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Proclivity ID
18818001
Unpublish
Specialty Focus
Mental Health
Vaccines
Addiction Medicine
Geriatrics
Negative Keywords
gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
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rumprammerer
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rums
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ruskiing
ruskily
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scaged
scager
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scaging
scagly
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scantily
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scantilyer
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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
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scroting
scrotly
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scrotumed
scrotumer
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scrotuming
scrotumly
scrotums
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scruded
scruder
scrudes
scruding
scrudly
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scumer
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scuming
scumly
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seamanly
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seamener
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seamenly
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seduceer
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seduceing
seducely
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semened
semener
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semening
semenly
semens
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shamedamees
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shamedamely
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shit
shite
shiteater
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shiteaterer
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shiteaterly
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shites
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shitheader
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shithousely
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shitly
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shitted
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shittes
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shittly
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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
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skager
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skaging
skagly
skags
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skanker
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skanking
skankly
skanks
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slaveed
slaveer
slavees
slaveing
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spicer
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spicker
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spickly
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spoogees
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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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stiffyes
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stiffyly
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stonedly
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stupidly
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suckes
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suckinger
suckinges
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suckingly
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suckly
sucks
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sumofabiatching
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tarded
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tardes
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tawdryes
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tawdryly
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teabagginger
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teabaggingly
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terded
terder
terdes
terding
terdly
terds
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testee
testeed
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testeely
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testees
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testely
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testesly
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testiclely
testicles
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testised
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testises
testising
testisly
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thruster
thrustes
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thrustly
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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
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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
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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
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twatly
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twatser
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uzied
uzier
uzies
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uzily
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vaged
vager
vages
vaging
vagly
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valiumed
valiumer
valiumes
valiuming
valiumly
valiums
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virgined
virginer
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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
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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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wanking
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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weenie
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
wetbacks
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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whorealiciousing
whorealiciously
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whoreded
whoreder
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whoreding
whoredly
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whorefaceed
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whorefaceing
whorefacely
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whorehopper
whorehoppered
whorehopperer
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whorehoppering
whorehopperly
whorehoppers
whorehouse
whorehouseed
whorehouseer
whorehousees
whorehouseing
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whoreing
whorely
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whoresed
whoreser
whoreses
whoresing
whoresly
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whoringing
whoringly
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wigger
wiggered
wiggerer
wiggeres
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wiggerly
wiggers
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woodyed
woodyer
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woodying
woodyly
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woped
woper
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woping
woply
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wtf
wtfed
wtfer
wtfes
wtfing
wtfly
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xxx
xxxed
xxxer
xxxes
xxxing
xxxly
xxxs
yeasty
yeastyed
yeastyer
yeastyes
yeastying
yeastyly
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yobbo
yobboed
yobboer
yobboes
yobboing
yobboly
yobbos
zoophile
zoophileed
zoophileer
zoophilees
zoophileing
zoophilely
zoophiles
anal
ass
ass lick
balls
ballsac
bisexual
bleach
causas
cheap
cost of miracles
cunt
display network stats
fart
fda and death
fda AND warn
fda AND warning
fda AND warns
feom
fuck
gfc
humira AND expensive
illegal
madvocate
masturbation
nuccitelli
overdose
porn
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snort
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
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Patient Navigators for Serious Illnesses Can Now Bill Under New Medicare Codes

Article Type
Changed
Tue, 09/24/2024 - 13:12

 

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.

 

Thyme Care
Dr. Samyukta Mullangi

“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.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



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.

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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.

 

Thyme Care
Dr. Samyukta Mullangi

“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.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



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.

 

Thyme Care
Dr. Samyukta Mullangi

“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.

Journal of Oncology Navigation & Survivorship
Sharon Gentry



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.

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New ‘Touchless’ Blood Pressure Screening Tech: How It Works

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When a patient signs on to a telehealth portal, there’s little more a provider can do than ask questions. But a new artificial intelligence (AI) technology could allow providers to get feedback about the patient’s blood pressure and diabetes risk just from a video call or a smartphone app.

Researchers at the University of Tokyo in Japan are using AI to determine whether people might have high blood pressure or diabetes based on video data collected with a special sensor. 

The technology relies on photoplethysmography (PPG), which measures changes in blood volume by detecting the amount of light absorbed by blood just below the skin. 

This technology is already used for things like finger pulse oximetry to determine oxygen saturation and heart rate. Wearable devices like Apple Watches and Fitbits also use PPG technologies to detect heart rate and atrial fibrillation.

“If we could detect and accurately measure your blood pressure, heart rate, and oxygen saturation non-invasively that would be fantastic,” said Eugene Yang, MD, professor of medicine in the division of cardiology at the University of Washington School of Medicine in Seattle who was not involved in the study.

 

How Does PPG Work — and Is This New Tech Accurate?

Using PPG, “you’re detecting these small, little blood vessels that sit underneath the surface of your skin,” explained Yang.

“Since both hypertension and diabetes are diseases that damage blood vessels, we thought these diseases might affect blood flow and pulse wave transit times,” said Ryoko Uchida, a project researcher in the cardiology department at the University of Tokyo and one of the leaders of the study.

PPG devices primarily use green light to detect blood flow, as hemoglobin, the oxygen-carrying molecule in blood, absorbs green light most effectively, Yang said. “So, if you extract and remove all the other channels of light and only focus on the green channel, then that’s when you’ll be able to potentially see blood flow and pulsatile blood flow activity,” he noted.

The University of Tokyo researchers used remote or contactless PPG, which requires a short video recording of someone’s face and palms, as the person holds as still as possible. A special sensor collects the video and detects only certain wavelengths of light. Then the researchers developed an AI algorithm to extract data from participants’ skin, such as changes in pulse transit time — the time it takes for the pulse to travel from the palm to the face.

To correlate the video algorithm to blood pressure and diabetes risk, the researchers measured blood participants’ pressure with a continuous sphygmomanometer (an automatic blood pressure cuff) at the same time as they collected the video. They also did a blood A1c test to detect diabetes.

So far, they’ve tested their video algorithm on 215 people. The algorithm applied to a 30-second video was 86% accurate in detecting if blood pressure was above normal, and a 5-second video was 81% accurate in detecting higher blood pressure.

Compared with using hemoglobin A1c blood test results to screen for diabetes, the video algorithm was 75% accurate in identifying people who had subtle blood changes that correlated to diabetes.

“Most of this focus has been on wearable devices, patches, rings, wrist devices,” Yang said, “the facial video stuff is great because you can imagine that there are other ways of applying it.”

Yang, who is also doing research on facial video processing, pointed out it could be helpful not only in telehealth visits, but also for patients in the hospital with highly contagious diseases who need to be in isolation, or just for people using their smartphones. 

“People are tied to their smartphones, so you could imagine that that would be great as a way for people to have awareness about their blood pressure or their diabetes status,” Yang noted.

 

More Work to Do

The study has a few caveats. The special sensor they used in this study isn’t yet integrated into smartphone cameras or other common video recording devices. But Uchida is hopeful that it could be mass-produced and inexpensive to someday add.

Also, the study was done in a Japanese population, and lighter skin may be easier to capture changes in blood flow, Uchida noted. Pulse oximeters, which use the same technology, tend to overestimate blood oxygen in people with darker skin tones.

“It is necessary to test whether the same results are obtained in a variety of subjects other than Japanese and Asians,” Uchida said, in addition to validating the tool with more participants.

The study has also not yet undergone peer review.

And Yang pointed out that this new AI technology provides more of a screening tool to predict who is at high risk for high blood pressure or diabetes, rather than precise measurements for either disease.

There are already some devices that claim to measure blood pressure using PPG technology, like blood pressure monitoring watches. But Yang warns that these kinds of devices aren’t validated, meaning we don’t really know how well they work.

One difficulty in getting any kind of PPG blood pressure monitoring device to market is that the organizations involved in setting medical device standards (like the International Organization for Standards) doesn’t yet have a validation standard for this technology, Yang said, so there’s really no way to consistently verify the technology’s accuracy.

“I am optimistic that we are capable of figuring out how to validate these things. I just think we have so many things we have to iron out before that happens,” Yang explained, noting that it will be at least 3 years before a remote blood monitoring system is widely available.

A version of this article first appeared on Medscape.com.

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When a patient signs on to a telehealth portal, there’s little more a provider can do than ask questions. But a new artificial intelligence (AI) technology could allow providers to get feedback about the patient’s blood pressure and diabetes risk just from a video call or a smartphone app.

Researchers at the University of Tokyo in Japan are using AI to determine whether people might have high blood pressure or diabetes based on video data collected with a special sensor. 

The technology relies on photoplethysmography (PPG), which measures changes in blood volume by detecting the amount of light absorbed by blood just below the skin. 

This technology is already used for things like finger pulse oximetry to determine oxygen saturation and heart rate. Wearable devices like Apple Watches and Fitbits also use PPG technologies to detect heart rate and atrial fibrillation.

“If we could detect and accurately measure your blood pressure, heart rate, and oxygen saturation non-invasively that would be fantastic,” said Eugene Yang, MD, professor of medicine in the division of cardiology at the University of Washington School of Medicine in Seattle who was not involved in the study.

 

How Does PPG Work — and Is This New Tech Accurate?

Using PPG, “you’re detecting these small, little blood vessels that sit underneath the surface of your skin,” explained Yang.

“Since both hypertension and diabetes are diseases that damage blood vessels, we thought these diseases might affect blood flow and pulse wave transit times,” said Ryoko Uchida, a project researcher in the cardiology department at the University of Tokyo and one of the leaders of the study.

PPG devices primarily use green light to detect blood flow, as hemoglobin, the oxygen-carrying molecule in blood, absorbs green light most effectively, Yang said. “So, if you extract and remove all the other channels of light and only focus on the green channel, then that’s when you’ll be able to potentially see blood flow and pulsatile blood flow activity,” he noted.

The University of Tokyo researchers used remote or contactless PPG, which requires a short video recording of someone’s face and palms, as the person holds as still as possible. A special sensor collects the video and detects only certain wavelengths of light. Then the researchers developed an AI algorithm to extract data from participants’ skin, such as changes in pulse transit time — the time it takes for the pulse to travel from the palm to the face.

To correlate the video algorithm to blood pressure and diabetes risk, the researchers measured blood participants’ pressure with a continuous sphygmomanometer (an automatic blood pressure cuff) at the same time as they collected the video. They also did a blood A1c test to detect diabetes.

So far, they’ve tested their video algorithm on 215 people. The algorithm applied to a 30-second video was 86% accurate in detecting if blood pressure was above normal, and a 5-second video was 81% accurate in detecting higher blood pressure.

Compared with using hemoglobin A1c blood test results to screen for diabetes, the video algorithm was 75% accurate in identifying people who had subtle blood changes that correlated to diabetes.

“Most of this focus has been on wearable devices, patches, rings, wrist devices,” Yang said, “the facial video stuff is great because you can imagine that there are other ways of applying it.”

Yang, who is also doing research on facial video processing, pointed out it could be helpful not only in telehealth visits, but also for patients in the hospital with highly contagious diseases who need to be in isolation, or just for people using their smartphones. 

“People are tied to their smartphones, so you could imagine that that would be great as a way for people to have awareness about their blood pressure or their diabetes status,” Yang noted.

 

More Work to Do

The study has a few caveats. The special sensor they used in this study isn’t yet integrated into smartphone cameras or other common video recording devices. But Uchida is hopeful that it could be mass-produced and inexpensive to someday add.

Also, the study was done in a Japanese population, and lighter skin may be easier to capture changes in blood flow, Uchida noted. Pulse oximeters, which use the same technology, tend to overestimate blood oxygen in people with darker skin tones.

“It is necessary to test whether the same results are obtained in a variety of subjects other than Japanese and Asians,” Uchida said, in addition to validating the tool with more participants.

The study has also not yet undergone peer review.

And Yang pointed out that this new AI technology provides more of a screening tool to predict who is at high risk for high blood pressure or diabetes, rather than precise measurements for either disease.

There are already some devices that claim to measure blood pressure using PPG technology, like blood pressure monitoring watches. But Yang warns that these kinds of devices aren’t validated, meaning we don’t really know how well they work.

One difficulty in getting any kind of PPG blood pressure monitoring device to market is that the organizations involved in setting medical device standards (like the International Organization for Standards) doesn’t yet have a validation standard for this technology, Yang said, so there’s really no way to consistently verify the technology’s accuracy.

