a female
treatments for a girl
treatments for a kid
treatments for a minor
treatments for a newborn
treatments for a teen
treatments for a teenager
treatments for a toddler
treatments for a woman
treatments for adolescents
treatments for an adolescent
treatments for an infant
treatments for babies
treatments for baby
treatments for body building
treatments for boys
treatments for breast feeding
treatments for children
treatments for females
treatments for fetus
treatments for girls
treatments for infants
treatments for kids
treatments for minors
treatments for newborn
treatments for pediatric
treatments for pregnancy
treatments for pregnant
treatments for teenagers
treatments for teens
treatments for toddlers
treatments for women
treatments for youths
diagnosing a baby
diagnosing a boy
diagnosing a child
diagnosing a female
diagnosing a girl
diagnosing a kid
diagnosing a minor
diagnosing a newborn
diagnosing a teen
diagnosing a teenager
diagnosing a toddler
diagnosing a woman
diagnosing adolescents
diagnosing an adolescent
diagnosing an infant
diagnosing babies
diagnosing baby
diagnosing body building
diagnosing boys
diagnosing breast feeding
diagnosing children
diagnosing females
diagnosing fetus
diagnosing girls
diagnosing infants
diagnosing kids
diagnosing minors
diagnosing newborn
diagnosing pediatric
diagnosing pregnancy
diagnosing pregnant
diagnosing teenagers
diagnosing teens
diagnosing toddlers
diagnosing women
diagnosing youths
indicated for a baby
indicated for a boy
indicated for a child
indicated for a female
indicated for a girl
indicated for a kid
indicated for a minor
indicated for a newborn
indicated for a teen
indicated for a teenager
indicated for a toddler
indicated for a woman
indicated for adolescents
indicated for an adolescent
indicated for an infant
indicated for babies
indicated for baby
indicated for body building
indicated for boys
indicated for breast feeding
indicated for children
indicated for females
indicated for fetus
indicated for girls
indicated for infants
indicated for kids
indicated for minors
indicated for newborn
indicated for pediatric
indicated for pregnancy
indicated for pregnant
indicated for teenagers
indicated for teens
indicated for toddlers
indicated for women
indicated for youths
useful for a baby
useful for a boy
useful for a child
useful for a female
useful for a girl
useful for a kid
useful for a minor
useful for a newborn
useful for a teen
useful for a teenager
useful for a toddler
useful for a woman
useful for adolescents
useful for an adolescent
useful for an infant
useful for babies
useful for baby
useful for body building
useful for boys
useful for breast feeding
useful for children
useful for females
useful for fetus
useful for girls
useful for infants
useful for kids
useful for minors
useful for newborn
useful for pediatric
useful for pregnancy
useful for pregnant
useful for teenagers
useful for teens
useful for toddlers
useful for women
useful for youths
effective for a baby
effective for a boy
effective for a child
effective for a female
effective for a girl
effective for a kid
effective for a minor
effective for a newborn
effective for a teen
effective for a teenager
effective for a toddler
effective for a woman
effective for adolescents
effective for an adolescent
effective for an infant
effective for babies
effective for baby
effective for body building
effective for boys
effective for breast feeding
effective for children
effective for females
effective for fetus
effective for girls
effective for infants
effective for kids
effective for minors
effective for newborn
effective for pediatric
effective for pregnancy
effective for pregnant
effective for teenagers
effective for teens
effective for toddlers
effective for women
effective for youths
cures for a baby
cures for a boy
cures for a child
cures for a female
cures for a girl
cures for a kid
cures for a minor
cures for a newborn
cures for a teen
cures for a teenager
cures for a toddler
cures for a woman
cures for adolescents
cures for an adolescent
cures for an infant
cures for babies
cures for baby
cures for body building
cures for boys
cures for breast feeding
cures for children
cures for females
cures for fetus
cures for girls
cures for infants
cures for kids
cures for minors
cures for newborn
cures for pediatric
cures for pregnancy
cures for pregnant
cures for teenagers
cures for teens
cures for toddlers
cures for women
cures for youths
use in a baby
use in a boy
use in a child
use in a female
use in a girl
use in a kid
use in a minor
use in a newborn
use in a teen
use in a teenager
use in a toddler
use in a woman
use in adolescents
use in an adolescent
use in an infant
use in babies
use in baby
use in body building
use in boys
use in breast feeding
use in children
use in females
use in fetus
use in girls
use in infants
use in kids
use in minors
use in newborn
use in pediatric
use in pregnancy
use in pregnant
use in teenagers
use in teens
use in toddlers
use in women
use in youths
use in patients with a baby
use in patients with a boy
use in patients with a child
use in patients with a female
use in patients with a girl
use in patients with a kid
use in patients with a minor
use in patients with a newborn
use in patients with a teen
use in patients with a teenager
use in patients with a toddler
use in patients with a woman
use in patients with adolescents
use in patients with an adolescent
use in patients with an infant
use in patients with babies
use in patients with baby
use in patients with body building
use in patients with boys
use in patients with breast feeding
use in patients with children
use in patients with females
use in patients with fetus
use in patients with girls
use in patients with infants
use in patients with kids
use in patients with minors
use in patients with newborn
use in patients with pediatric
use in patients with pregnancy
use in patients with pregnant
use in patients with teenagers
use in patients with teens
use in patients with toddlers
use in patients with women
use in patients with youths
a baby diagnosis
a boy diagnosis
a child diagnosis
a female diagnosis
a girl diagnosis
a kid diagnosis
a minor diagnosis
a newborn diagnosis
a teen diagnosis
a teenager diagnosis
a toddler diagnosis
a woman diagnosis
adolescents diagnosis
an adolescent diagnosis
an infant diagnosis
babies diagnosis
baby diagnosis
body building diagnosis
boys diagnosis
breast feeding diagnosis
children diagnosis
females diagnosis
fetus diagnosis
girls diagnosis
infants diagnosis
kids diagnosis
minors diagnosis
newborn diagnosis
pediatric diagnosis
pregnancy diagnosis
pregnant diagnosis
teenagers diagnosis
teens diagnosis
toddlers diagnosis
women diagnosis
youths diagnosis
a baby medication
a boy medication
a child medication
a female medication
a girl medication
a kid medication
a minor medication
a newborn medication
a teen medication
a teenager medication
a toddler medication
a woman medication
adolescents medication
an adolescent medication
an infant medication
babies medication
baby medication
body building medication
boys medication
breast feeding medication
children medication
females medication
fetus medication
girls medication
infants medication
kids medication
minors medication
newborn medication
pediatric medication
pregnancy medication
pregnant medication
teenagers medication
teens medication
toddlers medication
women medication
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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
In a move that acknowledges the gauntlet the US health system poses for people facing serious and fatal illnesses, Medicare will pay for a new class of workers to help patients manage treatments for conditions like cancer and heart failure.
The 2024 Medicare physician fee schedule includes new billing codes, including G0023, to pay for 60 minutes a month of care coordination by certified or trained auxiliary personnel working under the direction of a clinician.
A diagnosis of cancer or another serious illness takes a toll beyond the physical effects of the disease. Patients often scramble to make adjustments in family and work schedules to manage treatment, said Samyukta Mullangi, MD, MBA, medical director of oncology at Thyme Care, a Nashville, Tennessee–based firm that provides navigation and coordination services to oncology practices and insurers.
“It just really does create a bit of a pressure cooker for patients,” Dr. Mullangi told this news organization.
Medicare has for many years paid for medical professionals to help patients cope with the complexities of disease, such as chronic care management (CCM) provided by physicians, nurses, and physician assistants.
The new principal illness navigation (PIN) payments are intended to pay for work that to date typically has been done by people without medical degrees, including those involved in peer support networks and community health programs. The US Centers for Medicare and Medicaid Services(CMS) expects these navigators will undergo training and work under the supervision of clinicians.
The new navigators may coordinate care transitions between medical settings, follow up with patients after emergency department (ED) visits, or communicate with skilled nursing facilities regarding the psychosocial needs and functional deficits of a patient, among other functions.
CMS expects the new navigators may:
- Conduct assessments to understand a patient’s life story, strengths, needs, goals, preferences, and desired outcomes, including understanding cultural and linguistic factors.
- Provide support to accomplish the clinician’s treatment plan.
- Coordinate the receipt of needed services from healthcare facilities, home- and community-based service providers, and caregivers.
Peers as Navigators
The new navigators can be former patients who have undergone similar treatments for serious diseases, CMS said. This approach sets the new program apart from other care management services Medicare already covers, program officials wrote in the 2024 physician fee schedule.
“For some conditions, patients are best able to engage with the healthcare system and access care if they have assistance from a single, dedicated individual who has ‘lived experience,’ ” according to the rule.
The agency has taken a broad initial approach in defining what kinds of illnesses a patient may have to qualify for services. Patients must have a serious condition that is expected to last at least 3 months, such as cancer, heart failure, or substance use disorder.
But those without a definitive diagnosis may also qualify to receive navigator services.
In the rule, CMS cited a case in which a CT scan identified a suspicious mass in a patient’s colon. A clinician might decide this person would benefit from navigation services due to the potential risks for an undiagnosed illness.
“Regardless of the definitive diagnosis of the mass, presence of a colonic mass for that patient may be a serious high-risk condition that could, for example, cause obstruction and lead the patient to present to the emergency department, as well as be potentially indicative of an underlying life-threatening illness such as colon cancer,” CMS wrote in the rule.
Navigators often start their work when cancer patients are screened and guide them through initial diagnosis, potential surgery, radiation, or chemotherapy, said Sharon Gentry, MSN, RN, a former nurse navigator who is now the editor in chief of the Journal of the Academy of Oncology Nurse & Patient Navigators.
The navigators are meant to be a trusted and continual presence for patients, who otherwise might be left to start anew in finding help at each phase of care.
The navigators “see the whole picture. They see the whole journey the patient takes, from pre-diagnosis all the way through diagnosis care out through survival,” Ms. Gentry said.
Gaining a special Medicare payment for these kinds of services will elevate this work, she said.
Many newer drugs can target specific mechanisms and proteins of cancer. Often, oncology treatment involves testing to find out if mutations are allowing the cancer cells to evade a patient’s immune system.
Checking these biomarkers takes time, however. Patients sometimes become frustrated because they are anxious to begin treatment. Patients may receive inaccurate information from friends or family who went through treatment previously. Navigators can provide knowledge on the current state of care for a patient’s disease, helping them better manage anxieties.
“You have to explain to them that things have changed since the guy you drink coffee with was diagnosed with cancer, and there may be a drug that could target that,” Ms. Gentry said.
Potential Challenges
Initial uptake of the new PIN codes may be slow going, however, as clinicians and health systems may already use well-established codes. These include CCM and principal care management services, which may pay higher rates, Mullangi said.
“There might be sensitivity around not wanting to cannibalize existing programs with a new program,” Dr. Mullangi said.
In addition, many patients will have a copay for the services of principal illness navigators, Dr. Mullangi said.
While many patients have additional insurance that would cover the service, not all do. People with traditional Medicare coverage can sometimes pay 20% of the cost of some medical services.
“I think that may give patients pause, particularly if they’re already feeling the financial burden of a cancer treatment journey,” Dr. Mullangi said.
Pay rates for PIN services involve calculations of regional price differences, which are posted publicly by CMS, and potential added fees for services provided by hospital-affiliated organizations.
Consider payments for code G0023, covering 60 minutes of principal navigation services provided in a single month.
A set reimbursement for patients cared for in independent medical practices exists, with variation for local costs. Medicare’s non-facility price for G0023 would be $102.41 in some parts of Silicon Valley in California, including San Jose. In Arkansas, where costs are lower, reimbursement would be $73.14 for this same service.
Patients who get services covered by code G0023 in independent medical practices would have monthly copays of about $15-$20, depending on where they live.
The tab for patients tends to be higher for these same services if delivered through a medical practice owned by a hospital, as this would trigger the addition of facility fees to the payments made to cover the services. Facility fees are difficult for the public to ascertain before getting a treatment or service.
Dr. Mullangi and Ms. Gentry reported no relevant financial disclosures outside of their employers.
A version of this article first appeared on Medscape.com.
As GLP-1 Use Surges, Clinicians Weigh Benefits and Risks
Rates of overweight and obesity have more than doubled in the United States during the last three decades, according to a new analysis. By 2050, it’s anticipated that 213 million adults (age, > 25 years) and 43 million children and adolescents will have overweight or obesity. The results led authors of a study to describe obesity as having reached a “crisis point” requiring urgent action and interventions.
Are glucagon-like peptide 1 receptor agonists (GLP-1 RAs), originally developed and prescribed for diabetes and now approved for weight loss, the answer?
