Obesity

Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association.

The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese.

The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association.

Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented.

“There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.”
 

Clarity on polysomnography

For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr. Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.”

The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring.

In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.”

Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote.

Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.

Risk factors for OSA in children

The statement also reviewed risk factors for OSA, among them obesity, particularly among children younger than 6 years. Other risk factors include upper and lower airway disease, hypotonia, parental history of hyperplasia of the adenoids and tonsils, craniofacial malformations, and neuromuscular disorders. However, the committee cited “limited data” to support that children with congenital heart disease may be at greater risk for OSA and sleep-disordered breathing (SDB).

Black children are at significantly greater risk, and socioeconomic factors “may be potential confounders,” the committee stated. Other risk factors include allergic rhinitis and sickle cell disease.

But the statement underscores that “obesity is the main risk factor” for OSA in children and adolescents, and that the presence of increased inflammation may explain this relationship. Steroids may alleviate these symptoms, even in nonobese children, and removal of the adenoids or tonsils is an option to reduce inflammation in children with OSA.

“Obesity is a significant risk factor for sleep disturbances and obstructive sleep apnea, and the severity of sleep apnea may be improved by weight-loss interventions, which then improves metabolic syndrome factors such as insulin sensitivity,” Dr. Baker-Smith said. “We need to increase awareness about how the rising prevalence of obesity may be impacting sleep quality in kids and recognize sleep-disordered breathing as something that could contribute to risks for hypertension and later cardiovascular disease.”

Children in whom OSA is suspected should also undergo screening for metabolic syndrome, and central nervous system and behavioral disorders.
 

Cardiovascular risks

The statement explores the connection between cardiovascular complications and SDB and OSA in depth.

“Inadequate sleep duration of < 5 hours per night in children and adolescents has been linked to an increased risk of hypertension and is also associated with an increased prevalence of obesity,” the committee wrote.

However, the statement left one question hanging: whether OSA alone or obesity cause higher BP in younger patients with OSA. But the committee concluded that BP levels increase with the severity of OSA, although the effects can vary with age. OSA in children peaks between ages 2 and 8, corresponding to the peak prevalence of hypertrophy of the tonsils and adenoids. Children aged 10-11 with more severe OSA may have BP dysregulation, while older adolescents develop higher sustained BP. Obesity may be a confounder for daytime BP elevations, while nighttime hypertension depends less on obesity and more on OSA severity.

“OSA is associated with abnormal BP in youth and, in particular, higher nighttime blood pressures and loss of the normal decline in BP that should occur during sleep,” Dr. Baker-Smith said. “Children with OSA appear to have higher BP than controls during both sleep and wake times, and BP levels increase with increasing severity of OSA.”

Nonetheless, children with OSA are at greater risk for other cardiovascular problems. Left ventricular hypertrophy may be a secondary outcome. “The presence of obstructive sleep apnea in children is associated with an 11-fold increased risk for LVH in children, a relationship not seen in the presence of primary snoring alone,” Dr. Baker-Smith said.

Dr. Baker-Smith had no relevant disclosures. Coauthor Amal Isaiah, MD, is coinventor of an imaging system for sleep apnea and receives royalties from the University of Maryland. The other coauthors have no relevant financial relationships to disclose.

cardnews@mdedge.com

Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association.

The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese.

The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association.

Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented.

“There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.”
 

Clarity on polysomnography

For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr. Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.”

The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring.

In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.”

Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote.

Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.

Risk factors for OSA in children

The statement also reviewed risk factors for OSA, among them obesity, particularly among children younger than 6 years. Other risk factors include upper and lower airway disease, hypotonia, parental history of hyperplasia of the adenoids and tonsils, craniofacial malformations, and neuromuscular disorders. However, the committee cited “limited data” to support that children with congenital heart disease may be at greater risk for OSA and sleep-disordered breathing (SDB).

Black children are at significantly greater risk, and socioeconomic factors “may be potential confounders,” the committee stated. Other risk factors include allergic rhinitis and sickle cell disease.

But the statement underscores that “obesity is the main risk factor” for OSA in children and adolescents, and that the presence of increased inflammation may explain this relationship. Steroids may alleviate these symptoms, even in nonobese children, and removal of the adenoids or tonsils is an option to reduce inflammation in children with OSA.

“Obesity is a significant risk factor for sleep disturbances and obstructive sleep apnea, and the severity of sleep apnea may be improved by weight-loss interventions, which then improves metabolic syndrome factors such as insulin sensitivity,” Dr. Baker-Smith said. “We need to increase awareness about how the rising prevalence of obesity may be impacting sleep quality in kids and recognize sleep-disordered breathing as something that could contribute to risks for hypertension and later cardiovascular disease.”

Children in whom OSA is suspected should also undergo screening for metabolic syndrome, and central nervous system and behavioral disorders.
 

Cardiovascular risks

The statement explores the connection between cardiovascular complications and SDB and OSA in depth.

“Inadequate sleep duration of < 5 hours per night in children and adolescents has been linked to an increased risk of hypertension and is also associated with an increased prevalence of obesity,” the committee wrote.

However, the statement left one question hanging: whether OSA alone or obesity cause higher BP in younger patients with OSA. But the committee concluded that BP levels increase with the severity of OSA, although the effects can vary with age. OSA in children peaks between ages 2 and 8, corresponding to the peak prevalence of hypertrophy of the tonsils and adenoids. Children aged 10-11 with more severe OSA may have BP dysregulation, while older adolescents develop higher sustained BP. Obesity may be a confounder for daytime BP elevations, while nighttime hypertension depends less on obesity and more on OSA severity.

“OSA is associated with abnormal BP in youth and, in particular, higher nighttime blood pressures and loss of the normal decline in BP that should occur during sleep,” Dr. Baker-Smith said. “Children with OSA appear to have higher BP than controls during both sleep and wake times, and BP levels increase with increasing severity of OSA.”