“I am optimistic that we are capable of figuring out how to validate these things. I just think we have so many things we have to iron out before that happens,” Yang explained, noting that it will be at least 3 years before a remote blood monitoring system is widely available.

A version of this article first appeared on Medscape.com.

When a patient signs on to a telehealth portal, there’s little more a provider can do than ask questions. But a new artificial intelligence (AI) technology could allow providers to get feedback about the patient’s blood pressure and diabetes risk just from a video call or a smartphone app.

Researchers at the University of Tokyo in Japan are using AI to determine whether people might have high blood pressure or diabetes based on video data collected with a special sensor. 

The technology relies on photoplethysmography (PPG), which measures changes in blood volume by detecting the amount of light absorbed by blood just below the skin. 

This technology is already used for things like finger pulse oximetry to determine oxygen saturation and heart rate. Wearable devices like Apple Watches and Fitbits also use PPG technologies to detect heart rate and atrial fibrillation.

“If we could detect and accurately measure your blood pressure, heart rate, and oxygen saturation non-invasively that would be fantastic,” said Eugene Yang, MD, professor of medicine in the division of cardiology at the University of Washington School of Medicine in Seattle who was not involved in the study.

 

How Does PPG Work — and Is This New Tech Accurate?

Using PPG, “you’re detecting these small, little blood vessels that sit underneath the surface of your skin,” explained Yang.

“Since both hypertension and diabetes are diseases that damage blood vessels, we thought these diseases might affect blood flow and pulse wave transit times,” said Ryoko Uchida, a project researcher in the cardiology department at the University of Tokyo and one of the leaders of the study.

PPG devices primarily use green light to detect blood flow, as hemoglobin, the oxygen-carrying molecule in blood, absorbs green light most effectively, Yang said. “So, if you extract and remove all the other channels of light and only focus on the green channel, then that’s when you’ll be able to potentially see blood flow and pulsatile blood flow activity,” he noted.

The University of Tokyo researchers used remote or contactless PPG, which requires a short video recording of someone’s face and palms, as the person holds as still as possible. A special sensor collects the video and detects only certain wavelengths of light. Then the researchers developed an AI algorithm to extract data from participants’ skin, such as changes in pulse transit time — the time it takes for the pulse to travel from the palm to the face.

To correlate the video algorithm to blood pressure and diabetes risk, the researchers measured blood participants’ pressure with a continuous sphygmomanometer (an automatic blood pressure cuff) at the same time as they collected the video. They also did a blood A1c test to detect diabetes.

So far, they’ve tested their video algorithm on 215 people. The algorithm applied to a 30-second video was 86% accurate in detecting if blood pressure was above normal, and a 5-second video was 81% accurate in detecting higher blood pressure.

Compared with using hemoglobin A1c blood test results to screen for diabetes, the video algorithm was 75% accurate in identifying people who had subtle blood changes that correlated to diabetes.

“Most of this focus has been on wearable devices, patches, rings, wrist devices,” Yang said, “the facial video stuff is great because you can imagine that there are other ways of applying it.”

Yang, who is also doing research on facial video processing, pointed out it could be helpful not only in telehealth visits, but also for patients in the hospital with highly contagious diseases who need to be in isolation, or just for people using their smartphones. 

“People are tied to their smartphones, so you could imagine that that would be great as a way for people to have awareness about their blood pressure or their diabetes status,” Yang noted.

 

More Work to Do

The study has a few caveats. The special sensor they used in this study isn’t yet integrated into smartphone cameras or other common video recording devices. But Uchida is hopeful that it could be mass-produced and inexpensive to someday add.

Also, the study was done in a Japanese population, and lighter skin may be easier to capture changes in blood flow, Uchida noted. Pulse oximeters, which use the same technology, tend to overestimate blood oxygen in people with darker skin tones.

“It is necessary to test whether the same results are obtained in a variety of subjects other than Japanese and Asians,” Uchida said, in addition to validating the tool with more participants.

The study has also not yet undergone peer review.

And Yang pointed out that this new AI technology provides more of a screening tool to predict who is at high risk for high blood pressure or diabetes, rather than precise measurements for either disease.

There are already some devices that claim to measure blood pressure using PPG technology, like blood pressure monitoring watches. But Yang warns that these kinds of devices aren’t validated, meaning we don’t really know how well they work.

One difficulty in getting any kind of PPG blood pressure monitoring device to market is that the organizations involved in setting medical device standards (like the International Organization for Standards) doesn’t yet have a validation standard for this technology, Yang said, so there’s really no way to consistently verify the technology’s accuracy.

“I am optimistic that we are capable of figuring out how to validate these things. I just think we have so many things we have to iron out before that happens,” Yang explained, noting that it will be at least 3 years before a remote blood monitoring system is widely available.

A version of this article first appeared on Medscape.com.

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What To Do With Lipoprotein(a)?

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Case: 45-year-old woman comes to clinic and requests lipoprotein(a) [Lp(a)] testing. She has a family history of early coronary disease (mother age 50, sister age 48) and has hypertension with home blood pressure readings of 130-140/70-75. She had a lipid panel checked last year which showed a total cholesterol of 210 mg/dL, LDL 145 mg/dL, HDL 45 mg/dL, and triglycerides of 100 mg/dL. She does not smoke and is currently taking irbesartan, chlorthalidone, sertraline, a multivitamin, and vitamin D.

What do you recommend?

There has been a great deal of media attention on testing for Lp(a). Many of my patients are requesting testing although many of them do not need it. This patient is an exception. I think Lp(a) testing would help inform her medical care. She has a family history of early coronary disease in her mother and sister, but her own lipid profile is not worrisome.

Her 10-year cardiovascular disease risk is 2%. The cardiac risk calculator does not incorporate family history; I think this is a situation where testing for Lp(a)(as well as apolipoprotein B) can be helpful. If her Lp(a) is elevated, it helps reassess her risk and that information would be helpful in targeting aggressive interventions for other CV risk factors, including optimal blood pressure control. In her case, pushing for a goal systolic blood pressure below 120 mm Hg and making sure she is doing regular exercise and eating a heart-healthy diet. The current consensus statement on Lp(a) recommends that patients with elevated levels have aggressive lifestyle and cardiovascular risk management.1

 

Dr. Douglas S. Paauw

Currently, there are no medical treatments available for high Lp(a) for primary prevention. Apheresis has been approved by the US Food and Drug Administration (FDA) for patients with familial hyperlipidemia who have LDL ≥ 100 mg/dL, Lp(a) ≥ 60 mg/dL, and coronary or other artery disease. 

PCSK9 inhibitors have shown a reduction in major cardiovascular events in patients who have established coronary artery disease and high Lp(a) levels, albeit with limited data. Unlike statins, which increase Lp(a) levels, PCSK9 inhibitors reduce Lp(a) levels.2 There are promising early results in a phase 2 trial of the oral drug muvalaplin lowering Lp(a) levels by up to 85% for the highest dose, but there are no peer-reviewed articles confirming these results and no outcome trials at this time.

In patients who are already recognized as high risk, especially those with established coronary artery disease, measuring Lp(a) levels offer little benefit. These patients should already be receiving aggressive medical therapy to reach blood pressure targets if hypertensive, maximal lifestyle modifications, and statin therapy. 

If these patients need more therapy because of continued coronary events, despite maximal conventional medical therapy, then adding a PCSK9 inhibitor would be appropriate whether or not a patient has a high Lp(a) level. Once Lp(a) targeted therapies are available and show clinical benefit, then the role of Lp(a) measurement and treatment in this population will be clearer.

Pearl: Most patients do not need Lp(a) testing. There are no FDA-approved treatments for high Lp(a) levels.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Kronenberg F et al. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: A European Atherosclerosis Society consensus statement. Eur Heart J. 2022;43:3925-46.

2. Ruscica M et al. Lipoprotein(a) and PCSK9 inhibition: Clinical evidence Eur Heart J Suppl 2020;Nov 18(Suppl L):L53–L56.

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Case: 45-year-old woman comes to clinic and requests lipoprotein(a) [Lp(a)] testing. She has a family history of early coronary disease (mother age 50, sister age 48) and has hypertension with home blood pressure readings of 130-140/70-75. She had a lipid panel checked last year which showed a total cholesterol of 210 mg/dL, LDL 145 mg/dL, HDL 45 mg/dL, and triglycerides of 100 mg/dL. She does not smoke and is currently taking irbesartan, chlorthalidone, sertraline, a multivitamin, and vitamin D.

What do you recommend?

There has been a great deal of media attention on testing for Lp(a). Many of my patients are requesting testing although many of them do not need it. This patient is an exception. I think Lp(a) testing would help inform her medical care. She has a family history of early coronary disease in her mother and sister, but her own lipid profile is not worrisome.

Her 10-year cardiovascular disease risk is 2%. The cardiac risk calculator does not incorporate family history; I think this is a situation where testing for Lp(a)(as well as apolipoprotein B) can be helpful. If her Lp(a) is elevated, it helps reassess her risk and that information would be helpful in targeting aggressive interventions for other CV risk factors, including optimal blood pressure control. In her case, pushing for a goal systolic blood pressure below 120 mm Hg and making sure she is doing regular exercise and eating a heart-healthy diet. The current consensus statement on Lp(a) recommends that patients with elevated levels have aggressive lifestyle and cardiovascular risk management.1

 

Dr. Douglas S. Paauw

Currently, there are no medical treatments available for high Lp(a) for primary prevention. Apheresis has been approved by the US Food and Drug Administration (FDA) for patients with familial hyperlipidemia who have LDL ≥ 100 mg/dL, Lp(a) ≥ 60 mg/dL, and coronary or other artery disease. 

PCSK9 inhibitors have shown a reduction in major cardiovascular events in patients who have established coronary artery disease and high Lp(a) levels, albeit with limited data. Unlike statins, which increase Lp(a) levels, PCSK9 inhibitors reduce Lp(a) levels.2 There are promising early results in a phase 2 trial of the oral drug muvalaplin lowering Lp(a) levels by up to 85% for the highest dose, but there are no peer-reviewed articles confirming these results and no outcome trials at this time.

In patients who are already recognized as high risk, especially those with established coronary artery disease, measuring Lp(a) levels offer little benefit. These patients should already be receiving aggressive medical therapy to reach blood pressure targets if hypertensive, maximal lifestyle modifications, and statin therapy. 

If these patients need more therapy because of continued coronary events, despite maximal conventional medical therapy, then adding a PCSK9 inhibitor would be appropriate whether or not a patient has a high Lp(a) level. Once Lp(a) targeted therapies are available and show clinical benefit, then the role of Lp(a) measurement and treatment in this population will be clearer.

Pearl: Most patients do not need Lp(a) testing. There are no FDA-approved treatments for high Lp(a) levels.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Kronenberg F et al. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: A European Atherosclerosis Society consensus statement. Eur Heart J. 2022;43:3925-46.

2. Ruscica M et al. Lipoprotein(a) and PCSK9 inhibition: Clinical evidence Eur Heart J Suppl 2020;Nov 18(Suppl L):L53–L56.

Case: 45-year-old woman comes to clinic and requests lipoprotein(a) [Lp(a)] testing. She has a family history of early coronary disease (mother age 50, sister age 48) and has hypertension with home blood pressure readings of 130-140/70-75. She had a lipid panel checked last year which showed a total cholesterol of 210 mg/dL, LDL 145 mg/dL, HDL 45 mg/dL, and triglycerides of 100 mg/dL. She does not smoke and is currently taking irbesartan, chlorthalidone, sertraline, a multivitamin, and vitamin D.

What do you recommend?

There has been a great deal of media attention on testing for Lp(a). Many of my patients are requesting testing although many of them do not need it. This patient is an exception. I think Lp(a) testing would help inform her medical care. She has a family history of early coronary disease in her mother and sister, but her own lipid profile is not worrisome.

Her 10-year cardiovascular disease risk is 2%. The cardiac risk calculator does not incorporate family history; I think this is a situation where testing for Lp(a)(as well as apolipoprotein B) can be helpful. If her Lp(a) is elevated, it helps reassess her risk and that information would be helpful in targeting aggressive interventions for other CV risk factors, including optimal blood pressure control. In her case, pushing for a goal systolic blood pressure below 120 mm Hg and making sure she is doing regular exercise and eating a heart-healthy diet. The current consensus statement on Lp(a) recommends that patients with elevated levels have aggressive lifestyle and cardiovascular risk management.1

 

Dr. Douglas S. Paauw

Currently, there are no medical treatments available for high Lp(a) for primary prevention. Apheresis has been approved by the US Food and Drug Administration (FDA) for patients with familial hyperlipidemia who have LDL ≥ 100 mg/dL, Lp(a) ≥ 60 mg/dL, and coronary or other artery disease. 