Their popularity is certainly surging. Between the last 6 months of 2022 vs the last 6 months of 2024, the number of patients prescribed GLP-1 RAs increased by 132.6%. This is also reflected in a shift in public awareness, with a recent survey of US adults finding that 32% of respondents had heard “a lot” about these drugs, up from 19% in 2023.
GLP-1 RAs (including tirzepatide, which targets not only the GLP-1 receptor but also the glucose-dependent insulinotropic polypeptide receptor) have shown efficacy in weight loss. A 2022 review and meta-analysis of 22 trials (17,183 patients) found that 50.2% and 17.5% of those treated with GLP-1 RAs had a ≥ 5% and ≥ 10% weight loss, respectively, compared with placebo. A 2023 review of 41 trials (15,135 patients) found that compared with controls, GLP-1 RAs significantly reduced body weight, body mass index, waist circumference, and waist-to-hip ratio.
“GLP-1 RAs are great medications,” Andres Acosta, MD, PhD, director of the Precision Medicine for Obesity Laboratory, Mayo Clinic, Rochester, Minnesota, told Medscape Medical News. “We’ve been using them for almost two decades. But now there’s excitement about their utility in treating obesity.”
Treating the Four Categories of Obesity
Daniel Drucker, MD, senior investigator at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada, is a pioneer in diabetes treatment and particularly in the development of GLP-1 RAs. Drucker told Medscape Medical News that despite the efficacy and enormous potential of GLP-1 RAs, “we know some people don’t lose much weight when taking these medicines and others don’t feel well and can’t take them.”
The number of individuals who don’t respond to or aren’t able to tolerate GLP-1 RAs “might be small — less than 10% of people who try to take them — but we don’t fully understand the differences in response across different individuals,” Drucker said.
Acosta agreed, adding that it’s “essential for us to identify who will be the best responders, as we do with medications for other conditions, such as cancer and cardiovascular disease.”
Acosta’s group has spent more than a decade engaged in efforts to identify unique characteristics among patients with obesity and has succeeded in identifying four obesity phenotypes.
“What matters in the space of GLP-1 is that using this classification, we can identify the best responders and those who don’t respond.”
The first phenotype, described as “Hungry Gut” (HG), includes patients with abnormal postprandial satiety. “Although they may be satiated at the end of a meal, they have accelerated gastric emptying and therefore feel hungry between meals and want to keep eating,” he said.
There are also patients who experience abnormal satiety during meals. According to Acosta, these are the patients who will return to the table for second and third helpings. “They don’t feel full and continue to eat more and more in a single sitting” — a phenomenon referred to as “Hungry Brain.”
The third phenotype — “Emotional Hunger” — consists of people who are “hedonic” about food or engage in emotional eating behavior, whereas in the fourth group, people have “an abnormal metabolism in which they don’t burn enough calories. They have an inefficient metabolic rate.” This latter phenomenon is called “Slow Burn.”
Acosta and colleagues randomized 312 patients attending a weight management center to phenotype-guided or non–phenotype-guided treatment with anti-obesity medications (phentermine, phentermine/topiramate, bupropion/naltrexone, lorcaserin, and liraglutide). The phenotype-guided approach was associated with a 1.75-fold greater weight loss after 1 year than the non–phenotype-guided approach (mean weight loss, 15.9% vs 9.0%, respectively).
GLP-1 RAs: Not One-Size-Fits-All
Acosta’s group has developed a genetic test that uses patients’ saliva to identify their obesity phenotype, with the aim of predicting the best responders to GLP-1 RAs. The test, MyPhenome genetic obesity test, is licensed by Acosta’s lab and available through Phenomix Sciences.
Acosta and colleagues presented their findings at the American Gastroenterological Association’s 2024 annual meeting regarding a machine-learning gene risk score (ML-GRS) they developed to predict HG, based on saliva and blood samples. Their genetic studies generated a ML-GRS that classified participants with obesity along a continuum from “HG Positive” (HG+) to “HG Negative” (HG−). Compared with the HG− participants, those who were HG+ had superior total body weight loss with semaglutide at 9 and 12 months. When used to predict response, the ML-GRS had an area under the curve of 0.76 (P = .04) and a positive predictive value of 0.95.
According to Acosta, HG+ patients are “the best responders to the GLP-1 RAs, although we don’t yet understand the mechanism of why they have the phenomenon of abnormal postprandial satiety. It may be an abnormal genetic pathway or abnormal secretion of GLP-1. More studies are needed.”
He noted that GLP-1 RAs “might also be helpful with the second [Hungry Brain] category, but these patients do better with phentermine-topiramate,” as demonstrated in a 2023 study conducted by Acosta and colleagues.
His group has also studied which lifestyle interventions are most effective for each phenotype. “When a unique lifestyle intervention targeting each phenotype was applied, patients lost more weight and had greater metabolic improvement,” he reported.
“Treating obesity no longer needs to be trial-and-error, but should be done using precision medicine because one size doesn’t fit all,” Acosta said.
Concerning Side Effects
The popular media has featured stories about individuals who took GLP-1 RAs for weight loss and experienced serious side effects, including a recent account of a British nurse who died after taking tirzepatide. As reported by the BBC, the nurse’s death certificate listed multiple organ failure, septic shock, and pancreatitis as the immediate causes of death, with the “use of prescribed tirzepatide” recorded as a contributing factor. The report went on to note that there were 23 suspected deaths in the United Kingdom tied to semaglutide since 2019.
Beyond brand-name products, there are also risks associated with GLP-1 RAs manufactured by compounding pharmacies. In early November, CNN reported that compounded semaglutide has been linked to at least 10 deaths. Because of a prior shortage of tirzepatide, the US Food and Drug Administration (FDA) had allowed compounding pharmacies to manufacture the drug. In October, the FDA clarified that it won’t take legal action against compounders, even now that the shortage has been resolved.
A pharmacovigilance study using the FDA Adverse Event Reporting System identified “potential safety signals of increased mortality and serious adverse event reporting” associated with certain GLP-1 RAs — especially in younger patients and women (P < .0001 for both groups).
The most common side effects reported with GLP-1 RAs are gastrointestinal events, such as nausea, diarrhea, constipation, and vomiting. Most occur during dose initiation and escalation and wane over the following weeks. However, studies have also reported severe side effects, including a higher risk for pancreatitis, bowel obstruction, and gastroparesis, as well as a significantly higher risk for gallbladder and biliary diseases. In fact, according to one study, patients with diabetes taking GLP-1 RAs reported gastrointestinal-related issues as a “prominent factor” in their decision to discontinue taking these medications.
Several types of cancer are potentially associated with GLP-1 RAs, but findings regarding this potential link have been inconsistent. In a recent review article, Drucker noted there were only inconsistent data linking GLP-1 RAs with thyroid cancer and medullary thyroid cancer and that their potential association with pancreatic has “not been supported by results from randomized controlled trials or real-world data.”
Concerns have been raised about loss of lean mass and muscle strength and function, especially in older individuals with obesity and advanced liver, cardiovascular, or kidney disease. However, as Drucker pointed out in his review article, muscle function may not correlate with the loss of lean mass. In fact, there are “consistent reductions” in lean mass after bariatric surgery, but “little evidence to date for impairment of muscle function.” He added that newer GLP-1 agents under development for obesity treatment are focusing on “developing complementary therapies that preferentially reduce adipose tissue, while sparing lean mass.”
As covered by Medscape Medical News, there have been reports of potential suicidal ideation associated with GLP-1 RAs. This triggered a 2023 review from the European Medicines Agency. However, recent results from a cohort study and a post hoc analysis of randomized controlled trials concluded that there is no evidence that these drugs increase suicidal ideation or behavior.
In early November, the FDA updated the labels for the GLP-1 RAs to include a warning regarding pulmonary aspiration during general anesthesia or deep sedation. Guidance from a group of societies, led by the American Society of Anesthesiologists, contains recommendations regarding nuances of addressing this concern in surgical patients taking these agents.
Not a Standalone Treatment
Marc-Andre Cornier, MD, professor of medicine, James A. Keating Endowed Chair in Diabetes, and director of the Division of Endocrinology, Diabetes and Metabolic Diseases, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, told Medscape Medical News that GLP-1 RAs should not be viewed as cosmetic interventions but rather as medical treatments, “not only for weight loss but to reverse obesity-associated complications.”
Moreover, they should be used “as an adjunct to lifestyle changes,” emphasized Cornier. “We want our patients to have a high-quality diet with high protein content, fluid, vitamins, and minerals, and we want them to exercise.” Especially with the concern of potential loss of muscle mass with these agents, “resistance exercise might help mitigate that concern.”
Recently published recommendations can assist clinicians in guiding patients taking GLP-1 RAs to optimize nutrition. The recommendations note that patients should be referred to a registered dietitian to “complement and support” treatment with anti-obesity medications.
What Do Patients Want?
Despite the ever-rising popularity of GLP-1 RAs, a new national survey of over 2200 US adults conducted by the Physicians Committee for Responsible Medicine suggests that most Americans don’t want to use them. Among those who wanted to lose weight, almost three-quarters “disagreed” or “strongly disagreed” with the idea of taking a weight-loss injectable, and 68% of those who wanted to lose weight “agreed” or “strongly agreed” that they would be willing to try a plant-based diet, if it could lead to significant weight loss.
Moreover, many individuals treated with GLP-1 RAs discontinue their use, despite the probability of regaining the weight, according to a report that found only 46.3% of GLP-1 users were still taking the medications at 6 months and only 32.3% at 1 year. The authors commented that their real-world findings show a “substantially lower” 1-year persistence rate, compared with the rate reported in clinical trials. They suggest that the financial burden (> $12,000/year) may contribute to discontinuation.
Discontinuation of GLP-1 RAs can lead to worsening cardiometabolic parameters, with a potential increased risk for adverse outcomes; moreover, weight cycling (“yo-yo dieting”) carries its own risks. In light of these concerns, it’s particularly important to select appropriate patients and to determine whether potential short-term therapy has any enduring benefit.
Acosta agreed. “It’s exciting when looking at the data on how to find the best responders and who should make the effort to take these medications — not only in terms of side effects but also in terms of cost and which patients will receive maximum benefits and should be covered by insurance.”
Drucker has served as a consultant or speaker for Altimmune, Amgen, AstraZeneca, Arrowhead, Boehringer Ingelheim, Kallyope, Merck Research Laboratories, Novo Nordisk, Pfizer, and Zealand Pharma. He holds nonexercised options in Kallyope. Mount Sinai Hospital receives research support for investigator-initiated studies in the Drucker laboratory from Amgen, Novo Nordisk, Pfizer, and Zealand Pharma. Gila Therapeutics and Phenomix Sciences have licensed Acosta’s research technologies from University of Florida and Mayo Clinic. Acosta received consultant fees in the last 5 years from Rhythm Pharmaceuticals, Gila Therapeutics, Amgen, General Mills, Regeneron Pharmaceuticals, Boehringer Ingelheim, Novo Nordisk, Currax, Nestlé, Phenomix Sciences, Bausch Health, and Rare Disease. He received funding support from the National Institutes of Health, Vivus Pharmaceuticals, Novo Nordisk, Apollo Endosurgery, Satiogen Pharmaceuticals, Spatz Medical, Rhythm Pharmaceuticals, Regeneron Pharmaceuticals, Boehringer Ingelheim, and Novo Nordisk. In the past, Cornier has served as a consultant for Novo Nordisk.
A version of this article first appeared on Medscape.com.
Rates of overweight and obesity have more than doubled in the United States during the last three decades, according to a new analysis. By 2050, it’s anticipated that 213 million adults (age, > 25 years) and 43 million children and adolescents will have overweight or obesity. The results led authors of a study to describe obesity as having reached a “crisis point” requiring urgent action and interventions.
Are glucagon-like peptide 1 receptor agonists (GLP-1 RAs), originally developed and prescribed for diabetes and now approved for weight loss, the answer?
Their popularity is certainly surging. Between the last 6 months of 2022 vs the last 6 months of 2024, the number of patients prescribed GLP-1 RAs increased by 132.6%. This is also reflected in a shift in public awareness, with a recent survey of US adults finding that 32% of respondents had heard “a lot” about these drugs, up from 19% in 2023.
GLP-1 RAs (including tirzepatide, which targets not only the GLP-1 receptor but also the glucose-dependent insulinotropic polypeptide receptor) have shown efficacy in weight loss. A 2022 review and meta-analysis of 22 trials (17,183 patients) found that 50.2% and 17.5% of those treated with GLP-1 RAs had a ≥ 5% and ≥ 10% weight loss, respectively, compared with placebo. A 2023 review of 41 trials (15,135 patients) found that compared with controls, GLP-1 RAs significantly reduced body weight, body mass index, waist circumference, and waist-to-hip ratio.