Nonetheless, children with OSA are at greater risk for other cardiovascular problems. Left ventricular hypertrophy may be a secondary outcome. “The presence of obstructive sleep apnea in children is associated with an 11-fold increased risk for LVH in children, a relationship not seen in the presence of primary snoring alone,” Dr. Baker-Smith said.

Dr. Baker-Smith had no relevant disclosures. Coauthor Amal Isaiah, MD, is coinventor of an imaging system for sleep apnea and receives royalties from the University of Maryland. The other coauthors have no relevant financial relationships to disclose.

cardnews@mdedge.com

Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association.

The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese.

The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association.

Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented.

“There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.”
 

Clarity on polysomnography

For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr. Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.”

The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring.

In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.”

Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote.

Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.

Risk factors for OSA in children

The statement also reviewed risk factors for OSA, among them obesity, particularly among children younger than 6 years. Other risk factors include upper and lower airway disease, hypotonia, parental history of hyperplasia of the adenoids and tonsils, craniofacial malformations, and neuromuscular disorders. However, the committee cited “limited data” to support that children with congenital heart disease may be at greater risk for OSA and sleep-disordered breathing (SDB).

Black children are at significantly greater risk, and socioeconomic factors “may be potential confounders,” the committee stated. Other risk factors include allergic rhinitis and sickle cell disease.

But the statement underscores that “obesity is the main risk factor” for OSA in children and adolescents, and that the presence of increased inflammation may explain this relationship. Steroids may alleviate these symptoms, even in nonobese children, and removal of the adenoids or tonsils is an option to reduce inflammation in children with OSA.

“Obesity is a significant risk factor for sleep disturbances and obstructive sleep apnea, and the severity of sleep apnea may be improved by weight-loss interventions, which then improves metabolic syndrome factors such as insulin sensitivity,” Dr. Baker-Smith said. “We need to increase awareness about how the rising prevalence of obesity may be impacting sleep quality in kids and recognize sleep-disordered breathing as something that could contribute to risks for hypertension and later cardiovascular disease.”

Children in whom OSA is suspected should also undergo screening for metabolic syndrome, and central nervous system and behavioral disorders.
 

Cardiovascular risks

The statement explores the connection between cardiovascular complications and SDB and OSA in depth.

“Inadequate sleep duration of < 5 hours per night in children and adolescents has been linked to an increased risk of hypertension and is also associated with an increased prevalence of obesity,” the committee wrote.

However, the statement left one question hanging: whether OSA alone or obesity cause higher BP in younger patients with OSA. But the committee concluded that BP levels increase with the severity of OSA, although the effects can vary with age. OSA in children peaks between ages 2 and 8, corresponding to the peak prevalence of hypertrophy of the tonsils and adenoids. Children aged 10-11 with more severe OSA may have BP dysregulation, while older adolescents develop higher sustained BP. Obesity may be a confounder for daytime BP elevations, while nighttime hypertension depends less on obesity and more on OSA severity.

“OSA is associated with abnormal BP in youth and, in particular, higher nighttime blood pressures and loss of the normal decline in BP that should occur during sleep,” Dr. Baker-Smith said. “Children with OSA appear to have higher BP than controls during both sleep and wake times, and BP levels increase with increasing severity of OSA.”

Nonetheless, children with OSA are at greater risk for other cardiovascular problems. Left ventricular hypertrophy may be a secondary outcome. “The presence of obstructive sleep apnea in children is associated with an 11-fold increased risk for LVH in children, a relationship not seen in the presence of primary snoring alone,” Dr. Baker-Smith said.

Dr. Baker-Smith had no relevant disclosures. Coauthor Amal Isaiah, MD, is coinventor of an imaging system for sleep apnea and receives royalties from the University of Maryland. The other coauthors have no relevant financial relationships to disclose.

cardnews@mdedge.com

The prevalence of youth-onset diabetes in the United States rose significantly from 2001 to 2017, with rates of type 2 diabetes climbing disproportionately among racial/ethnic minorities, according to investigators.

In individuals aged 19 years or younger, prevalence rates of type 1 and type 2 diabetes increased 45.1% and 95.3%, respectively, reported lead author Jean M. Lawrence, ScD, MPH, MSSA, program director of the division of diabetes, endocrinology, and metabolic diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md., and colleagues.

“Elucidating differences in diabetes prevalence trends by diabetes type and demographic characteristics is essential to describe the burden of disease and to estimate current and future resource needs,” Dr. Lawrence and colleagues wrote in JAMA.

The retrospective analysis was a part of the ongoing SEARCH study, which includes data from individuals in six areas across the United States: Colorado, California, Ohio, South Carolina, Washington state, and Arizona/New Mexico (Indian Health Services). In the present report, three prevalence years were evaluated: 2001, 2009, and 2017. For each year, approximately 3.5 million youths were included. Findings were reported in terms of diabetes type, race/ethnicity, age at diagnosis, and sex.

Absolute prevalence of type 1 diabetes per 1,000 youths increased from 1.48 in 2001, to 1.93 in 2009, and finally 2.15 in 2017. Across the 16-year period, this represents an absolute increase of 0.67 (95% confidence interval, 0.64-0.70), and a relative increase of 45.1% (95% CI, 40.0%-50.4%). In absolute terms, prevalence increased most among non-Hispanic White (0.93 per 1,000) and non-Hispanic Black (0.89 per 1,000) youths.

While type 2 diabetes was comparatively less common than type 1 diabetes, absolute prevalence per 1,000 youths increased to a greater degree, rising from 0.34 in 2001 to 0.46 in 2009 and to 0.67 in 2017. This amounts to relative increase across the period of 95.3% (95% CI, 77.0%-115.4%). Absolute increases were disproportionate among racial/ethnic minorities, particularly Black and Hispanic youths, who had absolute increases per 1,000 youths of 0.85 (95% CI, 0.74-0.97) and 0.57 (95% CI, 0.51-0.64), respectively, compared with 0.05 (95% CI, 0.03-0.07) for White youths.