PCSK9 inhibitors have shown a reduction in major cardiovascular events in patients who have established coronary artery disease and high Lp(a) levels, albeit with limited data. Unlike statins, which increase Lp(a) levels, PCSK9 inhibitors reduce Lp(a) levels.2 There are promising early results in a phase 2 trial of the oral drug muvalaplin lowering Lp(a) levels by up to 85% for the highest dose, but there are no peer-reviewed articles confirming these results and no outcome trials at this time.

In patients who are already recognized as high risk, especially those with established coronary artery disease, measuring Lp(a) levels offer little benefit. These patients should already be receiving aggressive medical therapy to reach blood pressure targets if hypertensive, maximal lifestyle modifications, and statin therapy. 

If these patients need more therapy because of continued coronary events, despite maximal conventional medical therapy, then adding a PCSK9 inhibitor would be appropriate whether or not a patient has a high Lp(a) level. Once Lp(a) targeted therapies are available and show clinical benefit, then the role of Lp(a) measurement and treatment in this population will be clearer.

Pearl: Most patients do not need Lp(a) testing. There are no FDA-approved treatments for high Lp(a) levels.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.

References

1. Kronenberg F et al. Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: A European Atherosclerosis Society consensus statement. Eur Heart J. 2022;43:3925-46.

2. Ruscica M et al. Lipoprotein(a) and PCSK9 inhibition: Clinical evidence Eur Heart J Suppl 2020;Nov 18(Suppl L):L53–L56.

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Winter Depression: How to Make the ‘SAD’ Diagnosis

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’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

  • Loss of energy
  • Hypersomnia
  • A craving for carbohydrates
  • Overeating
  • Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

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’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

  • Loss of energy
  • Hypersomnia
  • A craving for carbohydrates
  • Overeating
  • Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

’Tis the season for recognizing seasonal affective disorder (SAD). Just don’t expect to find SAD in diagnostic handbooks.

As a memorable term, SAD “stuck in the general public, and to some extent among health professionals,” said Scott Patten, MD, PhD, professor of psychiatry and epidemiology at the University of Calgary in Alberta, Canada. “But it’s important to emphasize that that’s not an officially recognized diagnosis by the major classifications.”

Researchers coined the term SAD 40 years ago to describe a pattern of depression that sets in during the fall or winter and remits in the spring or summer.

Clinicians are diagnosing the disorder, albeit without that exact moniker.

In the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the condition is considered a subtype of major depression.

So, for patients who meet criteria for recurrent major depressive disorder, the specifier “with seasonal pattern” might be applied.

The subtype covers cases where depressive episodes have followed a seasonal pattern for at least 2 years. Typically, onset occurs in the fall or winter followed by remission in the spring or summer. The opposite pattern is possible but less common.

When stressors such as seasonal unemployment better explain the pattern, the seasonal specifier should not be used, according to the manual. Bipolar disorder can follow a seasonal pattern as well.

Researchers estimate SAD affects about 5% of adults in the United States. The diagnosis is more common in women than in men, and more prevalent farther from the equator.

 

One Hallmark Symptom?

DSM-5 highlights characteristic features of winter depression, including:

  • Loss of energy
  • Hypersomnia
  • A craving for carbohydrates
  • Overeating
  • Weight gain

Kelly Rohan, PhD, a researcher at the University of Vermont, Burlington, who has studied SAD since the 1990s, sees one symptom as a possible hallmark for the disorder: fatigue.

“I’ve personally never met someone who met the full diagnostic criteria for the seasonal pattern that did not have fatigue as one of their symptoms,” Rohan said. “In theory, they could exist, but I have spoken to hundreds of people with seasonal depression, and I have never met them if, in fact, they do exist.”

That differs from nonseasonal depression, for which insomnia is a more common problem with sleep, Patten said.

Clinicians look for at least five symptoms of depression that cause substantial impairment and distress for at least 2 weeks, such as pervasive sadness, difficulty concentrating, low self-esteem, or loss of interest in hobbies.

An average episode of winter depression can last 5 months, however, Rohan said. “That’s a long time to be in a major depressive episode.”

 

Seeing Subsyndromal Cases

In people who do not meet criteria for major depression with a seasonal pattern, the change of seasons still can affect energy levels and mood. Some patients have “subsyndromal SAD” and may benefit from treatments that have been developed for SAD such as bright light therapy, said Paul Desan, MD, PhD, director of the Winter Depression Research Clinic at Yale School of Medicine in New Haven, Connecticut.

“Many people come to our clinic because they have seasonal changes that don’t meet the full criteria for depression, but nevertheless, they want help,” Desan said.

The 1984 paper that introduced the term SAD explored artificial bright light as a promising treatment for the condition. The researchers had heard from dozens of patients with “recurrent depressions that occur annually at the same time each year,” and bright light appeared to help alleviate their symptoms.

Subsequent trials have found the approach effective. Even in nonseasonal depression, bright light therapy may increase the likelihood of remission, a recent meta-analysis found. Light therapy also may bolster the effectiveness of antidepressant medication in nonseasonal major depressive disorder, a randomized trial has shown.

Other treatments for SAD include cognitive behavioral therapy (CBT) and bupropion XL, which is approved as a preventive medication. Other drugs for major depressive disorder may be used.

 

Quest for Biomarkers

To better understand SAD and how available treatments work, Rohan is conducting a study that examines potential biomarkers in patients treated with light therapy or CBT. She and her colleagues are examining circadian phase angle difference (how well internal clocks match daily routines) and post-illumination pupil response (how the pupil constricts after a light turns off). They also are measuring participants’ pupil responses and brain activity upon seeing words that are associated with winter or summer (like “blizzard,” “icy,” “sunshine,” and “picnics.”) 

Studies have shown treating patients to remission with CBT reduces the risk for recurrence in subsequent years, relative to other treatment approaches, Rohan said. That may be because CBT gives people tools to avoid slipping into another depressive episode.

 

Avoid Self-Diagnosis

Rohan cautions patients against self-diagnosis and treatment.

“Having a conversation with your doctor is a good starting point,” she said. “Just because you can walk into Costco and walk out with a light box doesn’t mean that you should.” 

Light therapy can have side effects, including headaches, eye strain, and making patients feel wired, and it can be a challenge to determine the right dose, Rohan said.

Desan’s clinic website provides information about available devices for light therapy for patients who are looking to try this approach, but Desan agrees clinicians — especially primary care clinicians — can play a crucial role in helping patients. In more serious cases, a mental health expert may be necessary.

To start light therapy, Desan’s clinic typically recommends patients try 30 minutes of 10,000 lux bright light — roughly the brightness of being outside on a sunny day — before 8 AM for a 4-week trial.

Still, other specific issues might explain why a patient is struggling during winter months, Patten said. For example, people might experience financial stress around the holidays or consume excessive amounts of alcohol during that time.

“It’s important for clinicians to think broadly about it,” Patten said. “It might not always be light therapy or a medication. It might be focusing on some other aspect of what is going on for them in the winter.” 

Rohan’s research is funded by the National Institute of Mental Health, and she receives royalties for a manual on treating SAD with CBT. Patten and Desan had no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

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Diabetes Drugs Promising for Alcohol Use Disorder

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Wed, 11/27/2024 - 02:49

TOPLINE:

Use of the glucagon-like peptide 1 (GLP-1) receptor agonists semaglutide and liraglutide is linked to a lower risk for alcohol use disorder (AUD)–related hospitalizations, compared with traditional AUD medications, a new study suggested.

METHODOLOGY:

  • Researchers conducted a nationwide cohort study from 2006 to 2023 in Sweden that included more than 220,000 individuals with AUD (mean age, 40 years; 64% men).
  • Data were obtained from registers of inpatient and specialized outpatient care, sickness absence, and disability pension, with a median follow-up period of 8.8 years.
  • The primary exposure measured was the use of individual GLP-1 receptor agonists — commonly used to treat type 2 diabetes and obesity — compared with nonuse.
  • The secondary exposure examined was the use of medications indicated for AUD.
  • The primary outcome was AUD-related hospitalization; secondary outcomes included hospitalization due to substance use disorder (SUD), somatic hospitalization, and suicide attempts.

TAKEAWAY:

  • About 59% of participants experienced AUD-related hospitalization.
  • Semaglutide users (n = 4321) had the lowest risk for hospitalization related to AUD (adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and to any SUD (aHR, 0.68; 95% CI, 0.54-0.85).
  • Liraglutide users (n = 2509) had the second lowest risk for both AUD-related (aHR, 0.72; 95% CI, 0.57-0.92) and SUD-related (aHR, 0.78; 95% CI, 0.64-0.97) hospitalizations.
  • The use of both semaglutide (aHR, 0.78; 95% CI, 0.68-0.90) and liraglutide (aHR, 0.79; 95% CI, 0.69-0.91) was linked to a reduced risk for hospitalization because of somatic reasons but was not associated with the risk of suicide attempts.
  • Traditional AUD medications showed modest effectiveness with a slightly decreased but nonsignificant risk for AUD-related hospitalization (aHR, 0.98).

IN PRACTICE:

“AUDs and SUDs are undertreated pharmacologically, despite the availability of effective treatments. However, novel treatments are also needed because existing treatments may not be suitable for all patients. Semaglutide and liraglutide may be effective in the treatment of AUD, and clinical trials are urgently needed to confirm these findings,” the investigators wrote.

SOURCE:

This study was led by Markku Lähteenvuo, MD, PhD, University of Eastern Finland, Niuvanniemi Hospital, Kuopio. It was published online on November 13 in JAMA Psychiatry.

LIMITATIONS:

The observational nature of this study limited causal inferences.

DISCLOSURES:

The data used in this study were obtained from the REWHARD consortium, supported by the Swedish Research Council. Four of the six authors reported receiving grants or personal fees from various sources outside the submitted work, which are fully listed in the original article.

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.

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TOPLINE:

Use of the glucagon-like peptide 1 (GLP-1) receptor agonists semaglutide and liraglutide is linked to a lower risk for alcohol use disorder (AUD)–related hospitalizations, compared with traditional AUD medications, a new study suggested.

METHODOLOGY:

  • Researchers conducted a nationwide cohort study from 2006 to 2023 in Sweden that included more than 220,000 individuals with AUD (mean age, 40 years; 64% men).
  • Data were obtained from registers of inpatient and specialized outpatient care, sickness absence, and disability pension, with a median follow-up period of 8.8 years.
  • The primary exposure measured was the use of individual GLP-1 receptor agonists — commonly used to treat type 2 diabetes and obesity — compared with nonuse.
  • The secondary exposure examined was the use of medications indicated for AUD.
  • The primary outcome was AUD-related hospitalization; secondary outcomes included hospitalization due to substance use disorder (SUD), somatic hospitalization, and suicide attempts.

TAKEAWAY:

  • About 59% of participants experienced AUD-related hospitalization.
  • Semaglutide users (n = 4321) had the lowest risk for hospitalization related to AUD (adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and to any SUD (aHR, 0.68; 95% CI, 0.54-0.85).
  • Liraglutide users (n = 2509) had the second lowest risk for both AUD-related (aHR, 0.72; 95% CI, 0.57-0.92) and SUD-related (aHR, 0.78; 95% CI, 0.64-0.97) hospitalizations.
  • The use of both semaglutide (aHR, 0.78; 95% CI, 0.68-0.90) and liraglutide (aHR, 0.79; 95% CI, 0.69-0.91) was linked to a reduced risk for hospitalization because of somatic reasons but was not associated with the risk of suicide attempts.
  • Traditional AUD medications showed modest effectiveness with a slightly decreased but nonsignificant risk for AUD-related hospitalization (aHR, 0.98).

IN PRACTICE:

“AUDs and SUDs are undertreated pharmacologically, despite the availability of effective treatments. However, novel treatments are also needed because existing treatments may not be suitable for all patients. Semaglutide and liraglutide may be effective in the treatment of AUD, and clinical trials are urgently needed to confirm these findings,” the investigators wrote.

SOURCE:

This study was led by Markku Lähteenvuo, MD, PhD, University of Eastern Finland, Niuvanniemi Hospital, Kuopio. It was published online on November 13 in JAMA Psychiatry.