“GLP-1 RAs are great medications,” Andres Acosta, MD, PhD, director of the Precision Medicine for Obesity Laboratory, Mayo Clinic, Rochester, Minnesota, told Medscape Medical News. “We’ve been using them for almost two decades. But now there’s excitement about their utility in treating obesity.”
Treating the Four Categories of Obesity
Daniel Drucker, MD, senior investigator at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada, is a pioneer in diabetes treatment and particularly in the development of GLP-1 RAs. Drucker told Medscape Medical News that despite the efficacy and enormous potential of GLP-1 RAs, “we know some people don’t lose much weight when taking these medicines and others don’t feel well and can’t take them.”
The number of individuals who don’t respond to or aren’t able to tolerate GLP-1 RAs “might be small — less than 10% of people who try to take them — but we don’t fully understand the differences in response across different individuals,” Drucker said.
Acosta agreed, adding that it’s “essential for us to identify who will be the best responders, as we do with medications for other conditions, such as cancer and cardiovascular disease.”
Acosta’s group has spent more than a decade engaged in efforts to identify unique characteristics among patients with obesity and has succeeded in identifying four obesity phenotypes.
“What matters in the space of GLP-1 is that using this classification, we can identify the best responders and those who don’t respond.”
The first phenotype, described as “Hungry Gut” (HG), includes patients with abnormal postprandial satiety. “Although they may be satiated at the end of a meal, they have accelerated gastric emptying and therefore feel hungry between meals and want to keep eating,” he said.
There are also patients who experience abnormal satiety during meals. According to Acosta, these are the patients who will return to the table for second and third helpings. “They don’t feel full and continue to eat more and more in a single sitting” — a phenomenon referred to as “Hungry Brain.”
The third phenotype — “Emotional Hunger” — consists of people who are “hedonic” about food or engage in emotional eating behavior, whereas in the fourth group, people have “an abnormal metabolism in which they don’t burn enough calories. They have an inefficient metabolic rate.” This latter phenomenon is called “Slow Burn.”
Acosta and colleagues randomized 312 patients attending a weight management center to phenotype-guided or non–phenotype-guided treatment with anti-obesity medications (phentermine, phentermine/topiramate, bupropion/naltrexone, lorcaserin, and liraglutide). The phenotype-guided approach was associated with a 1.75-fold greater weight loss after 1 year than the non–phenotype-guided approach (mean weight loss, 15.9% vs 9.0%, respectively).
GLP-1 RAs: Not One-Size-Fits-All
Acosta’s group has developed a genetic test that uses patients’ saliva to identify their obesity phenotype, with the aim of predicting the best responders to GLP-1 RAs. The test, MyPhenome genetic obesity test, is licensed by Acosta’s lab and available through Phenomix Sciences.
Acosta and colleagues presented their findings at the American Gastroenterological Association’s 2024 annual meeting regarding a machine-learning gene risk score (ML-GRS) they developed to predict HG, based on saliva and blood samples. Their genetic studies generated a ML-GRS that classified participants with obesity along a continuum from “HG Positive” (HG+) to “HG Negative” (HG−). Compared with the HG− participants, those who were HG+ had superior total body weight loss with semaglutide at 9 and 12 months. When used to predict response, the ML-GRS had an area under the curve of 0.76 (P = .04) and a positive predictive value of 0.95.
According to Acosta, HG+ patients are “the best responders to the GLP-1 RAs, although we don’t yet understand the mechanism of why they have the phenomenon of abnormal postprandial satiety. It may be an abnormal genetic pathway or abnormal secretion of GLP-1. More studies are needed.”
He noted that GLP-1 RAs “might also be helpful with the second [Hungry Brain] category, but these patients do better with phentermine-topiramate,” as demonstrated in a 2023 study conducted by Acosta and colleagues.
His group has also studied which lifestyle interventions are most effective for each phenotype. “When a unique lifestyle intervention targeting each phenotype was applied, patients lost more weight and had greater metabolic improvement,” he reported.
“Treating obesity no longer needs to be trial-and-error, but should be done using precision medicine because one size doesn’t fit all,” Acosta said.
Concerning Side Effects
The popular media has featured stories about individuals who took GLP-1 RAs for weight loss and experienced serious side effects, including a recent account of a British nurse who died after taking tirzepatide. As reported by the BBC, the nurse’s death certificate listed multiple organ failure, septic shock, and pancreatitis as the immediate causes of death, with the “use of prescribed tirzepatide” recorded as a contributing factor. The report went on to note that there were 23 suspected deaths in the United Kingdom tied to semaglutide since 2019.
Beyond brand-name products, there are also risks associated with GLP-1 RAs manufactured by compounding pharmacies. In early November, CNN reported that compounded semaglutide has been linked to at least 10 deaths. Because of a prior shortage of tirzepatide, the US Food and Drug Administration (FDA) had allowed compounding pharmacies to manufacture the drug. In October, the FDA clarified that it won’t take legal action against compounders, even now that the shortage has been resolved.
A pharmacovigilance study using the FDA Adverse Event Reporting System identified “potential safety signals of increased mortality and serious adverse event reporting” associated with certain GLP-1 RAs — especially in younger patients and women (P < .0001 for both groups).
The most common side effects reported with GLP-1 RAs are gastrointestinal events, such as nausea, diarrhea, constipation, and vomiting. Most occur during dose initiation and escalation and wane over the following weeks. However, studies have also reported severe side effects, including a higher risk for pancreatitis, bowel obstruction, and gastroparesis, as well as a significantly higher risk for gallbladder and biliary diseases. In fact, according to one study, patients with diabetes taking GLP-1 RAs reported gastrointestinal-related issues as a “prominent factor” in their decision to discontinue taking these medications.
Several types of cancer are potentially associated with GLP-1 RAs, but findings regarding this potential link have been inconsistent. In a recent review article, Drucker noted there were only inconsistent data linking GLP-1 RAs with thyroid cancer and medullary thyroid cancer and that their potential association with pancreatic has “not been supported by results from randomized controlled trials or real-world data.”
Concerns have been raised about loss of lean mass and muscle strength and function, especially in older individuals with obesity and advanced liver, cardiovascular, or kidney disease. However, as Drucker pointed out in his review article, muscle function may not correlate with the loss of lean mass. In fact, there are “consistent reductions” in lean mass after bariatric surgery, but “little evidence to date for impairment of muscle function.” He added that newer GLP-1 agents under development for obesity treatment are focusing on “developing complementary therapies that preferentially reduce adipose tissue, while sparing lean mass.”
As covered by Medscape Medical News, there have been reports of potential suicidal ideation associated with GLP-1 RAs. This triggered a 2023 review from the European Medicines Agency. However, recent results from a cohort study and a post hoc analysis of randomized controlled trials concluded that there is no evidence that these drugs increase suicidal ideation or behavior.
In early November, the FDA updated the labels for the GLP-1 RAs to include a warning regarding pulmonary aspiration during general anesthesia or deep sedation. Guidance from a group of societies, led by the American Society of Anesthesiologists, contains recommendations regarding nuances of addressing this concern in surgical patients taking these agents.
Not a Standalone Treatment
Marc-Andre Cornier, MD, professor of medicine, James A. Keating Endowed Chair in Diabetes, and director of the Division of Endocrinology, Diabetes and Metabolic Diseases, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, told Medscape Medical News that GLP-1 RAs should not be viewed as cosmetic interventions but rather as medical treatments, “not only for weight loss but to reverse obesity-associated complications.”
Moreover, they should be used “as an adjunct to lifestyle changes,” emphasized Cornier. “We want our patients to have a high-quality diet with high protein content, fluid, vitamins, and minerals, and we want them to exercise.” Especially with the concern of potential loss of muscle mass with these agents, “resistance exercise might help mitigate that concern.”
Recently published recommendations can assist clinicians in guiding patients taking GLP-1 RAs to optimize nutrition. The recommendations note that patients should be referred to a registered dietitian to “complement and support” treatment with anti-obesity medications.
What Do Patients Want?
Despite the ever-rising popularity of GLP-1 RAs, a new national survey of over 2200 US adults conducted by the Physicians Committee for Responsible Medicine suggests that most Americans don’t want to use them. Among those who wanted to lose weight, almost three-quarters “disagreed” or “strongly disagreed” with the idea of taking a weight-loss injectable, and 68% of those who wanted to lose weight “agreed” or “strongly agreed” that they would be willing to try a plant-based diet, if it could lead to significant weight loss.
Moreover, many individuals treated with GLP-1 RAs discontinue their use, despite the probability of regaining the weight, according to a report that found only 46.3% of GLP-1 users were still taking the medications at 6 months and only 32.3% at 1 year. The authors commented that their real-world findings show a “substantially lower” 1-year persistence rate, compared with the rate reported in clinical trials. They suggest that the financial burden (> $12,000/year) may contribute to discontinuation.
Discontinuation of GLP-1 RAs can lead to worsening cardiometabolic parameters, with a potential increased risk for adverse outcomes; moreover, weight cycling (“yo-yo dieting”) carries its own risks. In light of these concerns, it’s particularly important to select appropriate patients and to determine whether potential short-term therapy has any enduring benefit.
Acosta agreed. “It’s exciting when looking at the data on how to find the best responders and who should make the effort to take these medications — not only in terms of side effects but also in terms of cost and which patients will receive maximum benefits and should be covered by insurance.”
Drucker has served as a consultant or speaker for Altimmune, Amgen, AstraZeneca, Arrowhead, Boehringer Ingelheim, Kallyope, Merck Research Laboratories, Novo Nordisk, Pfizer, and Zealand Pharma. He holds nonexercised options in Kallyope. Mount Sinai Hospital receives research support for investigator-initiated studies in the Drucker laboratory from Amgen, Novo Nordisk, Pfizer, and Zealand Pharma. Gila Therapeutics and Phenomix Sciences have licensed Acosta’s research technologies from University of Florida and Mayo Clinic. Acosta received consultant fees in the last 5 years from Rhythm Pharmaceuticals, Gila Therapeutics, Amgen, General Mills, Regeneron Pharmaceuticals, Boehringer Ingelheim, Novo Nordisk, Currax, Nestlé, Phenomix Sciences, Bausch Health, and Rare Disease. He received funding support from the National Institutes of Health, Vivus Pharmaceuticals, Novo Nordisk, Apollo Endosurgery, Satiogen Pharmaceuticals, Spatz Medical, Rhythm Pharmaceuticals, Regeneron Pharmaceuticals, Boehringer Ingelheim, and Novo Nordisk. In the past, Cornier has served as a consultant for Novo Nordisk.
A version of this article first appeared on Medscape.com.
Rates of overweight and obesity have more than doubled in the United States during the last three decades, according to a new analysis. By 2050, it’s anticipated that 213 million adults (age, > 25 years) and 43 million children and adolescents will have overweight or obesity. The results led authors of a study to describe obesity as having reached a “crisis point” requiring urgent action and interventions.
Are glucagon-like peptide 1 receptor agonists (GLP-1 RAs), originally developed and prescribed for diabetes and now approved for weight loss, the answer?
Their popularity is certainly surging. Between the last 6 months of 2022 vs the last 6 months of 2024, the number of patients prescribed GLP-1 RAs increased by 132.6%. This is also reflected in a shift in public awareness, with a recent survey of US adults finding that 32% of respondents had heard “a lot” about these drugs, up from 19% in 2023.
GLP-1 RAs (including tirzepatide, which targets not only the GLP-1 receptor but also the glucose-dependent insulinotropic polypeptide receptor) have shown efficacy in weight loss. A 2022 review and meta-analysis of 22 trials (17,183 patients) found that 50.2% and 17.5% of those treated with GLP-1 RAs had a ≥ 5% and ≥ 10% weight loss, respectively, compared with placebo. A 2023 review of 41 trials (15,135 patients) found that compared with controls, GLP-1 RAs significantly reduced body weight, body mass index, waist circumference, and waist-to-hip ratio.
“GLP-1 RAs are great medications,” Andres Acosta, MD, PhD, director of the Precision Medicine for Obesity Laboratory, Mayo Clinic, Rochester, Minnesota, told Medscape Medical News. “We’ve been using them for almost two decades. But now there’s excitement about their utility in treating obesity.”
Treating the Four Categories of Obesity
Daniel Drucker, MD, senior investigator at the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada, is a pioneer in diabetes treatment and particularly in the development of GLP-1 RAs. Drucker told Medscape Medical News that despite the efficacy and enormous potential of GLP-1 RAs, “we know some people don’t lose much weight when taking these medicines and others don’t feel well and can’t take them.”
The number of individuals who don’t respond to or aren’t able to tolerate GLP-1 RAs “might be small — less than 10% of people who try to take them — but we don’t fully understand the differences in response across different individuals,” Drucker said.