“Increases [among Black and Hispanic youths] were not linear,” the investigators noted. “Hispanic youths had a significantly greater increase in the first interval compared with the second interval, while Black youths had no significant increase in the first interval and a significant increase in the second interval.”

Dr. Lawrence and colleagues offered several possible factors driving these trends in type 2 diabetes.

“Changes in anthropometric risk factors appear to play a significant role,” they wrote, noting that “Black and Mexican American teenagers experienced the greatest increase in prevalence of obesity/severe obesity from 1999 to 2018, which may contribute to race and ethnicity differences. Other contributing factors may include increases in exposure to maternal obesity and diabetes (gestational and type 2 diabetes) and exposure to environmental chemicals.”

According to Megan Kelsey, MD, associate professor of pediatric endocrinology, director of lifestyle medicine endocrinology, and medical director of the bariatric surgery center at Children’s Hospital Colorado, Aurora, the increased rates of type 2 diabetes reported by the study are alarming, yet they pale in comparison with what’s been happening since the pandemic began.

“Individual institutions have reported anywhere between a 50% – which is basically what we’re seeing at our hospital – to a 300% increase in new diagnoses [of type 2 diabetes] in a single-year time period,” Dr. Kelsey said in an interview. “So what is reported [in the present study] doesn’t even get at what’s been going on over the past year and a half.”

Dr. Kelsey offered some speculative drivers of this recent surge in cases, including stress, weight gain caused by sedentary behavior and more access to food, and the possibility that SARS-CoV-2 may infect pancreatic islet beta cells, thereby interfering with insulin production.

Type 2 diabetes is particularly concerning among young people, Dr. Kelsey noted, as it is more challenging to manage than adult-onset disease.

Young patients “also develop complications much sooner than you’d expect,” she added. “So we really need to understand why these rates are increasing, how we can identify kids at risk, and how we can better prevent it, so we aren’t stuck with a disease that’s really difficult to treat.”

To this end, the NIH recently opened applications for investigators to participate in a prospective longitudinal study of youth-onset type 2 diabetes. Young people at risk of diabetes will be followed through puberty, a period of increased risk, according to Dr. Kelsey.

“The goal will be to take kids who don’t yet have [type 2] diabetes, but are at risk, and try to better understand, as some of them progress to developing diabetes, what is going on,” Dr. Kelsey said. “What are other factors that we can use to better predict who’s going to develop diabetes? And can we use the information from this [upcoming] study to understand how to better prevent it? Because nothing that has been tried so far has worked.”

The study was supported by the Centers for Disease Control and Prevention, NIDDK, and others. The investigators and Dr. Kelsey reported no conflicts of interest.

The prevalence of youth-onset diabetes in the United States rose significantly from 2001 to 2017, with rates of type 2 diabetes climbing disproportionately among racial/ethnic minorities, according to investigators.

In individuals aged 19 years or younger, prevalence rates of type 1 and type 2 diabetes increased 45.1% and 95.3%, respectively, reported lead author Jean M. Lawrence, ScD, MPH, MSSA, program director of the division of diabetes, endocrinology, and metabolic diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md., and colleagues.

“Elucidating differences in diabetes prevalence trends by diabetes type and demographic characteristics is essential to describe the burden of disease and to estimate current and future resource needs,” Dr. Lawrence and colleagues wrote in JAMA.

The retrospective analysis was a part of the ongoing SEARCH study, which includes data from individuals in six areas across the United States: Colorado, California, Ohio, South Carolina, Washington state, and Arizona/New Mexico (Indian Health Services). In the present report, three prevalence years were evaluated: 2001, 2009, and 2017. For each year, approximately 3.5 million youths were included. Findings were reported in terms of diabetes type, race/ethnicity, age at diagnosis, and sex.

Absolute prevalence of type 1 diabetes per 1,000 youths increased from 1.48 in 2001, to 1.93 in 2009, and finally 2.15 in 2017. Across the 16-year period, this represents an absolute increase of 0.67 (95% confidence interval, 0.64-0.70), and a relative increase of 45.1% (95% CI, 40.0%-50.4%). In absolute terms, prevalence increased most among non-Hispanic White (0.93 per 1,000) and non-Hispanic Black (0.89 per 1,000) youths.

While type 2 diabetes was comparatively less common than type 1 diabetes, absolute prevalence per 1,000 youths increased to a greater degree, rising from 0.34 in 2001 to 0.46 in 2009 and to 0.67 in 2017. This amounts to relative increase across the period of 95.3% (95% CI, 77.0%-115.4%). Absolute increases were disproportionate among racial/ethnic minorities, particularly Black and Hispanic youths, who had absolute increases per 1,000 youths of 0.85 (95% CI, 0.74-0.97) and 0.57 (95% CI, 0.51-0.64), respectively, compared with 0.05 (95% CI, 0.03-0.07) for White youths.

“Increases [among Black and Hispanic youths] were not linear,” the investigators noted. “Hispanic youths had a significantly greater increase in the first interval compared with the second interval, while Black youths had no significant increase in the first interval and a significant increase in the second interval.”

Dr. Lawrence and colleagues offered several possible factors driving these trends in type 2 diabetes.

“Changes in anthropometric risk factors appear to play a significant role,” they wrote, noting that “Black and Mexican American teenagers experienced the greatest increase in prevalence of obesity/severe obesity from 1999 to 2018, which may contribute to race and ethnicity differences. Other contributing factors may include increases in exposure to maternal obesity and diabetes (gestational and type 2 diabetes) and exposure to environmental chemicals.”

According to Megan Kelsey, MD, associate professor of pediatric endocrinology, director of lifestyle medicine endocrinology, and medical director of the bariatric surgery center at Children’s Hospital Colorado, Aurora, the increased rates of type 2 diabetes reported by the study are alarming, yet they pale in comparison with what’s been happening since the pandemic began.

“Individual institutions have reported anywhere between a 50% – which is basically what we’re seeing at our hospital – to a 300% increase in new diagnoses [of type 2 diabetes] in a single-year time period,” Dr. Kelsey said in an interview. “So what is reported [in the present study] doesn’t even get at what’s been going on over the past year and a half.”