LIMITATIONS:

The observational nature of this study limited causal inferences.

DISCLOSURES:

The data used in this study were obtained from the REWHARD consortium, supported by the Swedish Research Council. Four of the six authors reported receiving grants or personal fees from various sources outside the submitted work, which are fully listed in the original article.

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:

Use of the glucagon-like peptide 1 (GLP-1) receptor agonists semaglutide and liraglutide is linked to a lower risk for alcohol use disorder (AUD)–related hospitalizations, compared with traditional AUD medications, a new study suggested.

METHODOLOGY:

  • Researchers conducted a nationwide cohort study from 2006 to 2023 in Sweden that included more than 220,000 individuals with AUD (mean age, 40 years; 64% men).
  • Data were obtained from registers of inpatient and specialized outpatient care, sickness absence, and disability pension, with a median follow-up period of 8.8 years.
  • The primary exposure measured was the use of individual GLP-1 receptor agonists — commonly used to treat type 2 diabetes and obesity — compared with nonuse.
  • The secondary exposure examined was the use of medications indicated for AUD.
  • The primary outcome was AUD-related hospitalization; secondary outcomes included hospitalization due to substance use disorder (SUD), somatic hospitalization, and suicide attempts.

TAKEAWAY:

  • About 59% of participants experienced AUD-related hospitalization.
  • Semaglutide users (n = 4321) had the lowest risk for hospitalization related to AUD (adjusted hazard ratio [aHR], 0.64; 95% CI, 0.50-0.83) and to any SUD (aHR, 0.68; 95% CI, 0.54-0.85).
  • Liraglutide users (n = 2509) had the second lowest risk for both AUD-related (aHR, 0.72; 95% CI, 0.57-0.92) and SUD-related (aHR, 0.78; 95% CI, 0.64-0.97) hospitalizations.
  • The use of both semaglutide (aHR, 0.78; 95% CI, 0.68-0.90) and liraglutide (aHR, 0.79; 95% CI, 0.69-0.91) was linked to a reduced risk for hospitalization because of somatic reasons but was not associated with the risk of suicide attempts.
  • Traditional AUD medications showed modest effectiveness with a slightly decreased but nonsignificant risk for AUD-related hospitalization (aHR, 0.98).

IN PRACTICE:

“AUDs and SUDs are undertreated pharmacologically, despite the availability of effective treatments. However, novel treatments are also needed because existing treatments may not be suitable for all patients. Semaglutide and liraglutide may be effective in the treatment of AUD, and clinical trials are urgently needed to confirm these findings,” the investigators wrote.

SOURCE:

This study was led by Markku Lähteenvuo, MD, PhD, University of Eastern Finland, Niuvanniemi Hospital, Kuopio. It was published online on November 13 in JAMA Psychiatry.

LIMITATIONS:

The observational nature of this study limited causal inferences.

DISCLOSURES:

The data used in this study were obtained from the REWHARD consortium, supported by the Swedish Research Council. Four of the six authors reported receiving grants or personal fees from various sources outside the submitted work, which are fully listed in the original article.

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.

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Kidney, Cardiovascular Benefits Seen With GLP-1 RA Drugs in SLE, Lupus Nephritis

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Wed, 11/27/2024 - 02:49

— Glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications appear beneficial for people with systemic lupus erythematosus (SLE) and lupus nephritis, two new studies suggest. 

“The risk of cardiovascular disease is thought to be at least double that for people with lupus ... and we know the risk of progressing to end-stage renal disease [ESKD] for patients with lupus nephritis can be as high as 10%-30%, so there’s clearly a major unmet need for new treatments and approaches to improve these outcomes, perhaps with adjunctive treatment beyond our typical immunosuppressive therapy,” April Jorge, MD, of Massachusetts General Hospital, Boston, said at the annual meeting of the American College of Rheumatology (ACR)

The GLP-1 RAs are approved for the treatment of type 2 diabetes (T2D) and obesity. They also have proven cardiovascular benefit, along with emerging data suggesting kidney protection independent of glucose lowering. Jorge presented findings from a study using data from the US multicenter electronic health record database TriNetX, showing that, among patients who had both T2D and SLE, those using GLP-1 RAs had lower risks for major adverse cardiac events (MACE), venous thrombosis, kidney disease progression, and all-cause mortality, compared with those using a different class of T2D medication. 

A second study using TriNetX, presented at the same ACR meeting session by Anna-Kay Palmer, MD, a third-year internal medicine resident at Jefferson Einstein Hospital, Philadelphia, Pennsylvania, showed that GLP-1 RAs reduced the risk of progression to ESKD in patients with lupus nephritis, possibly caused by reductions in pro-inflammatory mediators.

Asked to comment, session moderator Diane L. Kamen, MD, professor of medicine at the Medical University of South Carolina Division of Rheumatology, Charleston, said in an interview that she definitely supports the use of GLP-1 RAs for patients who have SLE and/or lupus nephritis and also a drug label indication, either T2D or obesity. “[The GLP-1 RA prescriber] will usually run it by rheumatology to make sure that it doesn’t conflict with any of their other medical treatment, and it’s very reassuring to know that they could actually get a win-win.” 

But as far as prescribing off-label for those with SLE/lupus nephritis who don’t have other GLP-1 RA indications, Kamen said, “that’s a black hole at this point. We need to do those prospective studies. But if they have another indication, yes.”

 

Cardiovascular, Kidney Benefits of GLP-1 RAs

Jorge noted that patients with lupus were excluded from the randomized clinical trials of GLP-1 RAs, so the current study was designed to investigate the potential impact of these medications on cardiovascular and kidney outcomes in patients with SLE and lupus nephritis. 

From TriNetX data for 46 healthcare organizations nationwide, a total of 96,511 patients with both SLE and T2D but not ESKD had initiated either a GLP-1 RA or another diabetes drug class, dipeptidyl peptidase 4 inhibitors (DPP4i), between October 2006 and August 2021. Of those, 29,177 had lupus nephritis. 

Propensity score matching for factors such as demographics, lupus severity, comorbidities, and medication use was used to emulate a randomized trial. This yielded 25,838 with SLE and T2D, of whom 910 initiated a GLP-1 RA and 1004 started a DPP4i, and 12,387 with lupus nephritis and T2D, including 267 on a GLP-1 RA and 324 on a DPP4i. After matching, the mean age was 55 years, more than 90% were women, and just under half were White individuals. About one third had chronic kidney disease stages ≥ 3, and about 15% had heart failure. 

Over an average follow-up time of 1.2-1.4 years among those with SLE, the hazard ratio (HR) for MACE (a composite of myocardial infarction, stroke, and heart failure) for those taking a GLP-1 RA vs a DPP4i was 0.66, a significant difference. And for venous thrombosis, the HR was also significant at 0.49.

Kidney disease progression, defined as an estimated glomerular filtration rate decline of 30% or more or new ESKD, was significantly less likely in the GLP-1 RA group, with a HR of 0.77. All-cause mortality also was dramatically reduced (HR, 0.26). As expected, there was no difference in control outcome, genital infections (HR, 1.02). 

In the subgroup with lupus nephritis, there were also lower risks for both MACE (HR, 0.64) and for renal progression (HR, 0.70). “The findings suggest similar cardiac and kidney benefits among patients with SLE and lupus nephritis as have been observed in other populations,” Jorge concluded. 

Kamen commented that the study design “was pretty brilliant, because you wouldn’t be able to do a placebo-controlled trial since the indication was diabetes ... but the fact is you do see that the GLP-1 RA gets the benefit whereas the other drug does not.”

Next steps, Jorge said, will be mechanistic studies to better understand the effects of GLP-1 RAs in lupus and other rheumatic diseases, prospective studies of GLP-1 RAs in SLE and lupus nephritis without diabetes, and clarification of ideal timing for GLP-1 RA use in SLE and lupus nephritis. 

“Ideally, with our prospective studies with these patients we can try to isolate the effect on patients with lupus and also better understand whether there might be an impact on disease activity through the anti-inflammatory effects of these medications, rather than just the cardioprotective and nephroprotective benefits,” she said. 

 

In Those With Lupus Nephritis, Kidney Protection Seen

In her presentation, Palmer noted that, despite immunosuppressive therapies for SLE, 10%-20% of patients who develop lupus nephritis will progress to ESKD within 5 years of diagnosis. 

She added that GLP-1 RAs have been shown to reduce albuminuria in people with diabetes and have been hypothesized to reduce inflammation through multiple pathways, thereby potentially reducing kidney disease independently of the presence of diabetes or weight loss. These pathways include modulating immune cell signaling and reducing pro-inflammatory cytokines. 

Based on all this, Palmer and colleagues used International Classification of Diseases – 10th edition diagnostic codes in TriNetX to identify 839 patients who had been diagnosed with lupus nephritis between 2014 and 2024 and who were prescribed liraglutide, dulaglutide, semaglutide, or exenatide for any time after the lupus nephritis diagnosis. Another 29,840 patients with lupus nephritis had not used GLP-1 RAs. 

After 1:1 propensity score matching for age, sex, race, ethnicity, presence of hypertension, diabetes, use of immunosuppressive and diabetes medication, smoking, obesity, and statin use, there were 735 individuals in each group. About two thirds in each had diabetes, whereas the rest had been prescribed the GLP-1 RAs for other indications. 

Patients who were not on GLP-1 RAs were twice as likely to develop ESKD or dialysis (8.88% vs 3.971%; odds ratio, 2.35; P = .001). 

Kamen pointed out that not including the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers was a study flaw. On the other hand, the fact that not everyone in this study had diabetes was an advantage.

Jorge received grant/research support from Bristol-Myers Squibb, Cabaletta Bio, and the Lupus Clinical Investigator Network. Kamen is an adviser/review panel member for Alpine Immune Sciences. Palmer had no disclosures.

A version of this article appeared on Medscape.com.

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— Glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications appear beneficial for people with systemic lupus erythematosus (SLE) and lupus nephritis, two new studies suggest. 

“The risk of cardiovascular disease is thought to be at least double that for people with lupus ... and we know the risk of progressing to end-stage renal disease [ESKD] for patients with lupus nephritis can be as high as 10%-30%, so there’s clearly a major unmet need for new treatments and approaches to improve these outcomes, perhaps with adjunctive treatment beyond our typical immunosuppressive therapy,” April Jorge, MD, of Massachusetts General Hospital, Boston, said at the annual meeting of the American College of Rheumatology (ACR)

The GLP-1 RAs are approved for the treatment of type 2 diabetes (T2D) and obesity. They also have proven cardiovascular benefit, along with emerging data suggesting kidney protection independent of glucose lowering. Jorge presented findings from a study using data from the US multicenter electronic health record database TriNetX, showing that, among patients who had both T2D and SLE, those using GLP-1 RAs had lower risks for major adverse cardiac events (MACE), venous thrombosis, kidney disease progression, and all-cause mortality, compared with those using a different class of T2D medication. 

A second study using TriNetX, presented at the same ACR meeting session by Anna-Kay Palmer, MD, a third-year internal medicine resident at Jefferson Einstein Hospital, Philadelphia, Pennsylvania, showed that GLP-1 RAs reduced the risk of progression to ESKD in patients with lupus nephritis, possibly caused by reductions in pro-inflammatory mediators.

Asked to comment, session moderator Diane L. Kamen, MD, professor of medicine at the Medical University of South Carolina Division of Rheumatology, Charleston, said in an interview that she definitely supports the use of GLP-1 RAs for patients who have SLE and/or lupus nephritis and also a drug label indication, either T2D or obesity. “[The GLP-1 RA prescriber] will usually run it by rheumatology to make sure that it doesn’t conflict with any of their other medical treatment, and it’s very reassuring to know that they could actually get a win-win.” 

But as far as prescribing off-label for those with SLE/lupus nephritis who don’t have other GLP-1 RA indications, Kamen said, “that’s a black hole at this point. We need to do those prospective studies. But if they have another indication, yes.”

 

Cardiovascular, Kidney Benefits of GLP-1 RAs

Jorge noted that patients with lupus were excluded from the randomized clinical trials of GLP-1 RAs, so the current study was designed to investigate the potential impact of these medications on cardiovascular and kidney outcomes in patients with SLE and lupus nephritis. 