Acosta agreed, adding that it’s “essential for us to identify who will be the best responders, as we do with medications for other conditions, such as cancer and cardiovascular disease.”
Acosta’s group has spent more than a decade engaged in efforts to identify unique characteristics among patients with obesity and has succeeded in identifying four obesity phenotypes.
“What matters in the space of GLP-1 is that using this classification, we can identify the best responders and those who don’t respond.”
The first phenotype, described as “Hungry Gut” (HG), includes patients with abnormal postprandial satiety. “Although they may be satiated at the end of a meal, they have accelerated gastric emptying and therefore feel hungry between meals and want to keep eating,” he said.
There are also patients who experience abnormal satiety during meals. According to Acosta, these are the patients who will return to the table for second and third helpings. “They don’t feel full and continue to eat more and more in a single sitting” — a phenomenon referred to as “Hungry Brain.”
The third phenotype — “Emotional Hunger” — consists of people who are “hedonic” about food or engage in emotional eating behavior, whereas in the fourth group, people have “an abnormal metabolism in which they don’t burn enough calories. They have an inefficient metabolic rate.” This latter phenomenon is called “Slow Burn.”
Acosta and colleagues randomized 312 patients attending a weight management center to phenotype-guided or non–phenotype-guided treatment with anti-obesity medications (phentermine, phentermine/topiramate, bupropion/naltrexone, lorcaserin, and liraglutide). The phenotype-guided approach was associated with a 1.75-fold greater weight loss after 1 year than the non–phenotype-guided approach (mean weight loss, 15.9% vs 9.0%, respectively).
GLP-1 RAs: Not One-Size-Fits-All
Acosta’s group has developed a genetic test that uses patients’ saliva to identify their obesity phenotype, with the aim of predicting the best responders to GLP-1 RAs. The test, MyPhenome genetic obesity test, is licensed by Acosta’s lab and available through Phenomix Sciences.
Acosta and colleagues presented their findings at the American Gastroenterological Association’s 2024 annual meeting regarding a machine-learning gene risk score (ML-GRS) they developed to predict HG, based on saliva and blood samples. Their genetic studies generated a ML-GRS that classified participants with obesity along a continuum from “HG Positive” (HG+) to “HG Negative” (HG−). Compared with the HG− participants, those who were HG+ had superior total body weight loss with semaglutide at 9 and 12 months. When used to predict response, the ML-GRS had an area under the curve of 0.76 (P = .04) and a positive predictive value of 0.95.
According to Acosta, HG+ patients are “the best responders to the GLP-1 RAs, although we don’t yet understand the mechanism of why they have the phenomenon of abnormal postprandial satiety. It may be an abnormal genetic pathway or abnormal secretion of GLP-1. More studies are needed.”
He noted that GLP-1 RAs “might also be helpful with the second [Hungry Brain] category, but these patients do better with phentermine-topiramate,” as demonstrated in a 2023 study conducted by Acosta and colleagues.
His group has also studied which lifestyle interventions are most effective for each phenotype. “When a unique lifestyle intervention targeting each phenotype was applied, patients lost more weight and had greater metabolic improvement,” he reported.
“Treating obesity no longer needs to be trial-and-error, but should be done using precision medicine because one size doesn’t fit all,” Acosta said.
Concerning Side Effects
The popular media has featured stories about individuals who took GLP-1 RAs for weight loss and experienced serious side effects, including a recent account of a British nurse who died after taking tirzepatide. As reported by the BBC, the nurse’s death certificate listed multiple organ failure, septic shock, and pancreatitis as the immediate causes of death, with the “use of prescribed tirzepatide” recorded as a contributing factor. The report went on to note that there were 23 suspected deaths in the United Kingdom tied to semaglutide since 2019.
Beyond brand-name products, there are also risks associated with GLP-1 RAs manufactured by compounding pharmacies. In early November, CNN reported that compounded semaglutide has been linked to at least 10 deaths. Because of a prior shortage of tirzepatide, the US Food and Drug Administration (FDA) had allowed compounding pharmacies to manufacture the drug. In October, the FDA clarified that it won’t take legal action against compounders, even now that the shortage has been resolved.
A pharmacovigilance study using the FDA Adverse Event Reporting System identified “potential safety signals of increased mortality and serious adverse event reporting” associated with certain GLP-1 RAs — especially in younger patients and women (P < .0001 for both groups).
The most common side effects reported with GLP-1 RAs are gastrointestinal events, such as nausea, diarrhea, constipation, and vomiting. Most occur during dose initiation and escalation and wane over the following weeks. However, studies have also reported severe side effects, including a higher risk for pancreatitis, bowel obstruction, and gastroparesis, as well as a significantly higher risk for gallbladder and biliary diseases. In fact, according to one study, patients with diabetes taking GLP-1 RAs reported gastrointestinal-related issues as a “prominent factor” in their decision to discontinue taking these medications.
Several types of cancer are potentially associated with GLP-1 RAs, but findings regarding this potential link have been inconsistent. In a recent review article, Drucker noted there were only inconsistent data linking GLP-1 RAs with thyroid cancer and medullary thyroid cancer and that their potential association with pancreatic has “not been supported by results from randomized controlled trials or real-world data.”
Concerns have been raised about loss of lean mass and muscle strength and function, especially in older individuals with obesity and advanced liver, cardiovascular, or kidney disease. However, as Drucker pointed out in his review article, muscle function may not correlate with the loss of lean mass. In fact, there are “consistent reductions” in lean mass after bariatric surgery, but “little evidence to date for impairment of muscle function.” He added that newer GLP-1 agents under development for obesity treatment are focusing on “developing complementary therapies that preferentially reduce adipose tissue, while sparing lean mass.”
As covered by Medscape Medical News, there have been reports of potential suicidal ideation associated with GLP-1 RAs. This triggered a 2023 review from the European Medicines Agency. However, recent results from a cohort study and a post hoc analysis of randomized controlled trials concluded that there is no evidence that these drugs increase suicidal ideation or behavior.
In early November, the FDA updated the labels for the GLP-1 RAs to include a warning regarding pulmonary aspiration during general anesthesia or deep sedation. Guidance from a group of societies, led by the American Society of Anesthesiologists, contains recommendations regarding nuances of addressing this concern in surgical patients taking these agents.
Not a Standalone Treatment
Marc-Andre Cornier, MD, professor of medicine, James A. Keating Endowed Chair in Diabetes, and director of the Division of Endocrinology, Diabetes and Metabolic Diseases, Department of Medicine, Medical University of South Carolina, Charleston, South Carolina, told Medscape Medical News that GLP-1 RAs should not be viewed as cosmetic interventions but rather as medical treatments, “not only for weight loss but to reverse obesity-associated complications.”
Moreover, they should be used “as an adjunct to lifestyle changes,” emphasized Cornier. “We want our patients to have a high-quality diet with high protein content, fluid, vitamins, and minerals, and we want them to exercise.” Especially with the concern of potential loss of muscle mass with these agents, “resistance exercise might help mitigate that concern.”
Recently published recommendations can assist clinicians in guiding patients taking GLP-1 RAs to optimize nutrition. The recommendations note that patients should be referred to a registered dietitian to “complement and support” treatment with anti-obesity medications.
What Do Patients Want?
Despite the ever-rising popularity of GLP-1 RAs, a new national survey of over 2200 US adults conducted by the Physicians Committee for Responsible Medicine suggests that most Americans don’t want to use them. Among those who wanted to lose weight, almost three-quarters “disagreed” or “strongly disagreed” with the idea of taking a weight-loss injectable, and 68% of those who wanted to lose weight “agreed” or “strongly agreed” that they would be willing to try a plant-based diet, if it could lead to significant weight loss.
Moreover, many individuals treated with GLP-1 RAs discontinue their use, despite the probability of regaining the weight, according to a report that found only 46.3% of GLP-1 users were still taking the medications at 6 months and only 32.3% at 1 year. The authors commented that their real-world findings show a “substantially lower” 1-year persistence rate, compared with the rate reported in clinical trials. They suggest that the financial burden (> $12,000/year) may contribute to discontinuation.
Discontinuation of GLP-1 RAs can lead to worsening cardiometabolic parameters, with a potential increased risk for adverse outcomes; moreover, weight cycling (“yo-yo dieting”) carries its own risks. In light of these concerns, it’s particularly important to select appropriate patients and to determine whether potential short-term therapy has any enduring benefit.
Acosta agreed. “It’s exciting when looking at the data on how to find the best responders and who should make the effort to take these medications — not only in terms of side effects but also in terms of cost and which patients will receive maximum benefits and should be covered by insurance.”
Drucker has served as a consultant or speaker for Altimmune, Amgen, AstraZeneca, Arrowhead, Boehringer Ingelheim, Kallyope, Merck Research Laboratories, Novo Nordisk, Pfizer, and Zealand Pharma. He holds nonexercised options in Kallyope. Mount Sinai Hospital receives research support for investigator-initiated studies in the Drucker laboratory from Amgen, Novo Nordisk, Pfizer, and Zealand Pharma. Gila Therapeutics and Phenomix Sciences have licensed Acosta’s research technologies from University of Florida and Mayo Clinic. Acosta received consultant fees in the last 5 years from Rhythm Pharmaceuticals, Gila Therapeutics, Amgen, General Mills, Regeneron Pharmaceuticals, Boehringer Ingelheim, Novo Nordisk, Currax, Nestlé, Phenomix Sciences, Bausch Health, and Rare Disease. He received funding support from the National Institutes of Health, Vivus Pharmaceuticals, Novo Nordisk, Apollo Endosurgery, Satiogen Pharmaceuticals, Spatz Medical, Rhythm Pharmaceuticals, Regeneron Pharmaceuticals, Boehringer Ingelheim, and Novo Nordisk. In the past, Cornier has served as a consultant for Novo Nordisk.
A version of this article first appeared on Medscape.com.
Vaping Linked to Higher Risk of Blurred Vision & Eye Pain
TOPLINE:
Adults who use electronic cigarettes (e-cigarettes/vapes) had more than double the risk for developing uveitis than nonusers, with elevated risks persisting for up to 4 years after initial use. This increased risk was observed across all age groups and affected both men and women as well as various ethnic groups.
METHODOLOGY:
- Researchers used the TriNetX global database, which contains data from over 100 million patients across the United States, Europe, the Middle East, and Africa, to examine the risk for developing uveitis among e-cigarette users.
- 419,325 e-cigarette users over the age of 18 years (mean age, 51.41 years; 48.65% women) were included, based on diagnosis codes for vaping and unspecified nicotine dependence.
- The e-cigarette users were propensity score–matched to non-e-cigarette-users.
- People were excluded if they had comorbid conditions that might have influenced the risk for uveitis.
- The primary outcome measure was the first-time encounter diagnosis of uveitis using diagnosis codes for iridocyclitis, unspecified choroidal inflammation, posterior cyclitis, choroidal degeneration, retinal vasculitis, and pan-uveitis.
TAKEAWAY:
- E-cigarette users had a significantly higher risk for developing uveitis than nonusers (hazard ratio [HR], 2.53; 95% CI, 2.33-2.76 ), for iridocyclitis (HR, 2.59), unspecified chorioretinal inflammation (HR, 2.34), and retinal vasculitis (HR, 1.95).
- This increased risk for uveitis was observed across all age groups, affecting all genders and patients from Asian, Black or African American, and White ethnic backgrounds.
- The risk for uveitis increased as early as within 7 days after smoking an e-cigarettes (HR, 6.35) and was present even at 4 years (HR, 2.58) after initial use.
- A higher risk for uveitis was observed among individuals with a history of both e-cigarette and traditional cigarette use than among those who used traditional cigarettes only (HR, 1.39).
IN PRACTICE:
“This study has real-world implications as clinicians caring for patients with e-cigarette history should be aware of the potentially increased risk of new-onset uveitis,” the authors wrote.
SOURCE:
The study was led by Alan Y. Hsu, MD, from the Department of Ophthalmology at China Medical University Hospital in Taichung, Taiwan, and was published online on November 12, 2024, in Ophthalmology.
LIMITATIONS:
The retrospective nature of the study limited the determination of direct causality between e-cigarette use and the risk for uveitis. The study lacked information on the duration and quantity of e-cigarette exposure, which may have impacted the findings. Moreover, researchers could not isolate the effect of secondhand exposure to vaping or traditional cigarettes.
DISCLOSURES:
Study authors reported no relevant financial disclosures.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Adults who use electronic cigarettes (e-cigarettes/vapes) had more than double the risk for developing uveitis than nonusers, with elevated risks persisting for up to 4 years after initial use. This increased risk was observed across all age groups and affected both men and women as well as various ethnic groups.