Dr. Kelsey offered some speculative drivers of this recent surge in cases, including stress, weight gain caused by sedentary behavior and more access to food, and the possibility that SARS-CoV-2 may infect pancreatic islet beta cells, thereby interfering with insulin production.

Type 2 diabetes is particularly concerning among young people, Dr. Kelsey noted, as it is more challenging to manage than adult-onset disease.

Young patients “also develop complications much sooner than you’d expect,” she added. “So we really need to understand why these rates are increasing, how we can identify kids at risk, and how we can better prevent it, so we aren’t stuck with a disease that’s really difficult to treat.”

To this end, the NIH recently opened applications for investigators to participate in a prospective longitudinal study of youth-onset type 2 diabetes. Young people at risk of diabetes will be followed through puberty, a period of increased risk, according to Dr. Kelsey.

“The goal will be to take kids who don’t yet have [type 2] diabetes, but are at risk, and try to better understand, as some of them progress to developing diabetes, what is going on,” Dr. Kelsey said. “What are other factors that we can use to better predict who’s going to develop diabetes? And can we use the information from this [upcoming] study to understand how to better prevent it? Because nothing that has been tried so far has worked.”

The study was supported by the Centers for Disease Control and Prevention, NIDDK, and others. The investigators and Dr. Kelsey reported no conflicts of interest.

The prevalence of youth-onset diabetes in the United States rose significantly from 2001 to 2017, with rates of type 2 diabetes climbing disproportionately among racial/ethnic minorities, according to investigators.

In individuals aged 19 years or younger, prevalence rates of type 1 and type 2 diabetes increased 45.1% and 95.3%, respectively, reported lead author Jean M. Lawrence, ScD, MPH, MSSA, program director of the division of diabetes, endocrinology, and metabolic diseases at the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Md., and colleagues.

“Elucidating differences in diabetes prevalence trends by diabetes type and demographic characteristics is essential to describe the burden of disease and to estimate current and future resource needs,” Dr. Lawrence and colleagues wrote in JAMA.

The retrospective analysis was a part of the ongoing SEARCH study, which includes data from individuals in six areas across the United States: Colorado, California, Ohio, South Carolina, Washington state, and Arizona/New Mexico (Indian Health Services). In the present report, three prevalence years were evaluated: 2001, 2009, and 2017. For each year, approximately 3.5 million youths were included. Findings were reported in terms of diabetes type, race/ethnicity, age at diagnosis, and sex.

Absolute prevalence of type 1 diabetes per 1,000 youths increased from 1.48 in 2001, to 1.93 in 2009, and finally 2.15 in 2017. Across the 16-year period, this represents an absolute increase of 0.67 (95% confidence interval, 0.64-0.70), and a relative increase of 45.1% (95% CI, 40.0%-50.4%). In absolute terms, prevalence increased most among non-Hispanic White (0.93 per 1,000) and non-Hispanic Black (0.89 per 1,000) youths.

While type 2 diabetes was comparatively less common than type 1 diabetes, absolute prevalence per 1,000 youths increased to a greater degree, rising from 0.34 in 2001 to 0.46 in 2009 and to 0.67 in 2017. This amounts to relative increase across the period of 95.3% (95% CI, 77.0%-115.4%). Absolute increases were disproportionate among racial/ethnic minorities, particularly Black and Hispanic youths, who had absolute increases per 1,000 youths of 0.85 (95% CI, 0.74-0.97) and 0.57 (95% CI, 0.51-0.64), respectively, compared with 0.05 (95% CI, 0.03-0.07) for White youths.

“Increases [among Black and Hispanic youths] were not linear,” the investigators noted. “Hispanic youths had a significantly greater increase in the first interval compared with the second interval, while Black youths had no significant increase in the first interval and a significant increase in the second interval.”

Dr. Lawrence and colleagues offered several possible factors driving these trends in type 2 diabetes.

“Changes in anthropometric risk factors appear to play a significant role,” they wrote, noting that “Black and Mexican American teenagers experienced the greatest increase in prevalence of obesity/severe obesity from 1999 to 2018, which may contribute to race and ethnicity differences. Other contributing factors may include increases in exposure to maternal obesity and diabetes (gestational and type 2 diabetes) and exposure to environmental chemicals.”

According to Megan Kelsey, MD, associate professor of pediatric endocrinology, director of lifestyle medicine endocrinology, and medical director of the bariatric surgery center at Children’s Hospital Colorado, Aurora, the increased rates of type 2 diabetes reported by the study are alarming, yet they pale in comparison with what’s been happening since the pandemic began.

“Individual institutions have reported anywhere between a 50% – which is basically what we’re seeing at our hospital – to a 300% increase in new diagnoses [of type 2 diabetes] in a single-year time period,” Dr. Kelsey said in an interview. “So what is reported [in the present study] doesn’t even get at what’s been going on over the past year and a half.”

Dr. Kelsey offered some speculative drivers of this recent surge in cases, including stress, weight gain caused by sedentary behavior and more access to food, and the possibility that SARS-CoV-2 may infect pancreatic islet beta cells, thereby interfering with insulin production.

Type 2 diabetes is particularly concerning among young people, Dr. Kelsey noted, as it is more challenging to manage than adult-onset disease.

Young patients “also develop complications much sooner than you’d expect,” she added. “So we really need to understand why these rates are increasing, how we can identify kids at risk, and how we can better prevent it, so we aren’t stuck with a disease that’s really difficult to treat.”

To this end, the NIH recently opened applications for investigators to participate in a prospective longitudinal study of youth-onset type 2 diabetes. Young people at risk of diabetes will be followed through puberty, a period of increased risk, according to Dr. Kelsey.

“The goal will be to take kids who don’t yet have [type 2] diabetes, but are at risk, and try to better understand, as some of them progress to developing diabetes, what is going on,” Dr. Kelsey said. “What are other factors that we can use to better predict who’s going to develop diabetes? And can we use the information from this [upcoming] study to understand how to better prevent it? Because nothing that has been tried so far has worked.”