From TriNetX data for 46 healthcare organizations nationwide, a total of 96,511 patients with both SLE and T2D but not ESKD had initiated either a GLP-1 RA or another diabetes drug class, dipeptidyl peptidase 4 inhibitors (DPP4i), between October 2006 and August 2021. Of those, 29,177 had lupus nephritis. 

Propensity score matching for factors such as demographics, lupus severity, comorbidities, and medication use was used to emulate a randomized trial. This yielded 25,838 with SLE and T2D, of whom 910 initiated a GLP-1 RA and 1004 started a DPP4i, and 12,387 with lupus nephritis and T2D, including 267 on a GLP-1 RA and 324 on a DPP4i. After matching, the mean age was 55 years, more than 90% were women, and just under half were White individuals. About one third had chronic kidney disease stages ≥ 3, and about 15% had heart failure. 

Over an average follow-up time of 1.2-1.4 years among those with SLE, the hazard ratio (HR) for MACE (a composite of myocardial infarction, stroke, and heart failure) for those taking a GLP-1 RA vs a DPP4i was 0.66, a significant difference. And for venous thrombosis, the HR was also significant at 0.49.

Kidney disease progression, defined as an estimated glomerular filtration rate decline of 30% or more or new ESKD, was significantly less likely in the GLP-1 RA group, with a HR of 0.77. All-cause mortality also was dramatically reduced (HR, 0.26). As expected, there was no difference in control outcome, genital infections (HR, 1.02). 

In the subgroup with lupus nephritis, there were also lower risks for both MACE (HR, 0.64) and for renal progression (HR, 0.70). “The findings suggest similar cardiac and kidney benefits among patients with SLE and lupus nephritis as have been observed in other populations,” Jorge concluded. 

Kamen commented that the study design “was pretty brilliant, because you wouldn’t be able to do a placebo-controlled trial since the indication was diabetes ... but the fact is you do see that the GLP-1 RA gets the benefit whereas the other drug does not.”

Next steps, Jorge said, will be mechanistic studies to better understand the effects of GLP-1 RAs in lupus and other rheumatic diseases, prospective studies of GLP-1 RAs in SLE and lupus nephritis without diabetes, and clarification of ideal timing for GLP-1 RA use in SLE and lupus nephritis. 

“Ideally, with our prospective studies with these patients we can try to isolate the effect on patients with lupus and also better understand whether there might be an impact on disease activity through the anti-inflammatory effects of these medications, rather than just the cardioprotective and nephroprotective benefits,” she said. 

 

In Those With Lupus Nephritis, Kidney Protection Seen

In her presentation, Palmer noted that, despite immunosuppressive therapies for SLE, 10%-20% of patients who develop lupus nephritis will progress to ESKD within 5 years of diagnosis. 

She added that GLP-1 RAs have been shown to reduce albuminuria in people with diabetes and have been hypothesized to reduce inflammation through multiple pathways, thereby potentially reducing kidney disease independently of the presence of diabetes or weight loss. These pathways include modulating immune cell signaling and reducing pro-inflammatory cytokines. 

Based on all this, Palmer and colleagues used International Classification of Diseases – 10th edition diagnostic codes in TriNetX to identify 839 patients who had been diagnosed with lupus nephritis between 2014 and 2024 and who were prescribed liraglutide, dulaglutide, semaglutide, or exenatide for any time after the lupus nephritis diagnosis. Another 29,840 patients with lupus nephritis had not used GLP-1 RAs. 

After 1:1 propensity score matching for age, sex, race, ethnicity, presence of hypertension, diabetes, use of immunosuppressive and diabetes medication, smoking, obesity, and statin use, there were 735 individuals in each group. About two thirds in each had diabetes, whereas the rest had been prescribed the GLP-1 RAs for other indications. 

Patients who were not on GLP-1 RAs were twice as likely to develop ESKD or dialysis (8.88% vs 3.971%; odds ratio, 2.35; P = .001). 

Kamen pointed out that not including the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers was a study flaw. On the other hand, the fact that not everyone in this study had diabetes was an advantage.

Jorge received grant/research support from Bristol-Myers Squibb, Cabaletta Bio, and the Lupus Clinical Investigator Network. Kamen is an adviser/review panel member for Alpine Immune Sciences. Palmer had no disclosures.

A version of this article appeared on Medscape.com.

— Glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications appear beneficial for people with systemic lupus erythematosus (SLE) and lupus nephritis, two new studies suggest. 

“The risk of cardiovascular disease is thought to be at least double that for people with lupus ... and we know the risk of progressing to end-stage renal disease [ESKD] for patients with lupus nephritis can be as high as 10%-30%, so there’s clearly a major unmet need for new treatments and approaches to improve these outcomes, perhaps with adjunctive treatment beyond our typical immunosuppressive therapy,” April Jorge, MD, of Massachusetts General Hospital, Boston, said at the annual meeting of the American College of Rheumatology (ACR)

The GLP-1 RAs are approved for the treatment of type 2 diabetes (T2D) and obesity. They also have proven cardiovascular benefit, along with emerging data suggesting kidney protection independent of glucose lowering. Jorge presented findings from a study using data from the US multicenter electronic health record database TriNetX, showing that, among patients who had both T2D and SLE, those using GLP-1 RAs had lower risks for major adverse cardiac events (MACE), venous thrombosis, kidney disease progression, and all-cause mortality, compared with those using a different class of T2D medication. 

A second study using TriNetX, presented at the same ACR meeting session by Anna-Kay Palmer, MD, a third-year internal medicine resident at Jefferson Einstein Hospital, Philadelphia, Pennsylvania, showed that GLP-1 RAs reduced the risk of progression to ESKD in patients with lupus nephritis, possibly caused by reductions in pro-inflammatory mediators.

Asked to comment, session moderator Diane L. Kamen, MD, professor of medicine at the Medical University of South Carolina Division of Rheumatology, Charleston, said in an interview that she definitely supports the use of GLP-1 RAs for patients who have SLE and/or lupus nephritis and also a drug label indication, either T2D or obesity. “[The GLP-1 RA prescriber] will usually run it by rheumatology to make sure that it doesn’t conflict with any of their other medical treatment, and it’s very reassuring to know that they could actually get a win-win.” 

But as far as prescribing off-label for those with SLE/lupus nephritis who don’t have other GLP-1 RA indications, Kamen said, “that’s a black hole at this point. We need to do those prospective studies. But if they have another indication, yes.”

 

Cardiovascular, Kidney Benefits of GLP-1 RAs

Jorge noted that patients with lupus were excluded from the randomized clinical trials of GLP-1 RAs, so the current study was designed to investigate the potential impact of these medications on cardiovascular and kidney outcomes in patients with SLE and lupus nephritis. 

From TriNetX data for 46 healthcare organizations nationwide, a total of 96,511 patients with both SLE and T2D but not ESKD had initiated either a GLP-1 RA or another diabetes drug class, dipeptidyl peptidase 4 inhibitors (DPP4i), between October 2006 and August 2021. Of those, 29,177 had lupus nephritis. 

Propensity score matching for factors such as demographics, lupus severity, comorbidities, and medication use was used to emulate a randomized trial. This yielded 25,838 with SLE and T2D, of whom 910 initiated a GLP-1 RA and 1004 started a DPP4i, and 12,387 with lupus nephritis and T2D, including 267 on a GLP-1 RA and 324 on a DPP4i. After matching, the mean age was 55 years, more than 90% were women, and just under half were White individuals. About one third had chronic kidney disease stages ≥ 3, and about 15% had heart failure. 

Over an average follow-up time of 1.2-1.4 years among those with SLE, the hazard ratio (HR) for MACE (a composite of myocardial infarction, stroke, and heart failure) for those taking a GLP-1 RA vs a DPP4i was 0.66, a significant difference. And for venous thrombosis, the HR was also significant at 0.49.

Kidney disease progression, defined as an estimated glomerular filtration rate decline of 30% or more or new ESKD, was significantly less likely in the GLP-1 RA group, with a HR of 0.77. All-cause mortality also was dramatically reduced (HR, 0.26). As expected, there was no difference in control outcome, genital infections (HR, 1.02). 

In the subgroup with lupus nephritis, there were also lower risks for both MACE (HR, 0.64) and for renal progression (HR, 0.70). “The findings suggest similar cardiac and kidney benefits among patients with SLE and lupus nephritis as have been observed in other populations,” Jorge concluded. 

Kamen commented that the study design “was pretty brilliant, because you wouldn’t be able to do a placebo-controlled trial since the indication was diabetes ... but the fact is you do see that the GLP-1 RA gets the benefit whereas the other drug does not.”

Next steps, Jorge said, will be mechanistic studies to better understand the effects of GLP-1 RAs in lupus and other rheumatic diseases, prospective studies of GLP-1 RAs in SLE and lupus nephritis without diabetes, and clarification of ideal timing for GLP-1 RA use in SLE and lupus nephritis. 

“Ideally, with our prospective studies with these patients we can try to isolate the effect on patients with lupus and also better understand whether there might be an impact on disease activity through the anti-inflammatory effects of these medications, rather than just the cardioprotective and nephroprotective benefits,” she said. 

 

In Those With Lupus Nephritis, Kidney Protection Seen

In her presentation, Palmer noted that, despite immunosuppressive therapies for SLE, 10%-20% of patients who develop lupus nephritis will progress to ESKD within 5 years of diagnosis. 

She added that GLP-1 RAs have been shown to reduce albuminuria in people with diabetes and have been hypothesized to reduce inflammation through multiple pathways, thereby potentially reducing kidney disease independently of the presence of diabetes or weight loss. These pathways include modulating immune cell signaling and reducing pro-inflammatory cytokines. 

Based on all this, Palmer and colleagues used International Classification of Diseases – 10th edition diagnostic codes in TriNetX to identify 839 patients who had been diagnosed with lupus nephritis between 2014 and 2024 and who were prescribed liraglutide, dulaglutide, semaglutide, or exenatide for any time after the lupus nephritis diagnosis. Another 29,840 patients with lupus nephritis had not used GLP-1 RAs. 

After 1:1 propensity score matching for age, sex, race, ethnicity, presence of hypertension, diabetes, use of immunosuppressive and diabetes medication, smoking, obesity, and statin use, there were 735 individuals in each group. About two thirds in each had diabetes, whereas the rest had been prescribed the GLP-1 RAs for other indications. 

Patients who were not on GLP-1 RAs were twice as likely to develop ESKD or dialysis (8.88% vs 3.971%; odds ratio, 2.35; P = .001). 

Kamen pointed out that not including the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers was a study flaw. On the other hand, the fact that not everyone in this study had diabetes was an advantage.

Jorge received grant/research support from Bristol-Myers Squibb, Cabaletta Bio, and the Lupus Clinical Investigator Network. Kamen is an adviser/review panel member for Alpine Immune Sciences. Palmer had no disclosures.

A version of this article appeared on Medscape.com.

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Trump Nominations for US Health Agencies Spark Controversy, Criticism, Praise

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President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

A version of this article first appeared on Medscape.com.

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President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

A version of this article first appeared on Medscape.com.

President-elect Donald Trump’s vision for the nation’s top health agencies is coming into focus with three nominations announced Nov. 22 that drew both criticism and praise:

  • Surgeon and health researcher Martin A. Makary, MD, MPH, to lead the US Food and Drug Administration (FDA).
  • Former Republican congressman and physician David J. Weldon, MD, for director of the US Centers for Disease Control and Prevention (CDC).
  • Fox News contributor Janette Nesheiwat, MD, for surgeon general.

Earlier in November, Trump nominated vaccine skeptic and former presidential candidate Robert F. Kennedy Jr. to lead the US Department of Health and Human Services (HHS). 

Here’s what to know about the latest nominees, who, like Kennedy, must be confirmed by the US Senate.

 

Martin A. Makary

Currently a professor at the Johns Hopkins School of Medicine and chief of islet transplant surgery at Johns Hopkins Hospital, Makary co-invented in 2006 a surgery checklist that became a widely-used patient safety tool. 

As a US FDA commissioner, Makary would preside over a $6.5 billion agency with more than 18,000 employees. The agency, part of HHS, oversees human and animal drugs and vaccines, medical devices, food, tobacco and other products. Some of Makary’s views align closely with those of HHS nominee Kennedy. 

Makary is also chief medical officer of telehealth platform Sesame.

Makary was primarily known as a health researcher and author of books about price transparency and the cost of health care until the COVID-19 pandemic, when he became an outspoken critic of the federal response, lambasting restrictions and mandates advocated by the CDC and other public health officials. 