METHODOLOGY:
- Researchers used the TriNetX global database, which contains data from over 100 million patients across the United States, Europe, the Middle East, and Africa, to examine the risk for developing uveitis among e-cigarette users.
- 419,325 e-cigarette users over the age of 18 years (mean age, 51.41 years; 48.65% women) were included, based on diagnosis codes for vaping and unspecified nicotine dependence.
- The e-cigarette users were propensity score–matched to non-e-cigarette-users.
- People were excluded if they had comorbid conditions that might have influenced the risk for uveitis.
- The primary outcome measure was the first-time encounter diagnosis of uveitis using diagnosis codes for iridocyclitis, unspecified choroidal inflammation, posterior cyclitis, choroidal degeneration, retinal vasculitis, and pan-uveitis.
TAKEAWAY:
- E-cigarette users had a significantly higher risk for developing uveitis than nonusers (hazard ratio [HR], 2.53; 95% CI, 2.33-2.76 ), for iridocyclitis (HR, 2.59), unspecified chorioretinal inflammation (HR, 2.34), and retinal vasculitis (HR, 1.95).
- This increased risk for uveitis was observed across all age groups, affecting all genders and patients from Asian, Black or African American, and White ethnic backgrounds.
- The risk for uveitis increased as early as within 7 days after smoking an e-cigarettes (HR, 6.35) and was present even at 4 years (HR, 2.58) after initial use.
- A higher risk for uveitis was observed among individuals with a history of both e-cigarette and traditional cigarette use than among those who used traditional cigarettes only (HR, 1.39).
IN PRACTICE:
“This study has real-world implications as clinicians caring for patients with e-cigarette history should be aware of the potentially increased risk of new-onset uveitis,” the authors wrote.
SOURCE:
The study was led by Alan Y. Hsu, MD, from the Department of Ophthalmology at China Medical University Hospital in Taichung, Taiwan, and was published online on November 12, 2024, in Ophthalmology.
LIMITATIONS:
The retrospective nature of the study limited the determination of direct causality between e-cigarette use and the risk for uveitis. The study lacked information on the duration and quantity of e-cigarette exposure, which may have impacted the findings. Moreover, researchers could not isolate the effect of secondhand exposure to vaping or traditional cigarettes.
DISCLOSURES:
Study authors reported no relevant financial disclosures.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Adults who use electronic cigarettes (e-cigarettes/vapes) had more than double the risk for developing uveitis than nonusers, with elevated risks persisting for up to 4 years after initial use. This increased risk was observed across all age groups and affected both men and women as well as various ethnic groups.
METHODOLOGY:
- Researchers used the TriNetX global database, which contains data from over 100 million patients across the United States, Europe, the Middle East, and Africa, to examine the risk for developing uveitis among e-cigarette users.
- 419,325 e-cigarette users over the age of 18 years (mean age, 51.41 years; 48.65% women) were included, based on diagnosis codes for vaping and unspecified nicotine dependence.
- The e-cigarette users were propensity score–matched to non-e-cigarette-users.
- People were excluded if they had comorbid conditions that might have influenced the risk for uveitis.
- The primary outcome measure was the first-time encounter diagnosis of uveitis using diagnosis codes for iridocyclitis, unspecified choroidal inflammation, posterior cyclitis, choroidal degeneration, retinal vasculitis, and pan-uveitis.
TAKEAWAY:
- E-cigarette users had a significantly higher risk for developing uveitis than nonusers (hazard ratio [HR], 2.53; 95% CI, 2.33-2.76 ), for iridocyclitis (HR, 2.59), unspecified chorioretinal inflammation (HR, 2.34), and retinal vasculitis (HR, 1.95).
- This increased risk for uveitis was observed across all age groups, affecting all genders and patients from Asian, Black or African American, and White ethnic backgrounds.
- The risk for uveitis increased as early as within 7 days after smoking an e-cigarettes (HR, 6.35) and was present even at 4 years (HR, 2.58) after initial use.
- A higher risk for uveitis was observed among individuals with a history of both e-cigarette and traditional cigarette use than among those who used traditional cigarettes only (HR, 1.39).
IN PRACTICE:
“This study has real-world implications as clinicians caring for patients with e-cigarette history should be aware of the potentially increased risk of new-onset uveitis,” the authors wrote.
SOURCE:
The study was led by Alan Y. Hsu, MD, from the Department of Ophthalmology at China Medical University Hospital in Taichung, Taiwan, and was published online on November 12, 2024, in Ophthalmology.
LIMITATIONS:
The retrospective nature of the study limited the determination of direct causality between e-cigarette use and the risk for uveitis. The study lacked information on the duration and quantity of e-cigarette exposure, which may have impacted the findings. Moreover, researchers could not isolate the effect of secondhand exposure to vaping or traditional cigarettes.
DISCLOSURES:
Study authors reported no relevant financial disclosures.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Survey Study Shows How to Reduce Family Physician Burnout
Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.
In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.
Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.
“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
More Than 10,000 Physicians; 100% Response Rate
The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.
The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.
Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).
Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
Numbers Needed to Treat
“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.
The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.
“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”
Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.
Fee-for-service models are often painted as the culprit, she noted.
“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
Medical Assistants (MAs) Replacing Nurses on Core Teams
In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.
“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.
Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.
Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”
Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.
Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.
He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.
“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.
Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.
She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
Nearly 30 Hours a Week of EHR Work at Home
Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.
She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”
She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.
The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”
This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.
In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.
Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.
“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
More Than 10,000 Physicians; 100% Response Rate
The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.
The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.
Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).
Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
Numbers Needed to Treat
“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.
The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.
“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”
Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.
Fee-for-service models are often painted as the culprit, she noted.
“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
Medical Assistants (MAs) Replacing Nurses on Core Teams
In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.
“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.
Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.
Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”
Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.
Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.
He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.
“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.
Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.
She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
Nearly 30 Hours a Week of EHR Work at Home
Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.
She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”
She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.
The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”
This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Family physician burnout rates are among the highest in medicine. More than half (51%) reported burnout in a Medscape report from January 2024; only emergency physicians (63%) and obstetricians/gynecologists and oncologists (both 53%) had higher rates.
In a recent study, researchers examined what’s driving the burnout through a serial cross-sectional survey of family physicians. Authors conclude that reducing burnout may be most effective with a focus on two factors: Decreasing time spent at home on electronic health record (EHR) tasks and building stronger nurse-physician teams.
Findings by Lisa S. Rotenstein, MD, MBA, MSc, Division of Clinical Informatics, Department of Medicine, University of California, San Francisco, and colleagues were published in JAMA Network Open. The findings debunk some longstanding assumptions, Christine A. Sinsky, MD, vice president of professional satisfaction with the American Medical Association, wrote in an editorial.
“This study advances our understanding that addressing physician burnout is not about more EHR training and not specifically about moving to paying for value; rather, it is about developing stronger nurse-physician core teams. These are novel and important findings with actionable lessons for physician and health system leaders,” Sinsky wrote.
More Than 10,000 Physicians; 100% Response Rate
The study included 10,315 physicians who answered questions related to burnout on the American Board of Family Medicine’s Continuous Certification Questionnaire between 2017 and 2023. Researchers achieved a 100% response rate by requiring diplomates to complete the survey before submitting their exam.
The median age of respondents was 50 years. More than half (57.8%) were employees, 11.3% were full owners of their practices, and 3.2% were contractors. Responses indicated that 10% practiced as solo physicians, 20.4% were in a practice with more than 20 physicians, and the rest were in a practice with 2-19 physicians. More than three fourths of the physicians practiced in an urban/suburban setting, and 13.5% practiced in a rural setting.
Physicians’ perceptions that EHR use at home was appropriate were associated with 0.58 times the odds of burnout (95% CI, 0.53-0.64; P < .001), and high team efficiency was associated with 0.61 times the odds of burnout (95% CI, 0.56-0.67).
Physician collaboration with a registered nurse was associated with greater odds of high team efficiency (odds ratio [OR], 1.35; 95% CI, 1.22-1.50). Collaboration with a physician assistant was associated with greater odds of appropriate home EHR time (OR, 1.13; 95% CI, 1.03-1.24).
Numbers Needed to Treat
“When translated to a number needed to treat, these ORs suggest that eight additional physicians perceiving appropriate home EHR time would result in prevention of one additional case of burnout, and nine additional physicians perceiving high team efficiency would result in prevention of one case of burnout,” the authors wrote.
The authors also noted that EHR proficiency was not associated with burnout (OR, 0.93; 95% CI, 0.85-1.02; P = .12). Self-reported EHR proficiency remained high and steady over the study period.
“It is time to lay to rest the myth of the technology-resistant physician,” Sinsky wrote in the editorial. “The problem is not the end user.”
Sinsky said the findings also show that value-based compensation “is not a panacea” and, in fact, participation in such payment programs was associated with both more time working on the EHR at home and lower team efficiency.
Fee-for-service models are often painted as the culprit, she noted.
“The key in either compensation model is to direct sufficient financial resources to primary care to cover the costs of optimal team size, skill level, and stability. In my experience, this is a minimum of two clinical assistants (including at least one nurse) per 1.0 clinical full-time equivalent physician, with the same team of individuals working together on a daily basis to develop trust, reliance, and efficiencies.”
Medical Assistants (MAs) Replacing Nurses on Core Teams
In many cases, nurses have been replaced on core clinical teams by MAs, who, with a narrower scope of practice, put work back on the physician’s plate, Sinsky noted, and the MAs also often work in pools rather than with one physician.
“The result is that nurses in many settings are sequestered in a room with a computer and a telephone, with limited direct interactions with their patients or physicians, and physicians spend more time each day on tasks that do not require their medical training,” Sinsky wrote.
Strengths of the study include the large sample size, a 100% response rate to the survey, and consistency of findings over the 6 years.
Steven Waldren, MD, MS, chief medical informatics officer for the American Academy of Family Physicians, said the results of the study confirm what the organization knows to be true through various analyses and talks with doctors: “Even if you can just focus on documentation and improve that, it gives docs hope that other things can happen and actually improve. We saw a decrease in burnout in just solving that one problem.”
Team-based care also allows physicians to talk through challenges and off-load tasks, which allows them to focus on patient care, he said.
Waldren added that some technology upgrades can help reduce burnout without adding staff. He pointed to promising technology in managing EHR inbox messages and in artificial intelligence (AI) solutions for developing a visit summary and patient instructions that can then be reviewed by a physician.
He gave an example of ambient documentation. “We’ve seen that it reduces the amount of documentation time by 60%-70%,” he said. The products in this space record the physician-patient conversation and generate a summary to be reviewed by the physician for accuracy.
“These tools now are highly accurate,” he said. They are also able to remove clinically irrelevant details. He said, for example, if a patient talks about her recent golf outing on a trip to Ireland, the program will record only that she recently had an international trip to Ireland and remove the golf details. The technology has been available for many months, he said.
Sonia Rivera-Martinez, DO, an associate professor of family medicine at the New York Institute of Technology College of Osteopathic Medicine in Old Westbury, New York, said AI solutions are impressive but expensive, which is why her practice has not upgraded to AI-generated visit summaries.
She said even in her academic setting where there is less pressure to see several patients per hour, after-hours EHR work is a reality for her and her colleagues as seeing patients is paired with the demands of teaching students. Her practice is also part of an accountable care organization, which adds its own set of documentation demands.
Nearly 30 Hours a Week of EHR Work at Home
Rivera-Martinez estimated that she spends 20-30 hours each week doing EHR tasks at home and said the study authors have highlighted an important problem.
She said she has also seen the value of strong nurse-physician teams in her practice. The two nurses in her practice, for instance, know they have permission to administer flu shots and do other routine tasks without the physicians having to place the order. “But I can’t say it eliminates having to do work outside (of work hours).”
She said before current EHR documentation demands, “I used to be able to finish a progress note in less than 5 minutes.” Now, she said, with her medically complex patient population, it takes her 20-30 minutes to complete a patient’s progress note.
The findings of the study have particular significance with the rising prevalence of burnout among family physicians, the authors wrote. “Clinical leaders and policymakers seeking to develop care delivery models that enable sustainable primary care practice should focus on ensuring adequate team support and acceptable EHR workloads for physicians.”
This study was funded by the United States Office of the National Coordinator for Health Information Technology and Department of Health and Human Services. Additionally, Rotenstein’s time was funded by The Physicians Foundation. Rotenstein reported personal fees from Phreesia; stock grants from serving on the advisory board of Augmedix; and grants from the Agency for Healthcare Research and Quality, American Medical Association, The Physicians Foundation, and Association of Chiefs and Leaders of General Internal Medicine outside the submitted work. Nathaniel Hendrix reported grants from the Office of the National Coordinator for Health Information Technology during the conduct of the study. One coauthor reported a cooperative agreement from the Office of the National Coordinator for Health Information Technology (now Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology). Another coauthor reported that the University of California, San Francisco, has received funding from the Office of the National Coordinator for Health Information Technology to partner with the American Board of Family Medicine to revise the survey over time to better capture interoperability. Sinsky, Rivera-Martinez, and Waldren reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
How to Manage Patients on GLP-1s Before Surgery
, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.