The study was supported by the Centers for Disease Control and Prevention, NIDDK, and others. The investigators and Dr. Kelsey reported no conflicts of interest.

The United States Preventive Services Task Force has updated its recommendation on the age of screening for prediabetes and type 2 diabetes in the primary care setting – lowering the age from 40 to 35 years for asymptomatic patients who are overweight or obese and encouraging greater interventions when patients do show a risk.

KatarzynaBialasiewicz/Thinkstock

“The USPSTF concludes with moderate certainty that screening for prediabetes and type 2 diabetes and offering or referring patients with prediabetes to effective preventive interventions has a moderate net benefit,” the task force concludes in its recommendation, published Aug. 24 in JAMA.

“Clinicians should offer or refer patients with prediabetes to effective preventive interventions,” they write.

Experts commenting on the issue strongly emphasize that it’s not just the screening, but the subsequent intervention that is needed to make a difference.

“If young adults newly identified with abnormal glucose metabolism do not receive the needed intensive behavioral change support, screening may provide no benefit,” write Richard W. Grant, MD, MPH, and colleagues in an editorial published with the recommendation.

“Given the role of our obesogenic and physically inactive society in the shift toward earlier onset of diabetes, efforts to increase screening and recognition of abnormal glucose metabolism must be coupled with robust public health measures to address the underlying contributors.”
 

BMI cutoff lower for at-risk ethnic populations

The recommendation, which updates the task force’s 2015 guideline, carries a “B” classification, meaning the USPSTF has high certainty that the net benefit is moderate. It now specifies screening from age 35to 70 for persons classified as overweight (body mass index at least 25) or obese (BMI at least 30) and recommends referral to preventive interventions when patients are found to have prediabetes.

In addition to recommendations of lifestyle changes, such as diet and physical activity, the task force also endorses the diabetes drug metformin as a beneficial intervention in the prevention or delay of diabetes, while noting fewer overall health benefits from metformin than from the lifestyle changes.

A lower BMI cutoff of at least 23 is recommended for diabetes screening of Asian Americans, and, importantly, screening for prediabetes and diabetes should be considered at an even earlier age if the patient is from a population with a disproportionately high prevalence of diabetes, including American Indian/Alaska Native, Black, Hawaiian/Pacific Islander, Hispanic/Latino, the task force recommends.

Screening tests should include fasting plasma glucose, hemoglobin A1c, or an oral glucose tolerance test. Although screening every 3 years “may be a reasonable approach for adults with normal blood glucose levels,” the task force adds that “the optimal screening interval for adults with an initial normal glucose test result is uncertain.”
 

Data review: Few with prediabetes know they have it

The need for the update was prompted by troubling data showing increasing diabetes rates despite early signs that can and should be identified and acted upon in the primary care setting to prevent disease progression.

Data from the Centers for Disease Control and Prevention, for instance, show that while 13% of all U.S. adults 18 years or older have diabetes and 35% meet criteria for prediabetes, as many as 21% of those with diabetes were not aware of or did not report having the disease. Furthermore, only a small fraction – 15% of those with prediabetes – said they had been told by a health professional that they had this condition, the task force notes.

The task force’s final recommendation was based on a systematic review of evidence regarding the screening of asymptomatic, nonpregnant adults and the harms and benefits of interventions, such as physical activity, behavioral counseling, or pharmacotherapy.

Among key evidence supporting the lower age was a 2014 study showing that the number of people necessary to obtain one positive test for diabetes with screening sharply drops from 80 among those aged 30-34 years to just 31 among those aged 36-39.

Opportunistic universal screening of eligible people aged 35 and older would yield a ratio of 1 out of just 15 to spot a positive test, the authors of that study reported.

In addition, a large cohort study in more than 77,000 people with prediabetes strongly links the risk of developing diabetes with increases in A1c level and with increasing BMI.
 

ADA recommendations differ

The new recommendations differ from American Diabetes Association guidelines, which call for diabetes screening at all ages for people who are overweight or obese and who have one or more risk factors, such as physical inactivity or a first-degree relative with diabetes. If results are normal, repeat screening at least every 3 years is recommended.

The ADA further recommends universal screening for all adults 45 years and older, regardless of their risk factors.

For the screening of adults over 45, the ADA recommends using a fasting plasma glucose level, 2-hour plasma glucose level during a 75-g oral glucose tolerance test, or A1c level, regardless of risk factors.

The American Association of Clinical Endocrinology also recommends universal screening for prediabetes and diabetes for all adults 45 years or older, regardless of risk factors, and also advises screening those who have risk factors for diabetes regardless of age.
 

Screening of little benefit without behavior change support

In an interview, Dr. Grant added that broad efforts are essential as those at the practice level have clearly not succeeded.

“The medical model of individual counseling and referral has not really been effective, and so we really need to think in terms of large-scale public health action,” said Dr. Grant, of the division of research, Kaiser Permanente Northern California, Oakland.

His editorial details the sweeping, multifactorial efforts that are needed.

“To turn this recommendation into action – that is, to translate screening activities into improved clinical outcomes – change is needed at the patient-clinician level (recognizing and encouraging eligible individuals to be screened), health care system level (reducing screening barriers and ensuring access to robust lifestyle programs), and societal level (applying effective public health interventions to reduce obesity and increase exercise),” they write.

A top priority has to be a focus on individuals of diverse backgrounds and issues such as access to healthy programs in minority communities, Dr. Grant noted.

“Newly diagnosed adults are more likely to be African-American and Latinx,” he said.

“We really need to invest in healthier communities for low-income, non-White communities to reverse the persistent health care disparities in these communities.”

While the challenges may appear daunting, history shows they are not necessarily insurmountable – as evidenced in the campaign to discourage tobacco smoking.

“National smoking cessation efforts are one example of a mostly successful public health campaign that has made a difference in health behaviors,” Grant noted.

The recommendation is also posted on the USPSTF web site .