In 2023, Makary told the House Select Subcommittee on the COVID Pandemic that federal officials had ignored what he called “natural immunity.” Studies have shown that natural immunity is “at least as effective as vaccinated immunity, and probably better,” testified Makary.

Makary called for an overhaul of the US FDA in a 2021 Fox News opinion, saying that its culture was “defined by counterproductive rigidity and a refusal to adapt.”

Blind Spots, his most recent book, takes on what he calls “medical dogma” and challenges conventional views on subjects ranging from the microbiome to marijuana to cancer prevention, hormone replacement therapy, antibiotics and peanut allergies.

In an interview he posted to X, Makary blames inappropriate use of antibiotics for a variety of childhood illnesses. He cites increases in obesity, learning disabilities, attention deficit disorder, asthma, celiac disease, ulcerative colitis and Crohn’s disease as all potentially causally related to antibiotics given in childhood.

Makary is an advisor to two conservative think tanks, the Foundation for Research on Equal Opportunity, and to Paragon Health Institute, begun in 2021 by two former top officials in the previous Trump administration.

Makary would “cut the bureaucratic red tape at the agency to make sure Americans get the medical cures and treatments they deserve,” Trump said on his social media platform, Truth Social, and in a press release.

While Los Angeles Times owner and physician-entrepreneur Patrick Soon-Shiong, MBBCh, MSc, praised the nomination of Makary (and the two other nominees) as “inspired,” other physicians criticized Makary for his anti-COVID mandate views and “fear-mongering” over COVID vaccine side effects.

 

Janette Nesheiwat

As surgeon general, Nesheiwat would serve as the top “health communicator in chief” and oversee the 6000 member US Public Health Service Commissioned Corps.

She is a frequent medical contributor to Fox News and serves as a medical director for a group of urgent care clinics in New York. She received her medical degree from the American University of the Caribbean School of Medicine and completed a family medicine residency at the University of Arkansas for Medical Sciences. She is board-certified in family medicine.

Nesheiwat sells vitamin supplements on her website and in December will publish a book on “miracles in medicine” and her Christian faith. 

Trump said in a statement that Nesheiwat “is a fierce advocate and strong communicator for preventive medicine and public health. She is committed to ensuring that Americans have access to affordable, quality healthcare, and believes in empowering individuals to take charge of their health to live longer, healthier lives.”

While Nesheiwat was critical of COVID mandates, she voiced more support for COVID vaccines and mask-wearing during the pandemic than her fellow nominees, leading some Trump supporters to criticize her nomination. 

“A good appointment, happy about this: I got to know @DoctorJanette during the pandemic, exchanging information. She is very smart, thoughtful, interested in learning, and a compassionate doctor, and…a truly nice person,” noted vaccine researcher Peter Hotez, MD, PhD, said on X.

 

David J. Weldon

If confirmed, former congressman Weldon would oversee the sprawling CDC, an agency with a roughly $17 billion budget, 15,000 employees or contractors, and numerous centers covering everything from health statistics to vaccines to epidemiology.

After earning his medical degree from the University at Buffalo School of Medicine, Weldon served in the US Army and US Army reserve. The Republican later served for 14 years in Congress representing Florida’s 15th district, which covers the Tampa region.

He now practices as an internist in Brevard County, Florida.

In Congress, Weldon raised concerns about the safety of some vaccines and promoted the false narrative that a former vaccine ingredient, thimerosal, caused autism, the Washington Post reported. Thimerosal has not been used in child vaccines for more than two decades. He also introduced a bill to move vaccine safety oversight from the CDC to an independent agency within HHS.

Trump said in a statement that Weldon “will proudly restore the CDC to its true purpose, and will work to end the Chronic Disease Epidemic.” 

But some physicians criticized Weldon for what they called his anti-vaccine views.

A version of this article first appeared on Medscape.com.

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Low-Dose Oral Minoxidil: Expert Consensus Provide Guidance for Treating Hair Loss

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Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Dr. Benjamin N. Ungar



Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Dr. Jennifer Fu



 

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.



 

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Dr. Adam Friedman



Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

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Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Dr. Benjamin N. Ungar



Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Dr. Jennifer Fu



 

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.



 

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Dr. Adam Friedman



Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

Recently published consensus guidelines for low-dose oral minoxidil (LDOM) treatment of hair loss provide best-practice recommendations in areas ranging from pretreatment considerations and counseling to patient monitoring. With large randomized, controlled trials lacking, the guidelines authors and other dermatologists said the paper provides practical pointers that should increase clinicians’ confidence in prescribing LDOM for hair loss.

Comfort and Confidence

Benjamin N. Ungar, MD, director of the Alopecia Center of Excellence at Mount Sinai Icahn School of Medicine, New York City, said he hopes that the guidelines will “make dermatologists in practice more comfortable with the use of low-dose oral minoxidil to treat different kinds of hair loss, and therefore, more patients will benefit.” He was not an author of the paper, which was published online in JAMA Dermatology on November 20, but was asked to comment.

Dr. Benjamin N. Ungar



Members of the multidisciplinary Low-Dose Oral Minoxidil Initiation steering committee recruited dermatologists with hair loss expertise from 12 countries. Using a modified four-round Delphi process that required at least 70% agreement, the group of 43 dermatologists crafted 76 consensus statements. “Notably,” said Co-senior author Jennifer Fu, MD, director of the Hair Disorders Clinic at the University of California, San Francisco, “27 items achieved at least 90% consensus after the first two rounds, indicating broad agreement in expert practice.”

Dr. Jennifer Fu



 

Indications for LDOM

At least 90% of experts concurred regarding the appropriateness of LDOM use for androgenetic alopecia (AGA) and age-related thinning and in cases where topical minoxidil proves ineffective or problematic. Additional situations in which LDOM might provide direct benefit involve follicular miniaturization, such as alopecia areata, or hair cycle disruption, such as chemotherapy. The authors also recommended considering LDOM over topical minoxidil when the latter is more expensive and when patients desire enhanced hypertrichosis.

 

Contraindications and Precautions

Before prescribing LDOM, the authors wrote, clinicians may consult with primary care or cardiology when contraindications (cardiovascular issues, pregnancy/nursing, and potential drug interactions) or precautions (history of tachycardia or arrhythmia, hypotension, or impaired kidney function) exist. Patients with precautions may require blood pressure monitoring, as well as monitoring for adverse effects of treatment. The panel also suggested the latter for all patients at the time of LDOM initiation and dose escalation. The authors advised against routine baseline laboratory and EKG testing in cases without relevant precautions.



 

Dosing Considerations

Along with systemic adverse event risk and baseline hair loss severity, key dosing considerations include patient age, sex, and whether patients desire hypertrichosis. Consensus on daily doses for adolescent females and males begins at 0.625 mg and 1.25 mg, respectively, and ranges up to 2.5 mg for adolescent females vs 5 mg for adult females and adolescent and adult males.

Presently, said Ungar, many dermatologists — including some who prescribe LDOM — remain uncomfortable even with very low doses, perhaps because of an invalid perception of cardiovascular safety issues including potential hypotension and pericardial effusions. However, recently published data include a review published November 7 in the Journal of the American Academy of Dermatology, which showed no significant effect of LDOM on blood pressure. And in a September Journal of Drugs in Dermatology article the authors found no impact on pericardial effusions in a 100-patient cohort.

Some dermatologists worry about the impact hypertrichosis may have on patients, Ungar added. Although incidence estimates range from 15% to 30%, he said, more than half of his patients experience hypertrichosis. “However, most continue treatment because the beneficial effects outweigh the effect of hypertrichosis.”



 

Practical Roadmap

Adam Friedman, MD, who was not involved with the publication, applauds its inclusion of pragmatic clinical guidance, which he said consensus papers often lack. “This paper sets a great roadmap for working low-dose oral minoxidil into your clinical practice, Friedman, professor and chair of dermatology at George Washington University, Washington, DC, said in an interview.

Dr. Adam Friedman



Rather than limiting LDOM use to AGA, he said, the paper is most helpful in showing the spectrum of disease states for which the expert panel prescribes LDOM. “We use it as adjunctive therapy for many other things, both scarring and nonscarring hair loss,” he added.

In appropriate clinical contexts, the authors wrote, clinicians may consider combining LDOM with spironolactone or beta-blockers. Friedman said that in his hands, combining LDOM with a 5-alpha reductase inhibitor (5ARI) is “absolutely outstanding.” Minoxidil increases blood flow to the scalp, he explained, while 5ARIs prevent production of dihydrotestosterone, which miniaturizes hair.

Fu said, “We hope these consensus outcomes will be helpful to dermatology colleagues as they consider using LDOM to treat hair loss in their adult and adolescent patient populations. We anticipate that these guidelines will be updated as additional evidence-based data emerges and are encouraged that we are already seeing new publications on this topic.”

Important areas for future research, she noted, include pediatric use of LDOM, the comparative efficacy of topical vs oral minoxidil, the safety of oral minoxidil for patients with a history of allergic contact dermatitis to topical minoxidil, and the use of other off-label forms of minoxidil, such as compounded oral minoxidil and sublingual minoxidil.

The study was funded by the University of California, San Francisco, Department of Dermatology Medical Student Summer Research Fellowship Program. Fu reported personal fees from Pfizer, Eli Lilly and Company, and Sun Pharma outside of the study. The full list of author disclosures can be found in the paper. Ungar and Friedman reported no relevant financial relationships.

 

A version of this article appeared on Medscape.com.

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AGA Guidelines Endorse Earlier Use of High-Efficacy Drugs for Ulcerative Colitis

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In a rapidly expanding therapeutic landscape, the American Gastroenterological Association (AGA) has issued updated practice guidelines for the pharmacological management of moderate to severe ulcerative colitis (UC) in adult outpatients.

“These are the first living guidelines published by a GI society, highlighting the interest and need to provide timely guidance to all stakeholders in a rapidly evolving field,” first author Siddharth Singh, MD, of the Division of Gastroenterology in the Department of Medicine at University of California, San Diego, said in an interview. Living guidance allows for ongoing revision of individual recommendations as new data emerge. Nearly 2 million Americans have UC.

 

Dr. Manasi Agrawal

Issued in Gastroenterology and updating the last guidance in 2020, the recommendations suggest more efficacious drugs should be used sooner. “Early use of advanced therapies including biologics and small-molecule drugs are more effective than 5-aminosalicylates [5-ASAs] or thiopurines and methotrexate for most patients with moderate to severe UC and those with poor prognostic factors,” coauthor and gastroenterologist Manasi Agrawal, MD, MS, an assistant professor of medicine at Icahn School of Medicine at Mount Sinai in New York City, said in an interview.

“We provide a practical guidance based on best-available evidence to make it easy for the treating clinician to make informed choices from the multiplicity of available treatments for UC,” added guidelines coauthor Ashwin Ananthakrishnan, MBBS, MPH, AGAF, a gastroenterologist at Massachusetts General Hospital in Boston.

 

Dr. Ashwin N. Ananthakrishnan

The comprehensive, patient-centered document comes with this caveat from the AGA panel: “These guidelines are meant to be broad recommendations for management of patients with moderate to severe UC and are not intended to address the intricacies of individual patients,” they wrote. “Provider experience and patient values and preferences can inform treating providers and patients to reasonably choose alternative treatment options.”

One gastroenterologist who has been eagerly awaiting these guidelines but not involved in the panel is James D. Lewis, MD, MSCE, AGAF, a professor of medicine and epidemiology at Perelman School of Medicine at the University of Pennsylvania, Philadelphia. “The choice of medications for moderately to severely active UC has expanded tremendously in the past few years,” he said in an interview. “This resulted in the dismantling of the historical therapeutic pyramid.” And while there are many more treatment options, knowing which medication to use for which patient and in which sequence has become much more complicated. 

“These guidelines will be extremely helpful for clinicians trying to navigate this new era of UC care,” he said.

The guidelines also outline implementation considerations for optimal use in different scenarios. “Key considerations include patient-related factors such as age, frailty, other health conditions, consideration for pregnancy, patient preferences, and access to healthcare,” Agrawal said.

 

Specifics

Overall, the guidance recommends advanced or immunomodulatory therapy after failure of 5-ASAs rather than a step-up approach. Moderate to severe disease is defined as a Mayo endoscopic severity subscore of 2 or 3.

The recommendation may also apply to mild disease in the presence of a high burden of inflammation and a poor prognosis or steroid dependence or resistance.