The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.
Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”
Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.
The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.
But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:
Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”
“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”
“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”
Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”
“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”
“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”
Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”
“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”
Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.
“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”
Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”
“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”
Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”
“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”
Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
A version of this article first appeared on Medscape.com.
, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.
The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.
Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”
Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.
The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.
But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:
Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”
“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”
“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”
Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”
“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”
“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”
Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”
“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”
Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.
“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”
Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”
“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”
Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”
“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”
Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
A version of this article first appeared on Medscape.com.
, as does the US Food and Drug Administration’s (FDA’s) labeling for the drugs. The changes can be challenging to keep up with, and endocrinologists seem to be making their own decisions based on clinical experience and their interpretations of the potential impact and value of the emerging information.
The latest FDA label change warns about the risk for pulmonary aspiration but notes “insufficient” data to inform recommendations to mitigate the risk in vulnerable patients. Yet, the latest multi-society guidance, led by the American Society of Anesthesiologists (ASA) and based on consensus, not evidence, has nuanced advice for managing patients at risk.
Does the FDA’s label change make a difference regarding the multi-society guidance, which was published earlier? “The answer is no,” Girish Joshi, MD, vice chair, ASA Committee on Practice Parameters, told this news organization. “The concern of increased pulmonary aspiration in patients who are on GLP-1 receptor agonists has been known, and that concern still exists. So, we started with not an assumption but the premise that patients on GLP-1 receptor agonists are at a higher risk of aspiration during sedation, analgesia, and/or general anesthesia. The FDA basically confirms what we say in the guidance.”
Joshi, professor in the Anesthesiology and Pain Management Department at UT Southwestern Medical Center, Dallas, aimed to make the guidance, which was published simultaneously in several society journals, more implementable with a letter to the editor of Anesthesiology. The key, he said, is to identify patients at higher risk for aspiration; all others would follow treatment as usual.
The letter highlights three overarching recommendations and then expands upon them: Standardized preoperative assessment for risk for delayed gastric emptying (yes/no); selective preoperative care plan based on delayed gastric emptying assessment and shared decision-making; and on the day of the procedure, reassess for delayed gastric emptying and mitigate risk if there is clinical concern.
But it seems as though, for now, endocrinologists are managing these patients as they see fit, within the parameters of any institutional guidance requirements. Here is what they said about their practice:
Amy E. Rothberg, MD, DABOM, director of the Weight Management Program & Rewind at the University of Michigan, Ann Arbor, Michigan, said, “I think it makes sense to inform our patients of the labeling and rare but potential adverse effects if they intend to undergo anesthesia for a scheduled procedure/surgery. There is never no risk of aspiration during anesthesia.”
“I find it a bit curious that ASA implies that those who experience GI side effects are more likely than those who do not to have this potential risk. I doubt there is evidence that those without GI side effects are necessarily ‘safer’ and a study to determine that is unlikely to take be conducted.”
“My institution does require a 1-week pause on GLP-1s for those undergoing anesthesia for surgery,” she added. “That’s not evidence-based either, but probably reduces the risk of aspiration during anesthesia — but I don’t know what the actual denominator is for aspiration in those who continued vs those who took a pause from GLP-1s. Pausing does certainly (anecdotally) increase the traffic of communications between physicians and their patients about what to do in the interval.”
Anne Peters, MD, a professor of clinical medicine and a clinical scholar at the Keck School of Medicine of the University of Southern California, Los Angeles, said, “The FDA label change is a warning that really doesn’t say exactly who on GLP-1 RAs is at highest risk or what to do, and if any intervention has been shown to help. The ASA recommendations seem much more nuanced and practical, including point-of-care gastric ultrasound to see if there is retained food/fluid prior to surgery.”
“In my practice, I individualize what I say, depending on the person and the circumstance,” she said. “Mostly, I have people hold one dose before planned surgery, so they have been 10 days at least without a dose. But if worried about gastrointestinal symptoms or gastroparesis, I have them do a clear liquid diet for 24 hours presurgery. Or at least avoid heavy fat meals the day before.”
“There is a risk of aspiration with anything that slows gastric emptying — maybe even in patients with gastroparesis at baseline due to physiologic, not pharmacological, reasons — and anesthesiologists should be aware of the need to assess patients individually.”
Michael A. Weintraub, MD, of NYU Langone Health Diabetes & Endocrine Associates in New York City, observed, “The risk of a pulmonary aspiration event with GLP-1 medication is quite rare, but not zero. On the other hand, stopping the GLP-1 can cause hyperglycemia or rebound weight gain. Furthermore, it can become complicated to restart GLP1 dosing, particularly given the existing medication shortages.”
“In most cases, stopping a weekly GLP-1 medication 1 week prior to the procedure minimizes the risks of pulmonary aspiration and prevents any worsening hyperglycemia or weight gain,” he said. However, taking the drug 7 days prior to the procedure is optimal. “That way, they would be due for the next dose on the day of the procedure, and taking it the day following procedure minimizes disruption in their once-weekly regimen.”
Malini Gupta, MD, director of G2Endo Endocrinology & Metabolism, Memphis, Tennessee, advised that physicians weigh the risk of stopping the medication (which can cause a glycemic spike) vs risk for aspiration.
“In my opinion, all patients should follow a strict liquid diet or NPO status prior to a surgery to further decrease the risk of aspiration,” she said. “I generally hold the GLP-1 RA for a week before a surgery. If additional glycemic control is necessary, I will add to or adjust one of the patient’s other diabetes medications.”
Jaime Almandoz, MD, associate professor of medicine and medical director of the Weight Wellness Program in Dallas, said, “As endocrinologists, we typically rely on our anesthesia colleagues for guidance on perioperative management. In light of emerging guidelines for holding GLP-1 medications, we also recommend patients adopt a liquid diet 24 hours prior to surgery, along with the fasting protocol.”
“For those managing diabetes with GLP-1 therapies, it is crucial to establish a blood sugar management plan while off these medications, especially during fasting or postoperative periods, which can be further influenced by many factors, including nausea, pain medications, and antibiotics after the procedure.”
Joshi added that at Parkland Hospital in Dallas, “we do a huge number of cases using the same information. We identify patients who are at risk, and then we tell our proceduralists and our surgeons if they’re in the escalating phase of the dosing or if they have GI symptoms; don’t even schedule them as an elective case; wait till the escalation phase is over and then schedule them.”
“That way,” he said, “it becomes logistically easy to manage because the recommendation from the group is that patients who are at higher risk should receive a 24-hour liquid diet — the same as colonoscopy. But sometimes it can be challenging to do so.”
Joshi has received honoraria for consultation from Merck Sharp & Dohme, Vertex Pharmaceuticals, and Haisco-USA Pharmaceuticals. Gupta is on the speakers bureau for Amgen (Tepezza) and IBSA (Tirosint) and is a creative consultant for AbbVie. Almandoz serves on advisory boards for Novo Nordisk, Eli Lilly, and Boehringer Ingelheim. The other experts declared no relevant relationships.
A version of this article first appeared on Medscape.com.
Continuous Glucose Monitors for All? Opinions Remain Mixed
The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.
There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes?
The short answer to these questions is, we don’t know.
“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.
“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.
“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.”
Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.
“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.”
Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.
“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
Potential Benefits Right Now
Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.
“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.
He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.
Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.
“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”
Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”
“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”
Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”
Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.”
Potential Downsides
Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”
Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.
Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.
Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”
Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.
“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
Educate Patients, Primary Care Physicians
To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use.
“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”
This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.
“A discrepancy of 20% is totally acceptable for that reason,” Bao said.
She has also seen several examples where patients were misled by their CGM when its censor became dislodged.
“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.”
At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.
Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.
“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”
Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.”
“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”
Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.
There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes?
The short answer to these questions is, we don’t know.
“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.
“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.
“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.”
Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.
“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.”
Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.
“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
Potential Benefits Right Now
Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.
“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.
He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.
Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.
“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”
Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”
“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”
Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”
Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.”
Potential Downsides
Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”
Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.
Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.
Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”
Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.
“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
Educate Patients, Primary Care Physicians
To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use.
“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”
This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.
“A discrepancy of 20% is totally acceptable for that reason,” Bao said.
She has also seen several examples where patients were misled by their CGM when its censor became dislodged.
“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.”
At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.
Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.
“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”
Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.”
“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”
Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
The recent US Food and Drug Administration (FDA) clearance of two over-the-counter (OTC) continuous glucose monitors (CGMs) — Dexcom’s Stelo and Abbott’s Lingo — has sparked interest in potentially expanding their use to those without diabetes or prediabetes.
There are several valid questions about how the general population might benefit from CGMs. Can they motivate those struggling with overweight to shed pounds? Would they prompt users to follow more healthful eating patterns? Can they act as a canary in the coal mine, alerting users to prediabetes?
The short answer to these questions is, we don’t know.
“Glucose levels fluctuate in everyone in response to meals, exercise, stress, etc, but there has been no credible research to support CGM use by most people who do not have diabetes,” Jill Crandall, MD, chief of endocrinology at Albert Einstein College of Medicine and Montefiore Health System in New York City, said in an interview.
“The utility of CGM for people without diabetes hasn’t been established and the drive to market CGM as an OTC device seems largely driven by financial considerations,” Crandall said. She advocates instead for a strategy directed at more meaningful objectives.
“For now, efforts should be focused on making CGMs available to patients who will clearly benefit — ie, people with diabetes, especially those who are using insulin and those who are struggling to achieve desired levels of glucose control.”
Nicole Spartano, PhD, assistant professor of medicine in endocrinology, diabetes, nutrition and weight management at Boston University’s Chobanian & Avedisian School of Medicine in Massachusetts, agreed with this assessment.
“It is definitely too early to make recommendations for patients without diabetes based on their CGM data,” said Spartano, who also serves as the director of the Glucose Monitoring Station at the Framingham Heart Study in Framingham, Massachusetts. “We simply do not have enough follow-up data to tell us which CGM metrics are associated with higher risk for disease.”
Spartano served as the lead author of a recent study showing time spent in various CGM ranges in a large cohort of individuals without diabetes using the Dexcom G6 Pro model. In the future, she said the data may be used to establish reference ranges for clinicians and individuals.
“We are working on another paper surveying diabetologists and CGM experts about how they interpret CGM reports from individuals without diabetes,” she said in an interview. Although the data are not yet published, Spartano said, “we are finding that clinicians are currently very discordant in how they interpret these reports.”
Potential Benefits Right Now
Satish Garg, MD, director of the Adult Clinic at the Barbara Davis Center for Diabetes at the University of Colorado Anschutz Medical Campus, Aurora, and editor-in-chief of Diabetes Technology & Therapeutics, is convinced that glucose should be considered another vital sign, like blood pressure, pulse rate, respiration rate, and body temperature. Therefore, he sees the use of a CGM in people without diabetes as a way to build awareness and perhaps prompt behavior modification.
“Someone with an A1c of 4.9 on a normal day may notice that they’ve gained a little bit of weight, and if they use an OTC CGM and start seeing changes, it might help them to modulate their diet themselves, whether they see a dietitian or not,” Garg said.
He gave the example of “a natural behavioral change” occurring when someone using a CGM declines to eat a post-meal dessert after seeing their blood glucose had already risen to 170.
Wearing a CGM also has the potential to alert the user to high blood glucose, leading them to an earlier diagnosis of prediabetes or diabetes, Shichun Bao, MD, PhD, Diabetes Technology Program Leader at the Vanderbilt Eskind Diabetes Clinic of Vanderbilt University in Nashville, Tennessee, said in an interview. She has had cases where a family member of someone with diabetes used the patient’s fingerstick meter, found that their glucose was 280, and self-diagnosed with diabetes.
“It’s the same thing with the CGM,” she said. “If they somehow did not know they have diabetes and they wear a CGM and it shows their sugar is high, that will help them to know to see their provider to get a diagnosis, get treated, and track progression.”
Given the shortage of endocrinologists and long waits for appointments in the United States and elsewhere, it is very likely that primary care physicians will be the ones fielding questions from individuals without diabetes interested in purchasing an OTC CGM. Internist Douglas Paauw, MD, a professor at the University of Washington School of Medicine, Seattle, said in an interview that, for his practice, “the benefits outweigh some of the limitations.”
“I don’t really think somebody who doesn’t have diabetes needs to be using a CGM all the time or long term,” he said. “But I have used it in a few people without diabetes, and I think if someone can afford to use it for 2-4 weeks, especially if they’ve been gaining weight, then they can really recognize what happens to their bodies when they eat certain foods.”