Dr. Grant reports receiving grants from the National Institutes of Health and the Patient-Centered Outcomes Research Institute.

The United States Preventive Services Task Force has updated its recommendation on the age of screening for prediabetes and type 2 diabetes in the primary care setting – lowering the age from 40 to 35 years for asymptomatic patients who are overweight or obese and encouraging greater interventions when patients do show a risk.

KatarzynaBialasiewicz/Thinkstock

“The USPSTF concludes with moderate certainty that screening for prediabetes and type 2 diabetes and offering or referring patients with prediabetes to effective preventive interventions has a moderate net benefit,” the task force concludes in its recommendation, published Aug. 24 in JAMA.

“Clinicians should offer or refer patients with prediabetes to effective preventive interventions,” they write.

Experts commenting on the issue strongly emphasize that it’s not just the screening, but the subsequent intervention that is needed to make a difference.

“If young adults newly identified with abnormal glucose metabolism do not receive the needed intensive behavioral change support, screening may provide no benefit,” write Richard W. Grant, MD, MPH, and colleagues in an editorial published with the recommendation.

“Given the role of our obesogenic and physically inactive society in the shift toward earlier onset of diabetes, efforts to increase screening and recognition of abnormal glucose metabolism must be coupled with robust public health measures to address the underlying contributors.”
 

BMI cutoff lower for at-risk ethnic populations

The recommendation, which updates the task force’s 2015 guideline, carries a “B” classification, meaning the USPSTF has high certainty that the net benefit is moderate. It now specifies screening from age 35to 70 for persons classified as overweight (body mass index at least 25) or obese (BMI at least 30) and recommends referral to preventive interventions when patients are found to have prediabetes.

In addition to recommendations of lifestyle changes, such as diet and physical activity, the task force also endorses the diabetes drug metformin as a beneficial intervention in the prevention or delay of diabetes, while noting fewer overall health benefits from metformin than from the lifestyle changes.

A lower BMI cutoff of at least 23 is recommended for diabetes screening of Asian Americans, and, importantly, screening for prediabetes and diabetes should be considered at an even earlier age if the patient is from a population with a disproportionately high prevalence of diabetes, including American Indian/Alaska Native, Black, Hawaiian/Pacific Islander, Hispanic/Latino, the task force recommends.

Screening tests should include fasting plasma glucose, hemoglobin A1c, or an oral glucose tolerance test. Although screening every 3 years “may be a reasonable approach for adults with normal blood glucose levels,” the task force adds that “the optimal screening interval for adults with an initial normal glucose test result is uncertain.”
 

Data review: Few with prediabetes know they have it

The need for the update was prompted by troubling data showing increasing diabetes rates despite early signs that can and should be identified and acted upon in the primary care setting to prevent disease progression.

Data from the Centers for Disease Control and Prevention, for instance, show that while 13% of all U.S. adults 18 years or older have diabetes and 35% meet criteria for prediabetes, as many as 21% of those with diabetes were not aware of or did not report having the disease. Furthermore, only a small fraction – 15% of those with prediabetes – said they had been told by a health professional that they had this condition, the task force notes.

The task force’s final recommendation was based on a systematic review of evidence regarding the screening of asymptomatic, nonpregnant adults and the harms and benefits of interventions, such as physical activity, behavioral counseling, or pharmacotherapy.

Among key evidence supporting the lower age was a 2014 study showing that the number of people necessary to obtain one positive test for diabetes with screening sharply drops from 80 among those aged 30-34 years to just 31 among those aged 36-39.

Opportunistic universal screening of eligible people aged 35 and older would yield a ratio of 1 out of just 15 to spot a positive test, the authors of that study reported.

In addition, a large cohort study in more than 77,000 people with prediabetes strongly links the risk of developing diabetes with increases in A1c level and with increasing BMI.
 

ADA recommendations differ

The new recommendations differ from American Diabetes Association guidelines, which call for diabetes screening at all ages for people who are overweight or obese and who have one or more risk factors, such as physical inactivity or a first-degree relative with diabetes. If results are normal, repeat screening at least every 3 years is recommended.

The ADA further recommends universal screening for all adults 45 years and older, regardless of their risk factors.

For the screening of adults over 45, the ADA recommends using a fasting plasma glucose level, 2-hour plasma glucose level during a 75-g oral glucose tolerance test, or A1c level, regardless of risk factors.

The American Association of Clinical Endocrinology also recommends universal screening for prediabetes and diabetes for all adults 45 years or older, regardless of risk factors, and also advises screening those who have risk factors for diabetes regardless of age.
 

Screening of little benefit without behavior change support

In an interview, Dr. Grant added that broad efforts are essential as those at the practice level have clearly not succeeded.

“The medical model of individual counseling and referral has not really been effective, and so we really need to think in terms of large-scale public health action,” said Dr. Grant, of the division of research, Kaiser Permanente Northern California, Oakland.

His editorial details the sweeping, multifactorial efforts that are needed.

“To turn this recommendation into action – that is, to translate screening activities into improved clinical outcomes – change is needed at the patient-clinician level (recognizing and encouraging eligible individuals to be screened), health care system level (reducing screening barriers and ensuring access to robust lifestyle programs), and societal level (applying effective public health interventions to reduce obesity and increase exercise),” they write.

A top priority has to be a focus on individuals of diverse backgrounds and issues such as access to healthy programs in minority communities, Dr. Grant noted.

“Newly diagnosed adults are more likely to be African-American and Latinx,” he said.

“We really need to invest in healthier communities for low-income, non-White communities to reverse the persistent health care disparities in these communities.”

While the challenges may appear daunting, history shows they are not necessarily insurmountable – as evidenced in the campaign to discourage tobacco smoking.

“National smoking cessation efforts are one example of a mostly successful public health campaign that has made a difference in health behaviors,” Grant noted.

The recommendation is also posted on the USPSTF web site .

Dr. Grant reports receiving grants from the National Institutes of Health and the Patient-Centered Outcomes Research Institute.