The AGA guideline panelists took account of differences in treatment efficacy between drugs within the same therapeutic class and made their recommendations by specific drugs rather than therapy class.

Based on varying degrees of evidence certainty, the AGA recommends or suggests the following management specifics in adult outpatients with moderate to severe disease:

  • Any of the following is recommended over no treatment: infliximab (Remicade), golimumab (Simponi), vedolizumab (Entyvio), tofacitinib (Xeljanz), upadacitinib (Rinvoq), ustekinumab (Stelara), ozanimod (Zeposia), etrasimod (Velsipity), risankizumab (Skyrizi), and guselkumab (Tremfya).
  • Adalimumab (Humira), filgotinib (Jyseleca), and mirikizumab (Omvoh) are suggested over no treatment.
  • Biosimilars to infliximabadalimumab, and ustekinumab can be considered of equivalent efficacy to their originator drugs.
  • For patients naive to advanced therapies, the AGA panel proposes using a higher-efficacy medication (eg, infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, and guselkumab) or an intermediate-efficacy medication (golimumab, ustekinumab, tofacitinib, filgotinib, and mirikizumab) rather than a lower-efficacy medication such as adalimumab.
  • In patients previously exposed to advanced therapy, particularly tumor necrosis factor (TNF)–alpha antagonists, the panel suggests using a higher-efficacy medication (tofacitinib, upadacitinib, and ustekinumab) or an intermediate-efficacy agent (filgotinib, mirikizumab, risankizumab, and guselkumab) over a lower-efficacy medication (adalimumab, vedolizumab, ozanimod, and etrasimod).
  • The panel suggests against the use of thiopurine monotherapy for inducing remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
  • The panel suggests against the use of methotrexate monotherapy for induction or maintenance of remission.
  • Infliximab, adalimumab, and golimumab in combination with an immunomodulator are suggested over monotherapy.
  • The panel makes no recommendation for or against non-TNF antagonist biologics in combination with an immunomodulator over non-TNF biologics alone.
  • For patients in corticosteroid-free clinical remission for at least 6 months on combination therapy with TNF antagonists and immunomodulators, the panel suggests against withdrawing TNF antagonists but makes no recommendation for or against withdrawing immunomodulators.
  • For those who have failed 5-ASAs and have escalated to immunomodulators or advanced therapies, the panel suggests stopping these agents. It suggests the early use of advanced therapies and/or immunomodulator therapy rather than gradual step-up after failure of 5-ASAs.
Dr. James D. Lewis

According to Lewis, the guidance will be useful to both community physicians and highly specialized gastroenterologists. “While few practicing physicians will be able to commit the entirety of the classifications in this guideline to memory, the tool is a quick reference resource to help providers and patients to choose between the many options,” he said.

However, he noted that not all patients and providers may have the same priorities as the guidelines. “There are a few nuances to the methods of the AGA guidelines. For example, the panel prioritized efficacy over safety because the incidence of serious adverse events secondary to medications is relatively rare.”

Lewis also noted that the way the panel classified higher-, intermediate-, and lower-efficacy medications sometimes produced surprising results. “For example, among patients naive to advanced therapies, the IL [interleukin]–23 inhibitors risankizumab and guselkumab were classified as higher efficacy, while the IL-12/23 inhibitor ustekinumab was considered intermediate efficacy,” he said. “These were reversed for patients with prior exposure to advanced therapies, where ustekinumab was considered higher efficacy and all three IL-23 inhibitors were considered intermediate efficacy.”

 

The Future

The panel identified several knowledge gaps that future studies should address. These include a paucity of head-to-head comparison trials, including active comparators to accurately inform positioning of different treatments and therapeutic mechanisms.

The panelists also noted a literature gap on the efficacy of different therapies in the setting of failure or intolerance to non-TNF antagonist advanced therapy, which could be relevant to drugs that may have a greater overlap in their therapeutic mechanisms — for instance, anti-trafficking agents.

They pointed to a paucity of data on how predictive models can inform future treatment selection in the real-world setting. “There is clearly a need for identifying biomarkers predictive of response to individual therapies, to facilitate optimal choice of therapies,” they wrote.

The panel also recognized that novel therapeutic strategies may soon be in use, including combination advanced therapy or episodic use of nonimmunogenic advanced therapies such as small molecules. “Further primary data are required to accurately inform the positioning of such strategies,” they wrote.

These guidelines were fully funded by the AGA Institute. Singh and Agrawal are supported by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), and Ananthakrishnan is supported by the NIDDK, as well as by the Leona M. and Harry B. Helmsley Charitable Trust and the Chleck Family Foundation. Singh disclosed Institutional research grants from Pfizer. Agrawal reported consulting for Douglas Pharmaceuticals. Several coauthors disclosed receiving consulting fees and/or research support from various private companies in the healthcare field. One author reported stock ownership stock in Exact Sciences. Lewis reported consulting, advisory board service, or data monitoring for Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Gilead, Janssen Pharmaceuticals, Merck, Pfizer, Protagonist Therapeutics, and Sanofi. He received research funding or in-kind support from Nestle Health Science, Takeda, Janssen Pharmaceuticals, AbbVie, and Eli Lilly and has had educational grants from Janssen.

A version of this article appeared on Medscape.com.

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In a rapidly expanding therapeutic landscape, the American Gastroenterological Association (AGA) has issued updated practice guidelines for the pharmacological management of moderate to severe ulcerative colitis (UC) in adult outpatients.

“These are the first living guidelines published by a GI society, highlighting the interest and need to provide timely guidance to all stakeholders in a rapidly evolving field,” first author Siddharth Singh, MD, of the Division of Gastroenterology in the Department of Medicine at University of California, San Diego, said in an interview. Living guidance allows for ongoing revision of individual recommendations as new data emerge. Nearly 2 million Americans have UC.

 

Dr. Manasi Agrawal

Issued in Gastroenterology and updating the last guidance in 2020, the recommendations suggest more efficacious drugs should be used sooner. “Early use of advanced therapies including biologics and small-molecule drugs are more effective than 5-aminosalicylates [5-ASAs] or thiopurines and methotrexate for most patients with moderate to severe UC and those with poor prognostic factors,” coauthor and gastroenterologist Manasi Agrawal, MD, MS, an assistant professor of medicine at Icahn School of Medicine at Mount Sinai in New York City, said in an interview.

“We provide a practical guidance based on best-available evidence to make it easy for the treating clinician to make informed choices from the multiplicity of available treatments for UC,” added guidelines coauthor Ashwin Ananthakrishnan, MBBS, MPH, AGAF, a gastroenterologist at Massachusetts General Hospital in Boston.

 

Dr. Ashwin N. Ananthakrishnan

The comprehensive, patient-centered document comes with this caveat from the AGA panel: “These guidelines are meant to be broad recommendations for management of patients with moderate to severe UC and are not intended to address the intricacies of individual patients,” they wrote. “Provider experience and patient values and preferences can inform treating providers and patients to reasonably choose alternative treatment options.”

One gastroenterologist who has been eagerly awaiting these guidelines but not involved in the panel is James D. Lewis, MD, MSCE, AGAF, a professor of medicine and epidemiology at Perelman School of Medicine at the University of Pennsylvania, Philadelphia. “The choice of medications for moderately to severely active UC has expanded tremendously in the past few years,” he said in an interview. “This resulted in the dismantling of the historical therapeutic pyramid.” And while there are many more treatment options, knowing which medication to use for which patient and in which sequence has become much more complicated. 

“These guidelines will be extremely helpful for clinicians trying to navigate this new era of UC care,” he said.

The guidelines also outline implementation considerations for optimal use in different scenarios. “Key considerations include patient-related factors such as age, frailty, other health conditions, consideration for pregnancy, patient preferences, and access to healthcare,” Agrawal said.

 

Specifics

Overall, the guidance recommends advanced or immunomodulatory therapy after failure of 5-ASAs rather than a step-up approach. Moderate to severe disease is defined as a Mayo endoscopic severity subscore of 2 or 3.

The recommendation may also apply to mild disease in the presence of a high burden of inflammation and a poor prognosis or steroid dependence or resistance.

The AGA guideline panelists took account of differences in treatment efficacy between drugs within the same therapeutic class and made their recommendations by specific drugs rather than therapy class.

Based on varying degrees of evidence certainty, the AGA recommends or suggests the following management specifics in adult outpatients with moderate to severe disease:

  • Any of the following is recommended over no treatment: infliximab (Remicade), golimumab (Simponi), vedolizumab (Entyvio), tofacitinib (Xeljanz), upadacitinib (Rinvoq), ustekinumab (Stelara), ozanimod (Zeposia), etrasimod (Velsipity), risankizumab (Skyrizi), and guselkumab (Tremfya).
  • Adalimumab (Humira), filgotinib (Jyseleca), and mirikizumab (Omvoh) are suggested over no treatment.
  • Biosimilars to infliximabadalimumab, and ustekinumab can be considered of equivalent efficacy to their originator drugs.
  • For patients naive to advanced therapies, the AGA panel proposes using a higher-efficacy medication (eg, infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, and guselkumab) or an intermediate-efficacy medication (golimumab, ustekinumab, tofacitinib, filgotinib, and mirikizumab) rather than a lower-efficacy medication such as adalimumab.
  • In patients previously exposed to advanced therapy, particularly tumor necrosis factor (TNF)–alpha antagonists, the panel suggests using a higher-efficacy medication (tofacitinib, upadacitinib, and ustekinumab) or an intermediate-efficacy agent (filgotinib, mirikizumab, risankizumab, and guselkumab) over a lower-efficacy medication (adalimumab, vedolizumab, ozanimod, and etrasimod).
  • The panel suggests against the use of thiopurine monotherapy for inducing remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
  • The panel suggests against the use of methotrexate monotherapy for induction or maintenance of remission.
  • Infliximab, adalimumab, and golimumab in combination with an immunomodulator are suggested over monotherapy.
  • The panel makes no recommendation for or against non-TNF antagonist biologics in combination with an immunomodulator over non-TNF biologics alone.
  • For patients in corticosteroid-free clinical remission for at least 6 months on combination therapy with TNF antagonists and immunomodulators, the panel suggests against withdrawing TNF antagonists but makes no recommendation for or against withdrawing immunomodulators.
  • For those who have failed 5-ASAs and have escalated to immunomodulators or advanced therapies, the panel suggests stopping these agents. It suggests the early use of advanced therapies and/or immunomodulator therapy rather than gradual step-up after failure of 5-ASAs.
Dr. James D. Lewis

According to Lewis, the guidance will be useful to both community physicians and highly specialized gastroenterologists. “While few practicing physicians will be able to commit the entirety of the classifications in this guideline to memory, the tool is a quick reference resource to help providers and patients to choose between the many options,” he said.

However, he noted that not all patients and providers may have the same priorities as the guidelines. “There are a few nuances to the methods of the AGA guidelines. For example, the panel prioritized efficacy over safety because the incidence of serious adverse events secondary to medications is relatively rare.”

Lewis also noted that the way the panel classified higher-, intermediate-, and lower-efficacy medications sometimes produced surprising results. “For example, among patients naive to advanced therapies, the IL [interleukin]–23 inhibitors risankizumab and guselkumab were classified as higher efficacy, while the IL-12/23 inhibitor ustekinumab was considered intermediate efficacy,” he said. “These were reversed for patients with prior exposure to advanced therapies, where ustekinumab was considered higher efficacy and all three IL-23 inhibitors were considered intermediate efficacy.”

 

The Future

The panel identified several knowledge gaps that future studies should address. These include a paucity of head-to-head comparison trials, including active comparators to accurately inform positioning of different treatments and therapeutic mechanisms.

The panelists also noted a literature gap on the efficacy of different therapies in the setting of failure or intolerance to non-TNF antagonist advanced therapy, which could be relevant to drugs that may have a greater overlap in their therapeutic mechanisms — for instance, anti-trafficking agents.

They pointed to a paucity of data on how predictive models can inform future treatment selection in the real-world setting. “There is clearly a need for identifying biomarkers predictive of response to individual therapies, to facilitate optimal choice of therapies,” they wrote.

The panel also recognized that novel therapeutic strategies may soon be in use, including combination advanced therapy or episodic use of nonimmunogenic advanced therapies such as small molecules. “Further primary data are required to accurately inform the positioning of such strategies,” they wrote.