Paauw added that CGMs are a more effective means of teaching his patients than them receiving a lecture from him on healthy eating. “There’s nothing like immediate feedback on what happens to your body to change behavior.”
Similarly, William Golden, medical director at Arkansas Medicaid and professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock, said in an interview that “it is difficult to justify coverage for CGMs on demand — but if people want to invest in their own devices and the technology motivates them to eat better and/or lose weight, then there are benefits to be had.”
Potential Downsides
Although it may seem simple to use an OTC CGM to measure blood glucose on the fly, in the real world it can take patients time to understand these devices, “especially the first day or so, when users are going to get false lows,” Bao said. “Clinicians need to tell them if you don’t feel like your sugar is low and the device says it’s low, whether they do or don’t have diabetes, they should do a fingerstick glucose test to confirm the low before rushing to take in sugar. On the other hand, if they drink a lot of juice, their sugar will go high. So, it can create problems and false results either way.”
Many factors affect glucose, she said. “When you’re sick, glucose can go high, and when you’re very sick, in the ICU, sometimes it can be low. It depends on the situation.” Bao noted that certain vitamins and drugs can also interfere with readings.
Bao doesn’t see value in having people without diabetes monitor their glucose continuously. “If they want to see what foods or exercise do to their body, they will probably benefit from a short trial to gain some insight; otherwise, they’re wasting money,” she said.
Another potential downside is that there’s no head-to-head comparison data with the approved devices, Garg said. “But it’s clear to us that Stelo’s range is very narrow, 70 to 200, whereas the Lingo ranges are pretty much full, from 40 to 400 or 55 to 400. So, we don’t know the accuracy of these sensors.”
Golden observed that for certain patients, CGMs may lead to psychological distress rather than providing a sense of control over their blood glucose levels.
“I have had a nondiabetic patient or two that obsessed about their blood sugars and a device would only magnify their anxiety/neurosis,” he said. “The bottom line is that it’s a tool for a balanced approach to health management, but the daily results must be kept in perspective!”
Educate Patients, Primary Care Physicians
To maximize potential benefits for patients without diabetes, clinicians need to be well trained in the use and interpretation of results from the devices, Bao said. They can then better educate their patients, including discussing with them possible pitfalls surrounding their use.
“For example, a patient may see that their blood glucose, as measured by a fingerstick, is 95, whereas the CGM says 140, and ask, ‘Which one do I trust?’ ”
This is where the patient can be educated about the difference between interstitial glucose, as measured by the CGM, and blood glucose, as measured by the fingerstick. Because it takes about 15 minutes for blood glucose to get to the interstitial tissue, there’s lag time, and the two measurements will differ.
“A discrepancy of 20% is totally acceptable for that reason,” Bao said.
She has also seen several examples where patients were misled by their CGM when its censor became dislodged.
“Sometimes when a sensor has moved, the patient may push it back in because they don’t want to throw it away. But it doesn’t work that way, and they end up with inaccurate readings.”
At a minimum, Bao added, clinicians and patients should read the package insert but also be aware that it doesn’t list everything that might go wrong or interfere with the device’s accuracy.
Manufacturers of OTC devices should be training primary care and family practice doctors in their use, given the expected “huge” influx of patients wanting to use them, according to Garg.
“If you are expecting endos or diabetes specialists to see these people, that’s never going to happen,” he said. “We have a big shortage of these specialists, so industry has to train these doctors. Patients will bring their doctor’s data, and the clinicians need to learn the basics of how to interpret the glucose values they see. Then they can treat these patients rather than shipping all of them to endos who likely are not available.”
Paauw agreed that CGM training should be directed largely toward primary care professionals, who can help their under-resourced endocrinologist colleagues from seeing an uptick in “the worried well.”
“The bottom line is that primary care professionals do need to understand the CGM,” he said. “They do need to get comfortable with it. They do need to come up with opinions on how to use it. The public’s going to be using it, and we need to be competent in it and use our subspecialists appropriately.”
Spartano received funding for an investigator-initiated research grant from Novo Nordisk unrelated to the cited CGM studies. Garg , Bao, Paauw, Golden, and Crandall declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Building an AI Army of Digital Twins to Fight Cancer
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
Smokeless Tobacco, Areca Nut Chewing Behind 1 in 3 Oral Cancers: IARC Report
“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.
Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.
“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.
According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.
More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.
The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.
Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
Limitations and Action Points
The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.
The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).
However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.
Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.
Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.
Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.
Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.
Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.
Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.
“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.
According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.
More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.
The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.
Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
Limitations and Action Points
The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.
The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).
However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.
Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.
Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.
Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.
Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.
Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.
Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.
“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.
According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.
More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.
The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.
Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
Limitations and Action Points
The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.
The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).
However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.
Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.
Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.
Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.
Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.
Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM THE LANCET ONCOLOGY
Doctors Caution Over Weight Loss Drug Link to Nurse’s Death
Doctors have urged caution in linking the weight loss drug tirzepatide to the death of a 58-year-old nurse from Scotland.
Susan McGowan, from North Lanarkshire, took two low-dose injections of tirzepatide (Mounjaro) over the course of about 2 weeks before her death in September.
BBC News reported that multiple organ failure, septic shock, and pancreatitis were listed on her death certificate as the immediate cause of death, with “the use of prescribed tirzepatide” recorded as a contributing factor.
McGowan worked as a nurse at University Hospital Monklands in Airdrie. A family member said that, apart from carrying a “bit of extra weight,” she had been otherwise healthy and was not taking any other medication.
It is understood that McGowan had sought medical advice before purchasing a prescription for tirzepatide through a registered UK pharmacy. However, days after administering a second injection, she went to A&E at Monklands with severe stomach pain and sickness. She died on September 4.
Expert Insights
Commenting to the Science Media Centre (SMC), Amanda Adler, MD, PhD, professor of diabetic medicine and health policy at the University of Oxford, described the nurse’s death as “sad” but said that “whether or not it was related to tirzepatide may be difficult to prove.” While tirzepatide can be associated with uncommon problems such as acute pancreatitis, “one can develop acute pancreatitis for many other reasons as well,” she said.
Naveed Sattar, MD, PhD, professor of metabolic medicine at the University of Glasgow, noted that data from multiple trials of tirzepatide, involving around 10,000 people living with diabetes or obesity, “do not suggest a higher risk of pancreatitis.” Furthermore, “the data seem to show acceptable safety thus far and a range of benefits including sizable average weight loss (near 20%), strong diabetes prevention, and considerable benefits in people living with sleep apnea,” he told the SMC.
Approved Based on Extensive Assessment
Tirzepatide, a GLP-1 receptor agonist, was approved for use as a weight loss aid in the United Kingdom in November last year by the Medicines and Healthcare products Regulatory Agency (MHRA). It lists nausea, diarrhea, and vomiting as the most common side effects, as well as hypoglycemia for patients with diabetes.
Available figures under the Yellow Card scheme up to 19 May 2024 show that there were 208 adverse drug reactions reported about tirzepatide this year, including 31 serious reactions and one suspected death of a man in his 60s.
In a statement, a spokesperson for the drug’s manufacturer, Eli Lilly, said, “Patient safety is Lilly’s top priority. We are committed to continually monitoring, evaluating, and reporting safety information for all Lilly medicines.
“Mounjaro (tirzepatide) was approved based on extensive assessment of the benefits and risks of the medicine, and we provide information about the benefits and risks of all our medicines to regulators around the world to ensure the latest information is available for prescribers. If anyone is experiencing side effects when taking any Lilly medicine, they should talk to their doctor or other healthcare professional.”
In October, the NHS submitted plans to the National Institute for Health and Care Excellence (NICE) for a phased rollout of tirzepatide in England that would initially prioritize patients with the greatest clinical need. The first phase would see the drug available to people with a body mass index of more than 40 kg/m2 who also suffer from at least three of the main weight-related health problems: hypertension, dyslipidemia, obstructive sleep apnea, and cardiovascular disease.
“Our sincere sympathies are with the family of individual concerned,” said Alison Cave, MHRA Chief Safety Officer.
“Patient safety is our top priority and no medicine would be approved unless it met our expected standards of safety, quality, and effectiveness. Our role is to continually monitor the safety of medicines during their use, such as GLP-1 RAs. We have robust, safety monitoring and surveillance systems in place for all healthcare products.
“New medicines, such as tirzepatide, are more intensively monitored to ensure that any new safety issues are identified promptly. We strongly encourage the reporting of all suspected reactions to newer medicines, which are denoted by an inverted Black Triangle symbol.
“On the basis of the current evidence the benefits of GLP-1 RAs outweigh the potential risks when used for the licensed indications. The decision to start, continue, or stop treatments should be made jointly by patients and their doctor, based on full consideration of the benefits and risks.”
She encouraged patients and healthcare professionals to continue reporting suspected side effects to GLP-1 RAs, such as tirzepatide, through the Yellow Card Scheme. “When a safety issue is confirmed, we always act promptly to inform patients and healthcare professionals and take appropriate steps to mitigate any identified risk.”
The Department of Health and Social Care declined to comment.
Adler disclosed being involved as an unpaid investigator on an Eli Lilly–funded trial for a different drug. Sattar has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Doctors have urged caution in linking the weight loss drug tirzepatide to the death of a 58-year-old nurse from Scotland.
Susan McGowan, from North Lanarkshire, took two low-dose injections of tirzepatide (Mounjaro) over the course of about 2 weeks before her death in September.
BBC News reported that multiple organ failure, septic shock, and pancreatitis were listed on her death certificate as the immediate cause of death, with “the use of prescribed tirzepatide” recorded as a contributing factor.
McGowan worked as a nurse at University Hospital Monklands in Airdrie. A family member said that, apart from carrying a “bit of extra weight,” she had been otherwise healthy and was not taking any other medication.
It is understood that McGowan had sought medical advice before purchasing a prescription for tirzepatide through a registered UK pharmacy. However, days after administering a second injection, she went to A&E at Monklands with severe stomach pain and sickness. She died on September 4.
Expert Insights
Commenting to the Science Media Centre (SMC), Amanda Adler, MD, PhD, professor of diabetic medicine and health policy at the University of Oxford, described the nurse’s death as “sad” but said that “whether or not it was related to tirzepatide may be difficult to prove.” While tirzepatide can be associated with uncommon problems such as acute pancreatitis, “one can develop acute pancreatitis for many other reasons as well,” she said.
Naveed Sattar, MD, PhD, professor of metabolic medicine at the University of Glasgow, noted that data from multiple trials of tirzepatide, involving around 10,000 people living with diabetes or obesity, “do not suggest a higher risk of pancreatitis.” Furthermore, “the data seem to show acceptable safety thus far and a range of benefits including sizable average weight loss (near 20%), strong diabetes prevention, and considerable benefits in people living with sleep apnea,” he told the SMC.
Approved Based on Extensive Assessment
Tirzepatide, a GLP-1 receptor agonist, was approved for use as a weight loss aid in the United Kingdom in November last year by the Medicines and Healthcare products Regulatory Agency (MHRA). It lists nausea, diarrhea, and vomiting as the most common side effects, as well as hypoglycemia for patients with diabetes.
Available figures under the Yellow Card scheme up to 19 May 2024 show that there were 208 adverse drug reactions reported about tirzepatide this year, including 31 serious reactions and one suspected death of a man in his 60s.
In a statement, a spokesperson for the drug’s manufacturer, Eli Lilly, said, “Patient safety is Lilly’s top priority. We are committed to continually monitoring, evaluating, and reporting safety information for all Lilly medicines.
“Mounjaro (tirzepatide) was approved based on extensive assessment of the benefits and risks of the medicine, and we provide information about the benefits and risks of all our medicines to regulators around the world to ensure the latest information is available for prescribers. If anyone is experiencing side effects when taking any Lilly medicine, they should talk to their doctor or other healthcare professional.”
In October, the NHS submitted plans to the National Institute for Health and Care Excellence (NICE) for a phased rollout of tirzepatide in England that would initially prioritize patients with the greatest clinical need. The first phase would see the drug available to people with a body mass index of more than 40 kg/m2 who also suffer from at least three of the main weight-related health problems: hypertension, dyslipidemia, obstructive sleep apnea, and cardiovascular disease.
“Our sincere sympathies are with the family of individual concerned,” said Alison Cave, MHRA Chief Safety Officer.
“Patient safety is our top priority and no medicine would be approved unless it met our expected standards of safety, quality, and effectiveness. Our role is to continually monitor the safety of medicines during their use, such as GLP-1 RAs. We have robust, safety monitoring and surveillance systems in place for all healthcare products.
“New medicines, such as tirzepatide, are more intensively monitored to ensure that any new safety issues are identified promptly. We strongly encourage the reporting of all suspected reactions to newer medicines, which are denoted by an inverted Black Triangle symbol.