The United States Preventive Services Task Force has updated its recommendation on the age of screening for prediabetes and type 2 diabetes in the primary care setting – lowering the age from 40 to 35 years for asymptomatic patients who are overweight or obese and encouraging greater interventions when patients do show a risk.

KatarzynaBialasiewicz/Thinkstock

“The USPSTF concludes with moderate certainty that screening for prediabetes and type 2 diabetes and offering or referring patients with prediabetes to effective preventive interventions has a moderate net benefit,” the task force concludes in its recommendation, published Aug. 24 in JAMA.

“Clinicians should offer or refer patients with prediabetes to effective preventive interventions,” they write.

Experts commenting on the issue strongly emphasize that it’s not just the screening, but the subsequent intervention that is needed to make a difference.

“If young adults newly identified with abnormal glucose metabolism do not receive the needed intensive behavioral change support, screening may provide no benefit,” write Richard W. Grant, MD, MPH, and colleagues in an editorial published with the recommendation.

“Given the role of our obesogenic and physically inactive society in the shift toward earlier onset of diabetes, efforts to increase screening and recognition of abnormal glucose metabolism must be coupled with robust public health measures to address the underlying contributors.”
 

BMI cutoff lower for at-risk ethnic populations

The recommendation, which updates the task force’s 2015 guideline, carries a “B” classification, meaning the USPSTF has high certainty that the net benefit is moderate. It now specifies screening from age 35to 70 for persons classified as overweight (body mass index at least 25) or obese (BMI at least 30) and recommends referral to preventive interventions when patients are found to have prediabetes.

In addition to recommendations of lifestyle changes, such as diet and physical activity, the task force also endorses the diabetes drug metformin as a beneficial intervention in the prevention or delay of diabetes, while noting fewer overall health benefits from metformin than from the lifestyle changes.

A lower BMI cutoff of at least 23 is recommended for diabetes screening of Asian Americans, and, importantly, screening for prediabetes and diabetes should be considered at an even earlier age if the patient is from a population with a disproportionately high prevalence of diabetes, including American Indian/Alaska Native, Black, Hawaiian/Pacific Islander, Hispanic/Latino, the task force recommends.

Screening tests should include fasting plasma glucose, hemoglobin A1c, or an oral glucose tolerance test. Although screening every 3 years “may be a reasonable approach for adults with normal blood glucose levels,” the task force adds that “the optimal screening interval for adults with an initial normal glucose test result is uncertain.”
 

Data review: Few with prediabetes know they have it

The need for the update was prompted by troubling data showing increasing diabetes rates despite early signs that can and should be identified and acted upon in the primary care setting to prevent disease progression.

Data from the Centers for Disease Control and Prevention, for instance, show that while 13% of all U.S. adults 18 years or older have diabetes and 35% meet criteria for prediabetes, as many as 21% of those with diabetes were not aware of or did not report having the disease. Furthermore, only a small fraction – 15% of those with prediabetes – said they had been told by a health professional that they had this condition, the task force notes.

The task force’s final recommendation was based on a systematic review of evidence regarding the screening of asymptomatic, nonpregnant adults and the harms and benefits of interventions, such as physical activity, behavioral counseling, or pharmacotherapy.

Among key evidence supporting the lower age was a 2014 study showing that the number of people necessary to obtain one positive test for diabetes with screening sharply drops from 80 among those aged 30-34 years to just 31 among those aged 36-39.

Opportunistic universal screening of eligible people aged 35 and older would yield a ratio of 1 out of just 15 to spot a positive test, the authors of that study reported.

In addition, a large cohort study in more than 77,000 people with prediabetes strongly links the risk of developing diabetes with increases in A1c level and with increasing BMI.
 

ADA recommendations differ

The new recommendations differ from American Diabetes Association guidelines, which call for diabetes screening at all ages for people who are overweight or obese and who have one or more risk factors, such as physical inactivity or a first-degree relative with diabetes. If results are normal, repeat screening at least every 3 years is recommended.

The ADA further recommends universal screening for all adults 45 years and older, regardless of their risk factors.

For the screening of adults over 45, the ADA recommends using a fasting plasma glucose level, 2-hour plasma glucose level during a 75-g oral glucose tolerance test, or A1c level, regardless of risk factors.

The American Association of Clinical Endocrinology also recommends universal screening for prediabetes and diabetes for all adults 45 years or older, regardless of risk factors, and also advises screening those who have risk factors for diabetes regardless of age.
 

Screening of little benefit without behavior change support

In an interview, Dr. Grant added that broad efforts are essential as those at the practice level have clearly not succeeded.

“The medical model of individual counseling and referral has not really been effective, and so we really need to think in terms of large-scale public health action,” said Dr. Grant, of the division of research, Kaiser Permanente Northern California, Oakland.

His editorial details the sweeping, multifactorial efforts that are needed.

“To turn this recommendation into action – that is, to translate screening activities into improved clinical outcomes – change is needed at the patient-clinician level (recognizing and encouraging eligible individuals to be screened), health care system level (reducing screening barriers and ensuring access to robust lifestyle programs), and societal level (applying effective public health interventions to reduce obesity and increase exercise),” they write.

A top priority has to be a focus on individuals of diverse backgrounds and issues such as access to healthy programs in minority communities, Dr. Grant noted.

“Newly diagnosed adults are more likely to be African-American and Latinx,” he said.

“We really need to invest in healthier communities for low-income, non-White communities to reverse the persistent health care disparities in these communities.”

While the challenges may appear daunting, history shows they are not necessarily insurmountable – as evidenced in the campaign to discourage tobacco smoking.

“National smoking cessation efforts are one example of a mostly successful public health campaign that has made a difference in health behaviors,” Grant noted.

The recommendation is also posted on the USPSTF web site .

Dr. Grant reports receiving grants from the National Institutes of Health and the Patient-Centered Outcomes Research Institute.

Using a procedureless intragastric balloon (PIGB) as a first-line treatment for obesity is cost effective as either a standalone intervention or a bridge to bariatric surgery, according to a new simulation model study published in PLOS One.