These guidelines were fully funded by the AGA Institute. Singh and Agrawal are supported by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), and Ananthakrishnan is supported by the NIDDK, as well as by the Leona M. and Harry B. Helmsley Charitable Trust and the Chleck Family Foundation. Singh disclosed Institutional research grants from Pfizer. Agrawal reported consulting for Douglas Pharmaceuticals. Several coauthors disclosed receiving consulting fees and/or research support from various private companies in the healthcare field. One author reported stock ownership stock in Exact Sciences. Lewis reported consulting, advisory board service, or data monitoring for Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Gilead, Janssen Pharmaceuticals, Merck, Pfizer, Protagonist Therapeutics, and Sanofi. He received research funding or in-kind support from Nestle Health Science, Takeda, Janssen Pharmaceuticals, AbbVie, and Eli Lilly and has had educational grants from Janssen.

A version of this article appeared on Medscape.com.

In a rapidly expanding therapeutic landscape, the American Gastroenterological Association (AGA) has issued updated practice guidelines for the pharmacological management of moderate to severe ulcerative colitis (UC) in adult outpatients.

“These are the first living guidelines published by a GI society, highlighting the interest and need to provide timely guidance to all stakeholders in a rapidly evolving field,” first author Siddharth Singh, MD, of the Division of Gastroenterology in the Department of Medicine at University of California, San Diego, said in an interview. Living guidance allows for ongoing revision of individual recommendations as new data emerge. Nearly 2 million Americans have UC.

 

Dr. Manasi Agrawal

Issued in Gastroenterology and updating the last guidance in 2020, the recommendations suggest more efficacious drugs should be used sooner. “Early use of advanced therapies including biologics and small-molecule drugs are more effective than 5-aminosalicylates [5-ASAs] or thiopurines and methotrexate for most patients with moderate to severe UC and those with poor prognostic factors,” coauthor and gastroenterologist Manasi Agrawal, MD, MS, an assistant professor of medicine at Icahn School of Medicine at Mount Sinai in New York City, said in an interview.

“We provide a practical guidance based on best-available evidence to make it easy for the treating clinician to make informed choices from the multiplicity of available treatments for UC,” added guidelines coauthor Ashwin Ananthakrishnan, MBBS, MPH, AGAF, a gastroenterologist at Massachusetts General Hospital in Boston.

 

Dr. Ashwin N. Ananthakrishnan

The comprehensive, patient-centered document comes with this caveat from the AGA panel: “These guidelines are meant to be broad recommendations for management of patients with moderate to severe UC and are not intended to address the intricacies of individual patients,” they wrote. “Provider experience and patient values and preferences can inform treating providers and patients to reasonably choose alternative treatment options.”

One gastroenterologist who has been eagerly awaiting these guidelines but not involved in the panel is James D. Lewis, MD, MSCE, AGAF, a professor of medicine and epidemiology at Perelman School of Medicine at the University of Pennsylvania, Philadelphia. “The choice of medications for moderately to severely active UC has expanded tremendously in the past few years,” he said in an interview. “This resulted in the dismantling of the historical therapeutic pyramid.” And while there are many more treatment options, knowing which medication to use for which patient and in which sequence has become much more complicated. 

“These guidelines will be extremely helpful for clinicians trying to navigate this new era of UC care,” he said.

The guidelines also outline implementation considerations for optimal use in different scenarios. “Key considerations include patient-related factors such as age, frailty, other health conditions, consideration for pregnancy, patient preferences, and access to healthcare,” Agrawal said.

 

Specifics

Overall, the guidance recommends advanced or immunomodulatory therapy after failure of 5-ASAs rather than a step-up approach. Moderate to severe disease is defined as a Mayo endoscopic severity subscore of 2 or 3.

The recommendation may also apply to mild disease in the presence of a high burden of inflammation and a poor prognosis or steroid dependence or resistance.

The AGA guideline panelists took account of differences in treatment efficacy between drugs within the same therapeutic class and made their recommendations by specific drugs rather than therapy class.

Based on varying degrees of evidence certainty, the AGA recommends or suggests the following management specifics in adult outpatients with moderate to severe disease:

  • Any of the following is recommended over no treatment: infliximab (Remicade), golimumab (Simponi), vedolizumab (Entyvio), tofacitinib (Xeljanz), upadacitinib (Rinvoq), ustekinumab (Stelara), ozanimod (Zeposia), etrasimod (Velsipity), risankizumab (Skyrizi), and guselkumab (Tremfya).
  • Adalimumab (Humira), filgotinib (Jyseleca), and mirikizumab (Omvoh) are suggested over no treatment.
  • Biosimilars to infliximabadalimumab, and ustekinumab can be considered of equivalent efficacy to their originator drugs.
  • For patients naive to advanced therapies, the AGA panel proposes using a higher-efficacy medication (eg, infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, and guselkumab) or an intermediate-efficacy medication (golimumab, ustekinumab, tofacitinib, filgotinib, and mirikizumab) rather than a lower-efficacy medication such as adalimumab.
  • In patients previously exposed to advanced therapy, particularly tumor necrosis factor (TNF)–alpha antagonists, the panel suggests using a higher-efficacy medication (tofacitinib, upadacitinib, and ustekinumab) or an intermediate-efficacy agent (filgotinib, mirikizumab, risankizumab, and guselkumab) over a lower-efficacy medication (adalimumab, vedolizumab, ozanimod, and etrasimod).
  • The panel suggests against the use of thiopurine monotherapy for inducing remission but suggests thiopurine monotherapy over no treatment for maintenance of (typically corticosteroid-induced) remission.
  • The panel suggests against the use of methotrexate monotherapy for induction or maintenance of remission.
  • Infliximab, adalimumab, and golimumab in combination with an immunomodulator are suggested over monotherapy.
  • The panel makes no recommendation for or against non-TNF antagonist biologics in combination with an immunomodulator over non-TNF biologics alone.
  • For patients in corticosteroid-free clinical remission for at least 6 months on combination therapy with TNF antagonists and immunomodulators, the panel suggests against withdrawing TNF antagonists but makes no recommendation for or against withdrawing immunomodulators.
  • For those who have failed 5-ASAs and have escalated to immunomodulators or advanced therapies, the panel suggests stopping these agents. It suggests the early use of advanced therapies and/or immunomodulator therapy rather than gradual step-up after failure of 5-ASAs.
Dr. James D. Lewis

According to Lewis, the guidance will be useful to both community physicians and highly specialized gastroenterologists. “While few practicing physicians will be able to commit the entirety of the classifications in this guideline to memory, the tool is a quick reference resource to help providers and patients to choose between the many options,” he said.

However, he noted that not all patients and providers may have the same priorities as the guidelines. “There are a few nuances to the methods of the AGA guidelines. For example, the panel prioritized efficacy over safety because the incidence of serious adverse events secondary to medications is relatively rare.”

Lewis also noted that the way the panel classified higher-, intermediate-, and lower-efficacy medications sometimes produced surprising results. “For example, among patients naive to advanced therapies, the IL [interleukin]–23 inhibitors risankizumab and guselkumab were classified as higher efficacy, while the IL-12/23 inhibitor ustekinumab was considered intermediate efficacy,” he said. “These were reversed for patients with prior exposure to advanced therapies, where ustekinumab was considered higher efficacy and all three IL-23 inhibitors were considered intermediate efficacy.”

 

The Future

The panel identified several knowledge gaps that future studies should address. These include a paucity of head-to-head comparison trials, including active comparators to accurately inform positioning of different treatments and therapeutic mechanisms.

The panelists also noted a literature gap on the efficacy of different therapies in the setting of failure or intolerance to non-TNF antagonist advanced therapy, which could be relevant to drugs that may have a greater overlap in their therapeutic mechanisms — for instance, anti-trafficking agents.

They pointed to a paucity of data on how predictive models can inform future treatment selection in the real-world setting. “There is clearly a need for identifying biomarkers predictive of response to individual therapies, to facilitate optimal choice of therapies,” they wrote.

The panel also recognized that novel therapeutic strategies may soon be in use, including combination advanced therapy or episodic use of nonimmunogenic advanced therapies such as small molecules. “Further primary data are required to accurately inform the positioning of such strategies,” they wrote.

These guidelines were fully funded by the AGA Institute. Singh and Agrawal are supported by the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), and Ananthakrishnan is supported by the NIDDK, as well as by the Leona M. and Harry B. Helmsley Charitable Trust and the Chleck Family Foundation. Singh disclosed Institutional research grants from Pfizer. Agrawal reported consulting for Douglas Pharmaceuticals. Several coauthors disclosed receiving consulting fees and/or research support from various private companies in the healthcare field. One author reported stock ownership stock in Exact Sciences. Lewis reported consulting, advisory board service, or data monitoring for Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galapagos, Gilead, Janssen Pharmaceuticals, Merck, Pfizer, Protagonist Therapeutics, and Sanofi. He received research funding or in-kind support from Nestle Health Science, Takeda, Janssen Pharmaceuticals, AbbVie, and Eli Lilly and has had educational grants from Janssen.

A version of this article appeared on Medscape.com.

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Spinal Cord Stimulation Promising for Chronic Back, Leg Pain

Article Type
Changed
Wed, 11/27/2024 - 02:21

TOPLINE:

Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.

METHODOLOGY:

  • Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
  • More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
  • Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
  • Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
  • The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.

TAKEAWAY:

  • Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
  • Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
  • Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
  • Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.

IN PRACTICE:

“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.

SOURCE:

The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.

DISCLOSURES:

This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.

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.

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TOPLINE:

Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.

METHODOLOGY:

  • Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
  • More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
  • Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
  • Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
  • The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.

TAKEAWAY:

  • Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
  • Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
  • Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
  • Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.

IN PRACTICE:

“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.

SOURCE:

The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.

DISCLOSURES:

This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.

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:

Spinal cord stimulation (SCS) therapies for chronic back and/or leg pain is superior to conventional medical management (CMM) for reduced pain intensity and functional disability, new research suggests.

METHODOLOGY:

  • Researchers performed a systematic review and network meta-analysis of 13 randomized clinical trials that compared conventional and novel SCS therapies with CMM.
  • More than 1500 adults with chronic back and/or leg pain and no past history of receiving SCS therapies were included.
  • Novel therapies included high frequency, burst, differential target multiplexed, and closed-loop SCS; conventional therapies included tonic SCS wave forms.
  • Study outcomes included pain intensity in the back and in the leg, proportion of patients achieving at least 50% pain reduction in the back and in the leg, quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) index, and functional disability on the Oswestry Disability Index.
  • The analysis included data from multiple follow-up points at 3, 6, 12, and 24 months, with 6-month data being those from the longest mutually reported timepoint across all outcomes.

TAKEAWAY:

  • Both conventional and novel SCS therapies demonstrated superior efficacy vs CMM in pain reduction, but the novel SCS therapies were more likely to provide ≥ 50% reduction in back pain (odds ratio, 8.76; 95% credible interval [CrI], 3.84-22.31).
  • Both SCS therapies showed a significant reduction in pain intensity, with novel SCS providing the greatest mean difference (MD) for back pain (–2.34; 95% CrI, –2.96 to –1.73) and lower leg pain (MD, –4.01; 95% CrI, –5.31 to –2.75).
  • Quality of life improved with both types of SCS therapies, with novel SCS therapies yielding the highest MD (0.17; 95% CrI, 0.13-0.21) in EQ-5D index score.
  • Conventional SCS showed greater improvement in functionality vs CMM, yielding the lowest MD (–7.10; 95% CrI, –10.91 to –3.36) in Oswestry Disability Index score.

IN PRACTICE:

“We found that SCS was associated with improved pain and QOL [quality of life] and reduced disability, compared with CMM, after 6 months of follow-up. These findings highlight the potential of SCS therapies as an effective and valuable option in chronic pain management,” the investigators wrote.

SOURCE:

The study was led by Frank J.P.M. Huygen, PhD, MD, Erasmus Medical Center, Rotterdam, the Netherlands. It was published online in JAMA Network Open.

LIMITATIONS:

The lack of randomized clinical trials with long-term follow-up data restricted the inclusion of extended outcome assessments. Most included studies showed a high risk for bias. Safety estimates could not be evaluated as adverse events were only reported as procedure-related outcomes, which are not applicable for CMM. Additionally, the network meta-analytical approach, which combined evidence from studies with varying patient eligibility criteria, may have introduced bias because of between-study heterogeneity.

DISCLOSURES:

This study was funded by Medtronic. Huygen reported receiving personal fees from Abbott, Saluda, and Grunenthal outside the submitted work. The four other authors reported receiving funding from Medtronic.

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.

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