“On the basis of the current evidence the benefits of GLP-1 RAs outweigh the potential risks when used for the licensed indications. The decision to start, continue, or stop treatments should be made jointly by patients and their doctor, based on full consideration of the benefits and risks.”
She encouraged patients and healthcare professionals to continue reporting suspected side effects to GLP-1 RAs, such as tirzepatide, through the Yellow Card Scheme. “When a safety issue is confirmed, we always act promptly to inform patients and healthcare professionals and take appropriate steps to mitigate any identified risk.”
The Department of Health and Social Care declined to comment.
Adler disclosed being involved as an unpaid investigator on an Eli Lilly–funded trial for a different drug. Sattar has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Doctors have urged caution in linking the weight loss drug tirzepatide to the death of a 58-year-old nurse from Scotland.
Susan McGowan, from North Lanarkshire, took two low-dose injections of tirzepatide (Mounjaro) over the course of about 2 weeks before her death in September.
BBC News reported that multiple organ failure, septic shock, and pancreatitis were listed on her death certificate as the immediate cause of death, with “the use of prescribed tirzepatide” recorded as a contributing factor.
McGowan worked as a nurse at University Hospital Monklands in Airdrie. A family member said that, apart from carrying a “bit of extra weight,” she had been otherwise healthy and was not taking any other medication.
It is understood that McGowan had sought medical advice before purchasing a prescription for tirzepatide through a registered UK pharmacy. However, days after administering a second injection, she went to A&E at Monklands with severe stomach pain and sickness. She died on September 4.
Expert Insights
Commenting to the Science Media Centre (SMC), Amanda Adler, MD, PhD, professor of diabetic medicine and health policy at the University of Oxford, described the nurse’s death as “sad” but said that “whether or not it was related to tirzepatide may be difficult to prove.” While tirzepatide can be associated with uncommon problems such as acute pancreatitis, “one can develop acute pancreatitis for many other reasons as well,” she said.
Naveed Sattar, MD, PhD, professor of metabolic medicine at the University of Glasgow, noted that data from multiple trials of tirzepatide, involving around 10,000 people living with diabetes or obesity, “do not suggest a higher risk of pancreatitis.” Furthermore, “the data seem to show acceptable safety thus far and a range of benefits including sizable average weight loss (near 20%), strong diabetes prevention, and considerable benefits in people living with sleep apnea,” he told the SMC.
Approved Based on Extensive Assessment
Tirzepatide, a GLP-1 receptor agonist, was approved for use as a weight loss aid in the United Kingdom in November last year by the Medicines and Healthcare products Regulatory Agency (MHRA). It lists nausea, diarrhea, and vomiting as the most common side effects, as well as hypoglycemia for patients with diabetes.
Available figures under the Yellow Card scheme up to 19 May 2024 show that there were 208 adverse drug reactions reported about tirzepatide this year, including 31 serious reactions and one suspected death of a man in his 60s.
In a statement, a spokesperson for the drug’s manufacturer, Eli Lilly, said, “Patient safety is Lilly’s top priority. We are committed to continually monitoring, evaluating, and reporting safety information for all Lilly medicines.
“Mounjaro (tirzepatide) was approved based on extensive assessment of the benefits and risks of the medicine, and we provide information about the benefits and risks of all our medicines to regulators around the world to ensure the latest information is available for prescribers. If anyone is experiencing side effects when taking any Lilly medicine, they should talk to their doctor or other healthcare professional.”
In October, the NHS submitted plans to the National Institute for Health and Care Excellence (NICE) for a phased rollout of tirzepatide in England that would initially prioritize patients with the greatest clinical need. The first phase would see the drug available to people with a body mass index of more than 40 kg/m2 who also suffer from at least three of the main weight-related health problems: hypertension, dyslipidemia, obstructive sleep apnea, and cardiovascular disease.
“Our sincere sympathies are with the family of individual concerned,” said Alison Cave, MHRA Chief Safety Officer.
“Patient safety is our top priority and no medicine would be approved unless it met our expected standards of safety, quality, and effectiveness. Our role is to continually monitor the safety of medicines during their use, such as GLP-1 RAs. We have robust, safety monitoring and surveillance systems in place for all healthcare products.
“New medicines, such as tirzepatide, are more intensively monitored to ensure that any new safety issues are identified promptly. We strongly encourage the reporting of all suspected reactions to newer medicines, which are denoted by an inverted Black Triangle symbol.
“On the basis of the current evidence the benefits of GLP-1 RAs outweigh the potential risks when used for the licensed indications. The decision to start, continue, or stop treatments should be made jointly by patients and their doctor, based on full consideration of the benefits and risks.”
She encouraged patients and healthcare professionals to continue reporting suspected side effects to GLP-1 RAs, such as tirzepatide, through the Yellow Card Scheme. “When a safety issue is confirmed, we always act promptly to inform patients and healthcare professionals and take appropriate steps to mitigate any identified risk.”
The Department of Health and Social Care declined to comment.
Adler disclosed being involved as an unpaid investigator on an Eli Lilly–funded trial for a different drug. Sattar has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Vitamin K Supplementation Reduces Nocturnal Leg Cramps in Older Adults
TOPLINE:
Vitamin K supplementation significantly reduced the frequency, intensity, and duration of nocturnal leg cramps in older adults. No adverse events related to vitamin K were identified.
METHODOLOGY:
- Researchers conducted a multicenter, double-blind, placebo-controlled randomized clinical trial in China from September 2022 to December 2023.
- A total of 199 participants aged ≥ 65 years with at least two documented episodes of nocturnal leg cramps during a 2-week screening period were included.
- Participants were randomized in a 1:1 ratio to receive either 180 μg of vitamin K (menaquinone 7) or a placebo daily for 8 weeks.
- The primary outcome was the mean number of nocturnal leg cramps per week, while secondary outcomes were the duration and severity of muscle cramps.
- The ethics committees of Third People’s Hospital of Chengdu and Affiliated Hospital of North Sichuan Medical College approved the study, and all participants provided written informed consent.
TAKEAWAY:
- Vitamin K group experienced a significant reduction in the mean weekly frequency of cramps (mean difference, 2.60 [SD, 0.81] to 0.96 [SD, 1.41]) compared with the placebo group, which maintained a mean weekly frequency of 3.63 (SD, 2.20) (P < .001).
- The severity of nocturnal leg cramps decreased more in the vitamin K group (mean difference, −2.55 [SD, 2.12] points) than in the placebo group (mean difference, −1.24 [SD, 1.16] points).
- The duration of nocturnal leg cramps also decreased more in the vitamin K group (mean difference, −0.90 [SD, 0.88] minutes) than in the placebo group (mean difference, −0.32 [SD, 0.78] minutes).
- No adverse events related to vitamin K use were identified, indicating a good safety profile for the supplementation.
IN PRACTICE:
“Given the generally benign characteristics of NLCs, treatment modality must be both effective and safe, thus minimizing the risk of iatrogenic harm,” the study authors wrote.
SOURCE:
This study was led by Jing Tan, MD, the Third People’s Hospital of Chengdu in Chengdu, China. It was published online on October 28 in JAMA Internal Medicine.
LIMITATIONS:
This study did not investigate the quality of life or sleep, which could have provided additional insights into the impact of vitamin K on nocturnal leg cramps. The relatively mild nature of nocturnal leg cramps experienced by the participants may limit the generalizability of the findings to populations with more severe symptoms.
DISCLOSURES:
This study was supported by grants from China Health Promotion Foundation and the Third People’s Hospital of Chengdu Scientific Research Project. Tan disclosed receiving personal fees from BeiGene, AbbVie, Pfizer, Xian Janssen Pharmaceutical, and Takeda Pharmaceutical outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Vitamin K supplementation significantly reduced the frequency, intensity, and duration of nocturnal leg cramps in older adults. No adverse events related to vitamin K were identified.
METHODOLOGY:
- Researchers conducted a multicenter, double-blind, placebo-controlled randomized clinical trial in China from September 2022 to December 2023.
- A total of 199 participants aged ≥ 65 years with at least two documented episodes of nocturnal leg cramps during a 2-week screening period were included.
- Participants were randomized in a 1:1 ratio to receive either 180 μg of vitamin K (menaquinone 7) or a placebo daily for 8 weeks.
- The primary outcome was the mean number of nocturnal leg cramps per week, while secondary outcomes were the duration and severity of muscle cramps.
- The ethics committees of Third People’s Hospital of Chengdu and Affiliated Hospital of North Sichuan Medical College approved the study, and all participants provided written informed consent.
TAKEAWAY:
- Vitamin K group experienced a significant reduction in the mean weekly frequency of cramps (mean difference, 2.60 [SD, 0.81] to 0.96 [SD, 1.41]) compared with the placebo group, which maintained a mean weekly frequency of 3.63 (SD, 2.20) (P < .001).
- The severity of nocturnal leg cramps decreased more in the vitamin K group (mean difference, −2.55 [SD, 2.12] points) than in the placebo group (mean difference, −1.24 [SD, 1.16] points).
- The duration of nocturnal leg cramps also decreased more in the vitamin K group (mean difference, −0.90 [SD, 0.88] minutes) than in the placebo group (mean difference, −0.32 [SD, 0.78] minutes).
- No adverse events related to vitamin K use were identified, indicating a good safety profile for the supplementation.
IN PRACTICE:
“Given the generally benign characteristics of NLCs, treatment modality must be both effective and safe, thus minimizing the risk of iatrogenic harm,” the study authors wrote.
SOURCE:
This study was led by Jing Tan, MD, the Third People’s Hospital of Chengdu in Chengdu, China. It was published online on October 28 in JAMA Internal Medicine.
LIMITATIONS:
This study did not investigate the quality of life or sleep, which could have provided additional insights into the impact of vitamin K on nocturnal leg cramps. The relatively mild nature of nocturnal leg cramps experienced by the participants may limit the generalizability of the findings to populations with more severe symptoms.
DISCLOSURES:
This study was supported by grants from China Health Promotion Foundation and the Third People’s Hospital of Chengdu Scientific Research Project. Tan disclosed receiving personal fees from BeiGene, AbbVie, Pfizer, Xian Janssen Pharmaceutical, and Takeda Pharmaceutical outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Vitamin K supplementation significantly reduced the frequency, intensity, and duration of nocturnal leg cramps in older adults. No adverse events related to vitamin K were identified.
METHODOLOGY:
- Researchers conducted a multicenter, double-blind, placebo-controlled randomized clinical trial in China from September 2022 to December 2023.
- A total of 199 participants aged ≥ 65 years with at least two documented episodes of nocturnal leg cramps during a 2-week screening period were included.
- Participants were randomized in a 1:1 ratio to receive either 180 μg of vitamin K (menaquinone 7) or a placebo daily for 8 weeks.
- The primary outcome was the mean number of nocturnal leg cramps per week, while secondary outcomes were the duration and severity of muscle cramps.
- The ethics committees of Third People’s Hospital of Chengdu and Affiliated Hospital of North Sichuan Medical College approved the study, and all participants provided written informed consent.
TAKEAWAY:
- Vitamin K group experienced a significant reduction in the mean weekly frequency of cramps (mean difference, 2.60 [SD, 0.81] to 0.96 [SD, 1.41]) compared with the placebo group, which maintained a mean weekly frequency of 3.63 (SD, 2.20) (P < .001).
- The severity of nocturnal leg cramps decreased more in the vitamin K group (mean difference, −2.55 [SD, 2.12] points) than in the placebo group (mean difference, −1.24 [SD, 1.16] points).
- The duration of nocturnal leg cramps also decreased more in the vitamin K group (mean difference, −0.90 [SD, 0.88] minutes) than in the placebo group (mean difference, −0.32 [SD, 0.78] minutes).
- No adverse events related to vitamin K use were identified, indicating a good safety profile for the supplementation.
IN PRACTICE:
“Given the generally benign characteristics of NLCs, treatment modality must be both effective and safe, thus minimizing the risk of iatrogenic harm,” the study authors wrote.
SOURCE:
This study was led by Jing Tan, MD, the Third People’s Hospital of Chengdu in Chengdu, China. It was published online on October 28 in JAMA Internal Medicine.
LIMITATIONS:
This study did not investigate the quality of life or sleep, which could have provided additional insights into the impact of vitamin K on nocturnal leg cramps. The relatively mild nature of nocturnal leg cramps experienced by the participants may limit the generalizability of the findings to populations with more severe symptoms.
DISCLOSURES:
This study was supported by grants from China Health Promotion Foundation and the Third People’s Hospital of Chengdu Scientific Research Project. Tan disclosed receiving personal fees from BeiGene, AbbVie, Pfizer, Xian Janssen Pharmaceutical, and Takeda Pharmaceutical outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.