PIGB boasts a noninvasive delivery mechanism in the form of a swallowable capsule. Upon reaching the stomach, the capsule is filled with fluid via a catheter. The clinician uses x-ray or fluoroscopy to confirm correct positioning of the balloon. After 4 months, the balloon’s release valve opens to drain the fluid, and the balloon is excreted naturally. If presented with a major complication, clinicians can typically remove PIGB endoscopically. This not only translates into much lower costs than bariatric surgery but also fewer adverse events.

The available evidence surrounding PIGB’s relative efficacy is less clear. Prior studies have shown that PIGB produces an average weight loss of 14.2% after a single, 4-month treatment episode, compared with 32% after bariatric surgery. When compared against other intragastric balloon devices, however, PIGB has been shown to lead to comparable or superior levels of weight loss. There is also limited evidence about PIGB’s long-term efficacy, but some data suggest that weight lost is generally regained after removal of the balloon.

To date, though, there had been no analysis of whether PIBG’s proposed advantages would make it more cost effective when measured against the superior outcomes of commonly performed bariatric surgeries.
 

Assessing the cost of PIGB

Researchers compared the cost-effectiveness of six regimens: PIGB; standalone gastric bypass or sleeve gastrectomy; PIGB as a bridge to gastric bypass or sleeve gastrectomy; and no treatment. The specific PIGB device the investigators assessed was the Elipse balloon (Allurion Technologies), which is approved in Europe, Asia, and Latin America, and is in the premarket approval process in the United States.

They then applied an individual patient-level Markov microsimulation model to compare these separate regimens in terms of costs and quality-adjusted life years (QALYs). The simulation incorporated data from 10,000 adults aged 18-64 with body mass index (BMI) ≥ 35, of which 44% had a BMI ≥ 40. The model assumed patients initially underwent treatment with PIGB, gastric bypass, or sleeve gastrectomy. Based on the predicted weight loss resulting from that intervention, the model then estimated how PIGB-only, gastric bypass–only, and sleeve gastrectomy–only patients transitioned to a new health state, ranging from no obesity to death. It also incorporated a hybrid strategy in which patients underwent bariatric surgery if their BMI was still ≥ 35. The researchers modeled complications in all groups as chance events, with a probability of occurrence based on BMI state.

The model determined that the most cost-effective approach was using PIGB as a bridge to sleeve gastrectomy, which had an incremental cost-effectiveness ratio (ICER) of $3,781 per QALY. PIGB alone was not cost effective versus bariatric surgery, but it did outperform no treatment (ICER, $21,711 per QALY).

The study investigators noted that there was a counterintuitive aspect to finding that PIGB was most cost effective when used as a bridge to surgery.

“Contrary to expectations that an add-on treatment to already expensive bariatric surgery would further increase health care costs, our results show that using PIGB as an add-on treatment reduces total costs and improves health outcomes, compared with bariatric surgery alone,” they wrote. “Consequently, as decision-makers look for ways to curb rising health care costs, it will be worthwhile to consider incorporating PIGB prior to bariatric surgery within the clinical care pathway.”

They also noted that initial PIGB may help patients achieve a lower BMI following surgery.
 

An appealing option

“This technique is very appealing to a lot of patients because you don’t need sedation, you can do it fairly quickly, and the risks and complications of endoscopy or surgery aren’t there with the procedureless balloon, at least on implantation,” said Reem Sharaiha, MD, associate professor of medicine and director of Bariatric & Metabolic Endoscopy at Weill Cornell Medicine, when asked to comment on the study’s results. “I believe that you need to offer a lot of options to tackle obesity as an epidemic and to give patients multiple treatment options, because it’s not going to be a one and done. It’s going to be multiple procedures in their lifetime.”

Dr. Sharaiha added that PIGB’s noninvasive qualities may make it a viable option for addressing a notable gap in obesity treatment; only about 2% of individuals who would qualify for surgery actually do so each year.

“A lot of people are reluctant to undergo it because of the fear of complications or the fear of invasiveness. They do not want to be off work for many weeks,” she said. “Many people come to see me and say, ‘I don’t want to tell anyone that I’ve had it done.’ Or, ‘I don’t want any scars.’ So, a lot of these [factors] come into play as well.”

Dr. Sharaiha is a consultant for Boston Scientific and has participated in trials conducted to seek Food and Drug Administration approval for the Elipse device.

Using a procedureless intragastric balloon (PIGB) as a first-line treatment for obesity is cost effective as either a standalone intervention or a bridge to bariatric surgery, according to a new simulation model study published in PLOS One.

PIGB boasts a noninvasive delivery mechanism in the form of a swallowable capsule. Upon reaching the stomach, the capsule is filled with fluid via a catheter. The clinician uses x-ray or fluoroscopy to confirm correct positioning of the balloon. After 4 months, the balloon’s release valve opens to drain the fluid, and the balloon is excreted naturally. If presented with a major complication, clinicians can typically remove PIGB endoscopically. This not only translates into much lower costs than bariatric surgery but also fewer adverse events.

The available evidence surrounding PIGB’s relative efficacy is less clear. Prior studies have shown that PIGB produces an average weight loss of 14.2% after a single, 4-month treatment episode, compared with 32% after bariatric surgery. When compared against other intragastric balloon devices, however, PIGB has been shown to lead to comparable or superior levels of weight loss. There is also limited evidence about PIGB’s long-term efficacy, but some data suggest that weight lost is generally regained after removal of the balloon.

To date, though, there had been no analysis of whether PIBG’s proposed advantages would make it more cost effective when measured against the superior outcomes of commonly performed bariatric surgeries.
 

Assessing the cost of PIGB

Researchers compared the cost-effectiveness of six regimens: PIGB; standalone gastric bypass or sleeve gastrectomy; PIGB as a bridge to gastric bypass or sleeve gastrectomy; and no treatment. The specific PIGB device the investigators assessed was the Elipse balloon (Allurion Technologies), which is approved in Europe, Asia, and Latin America, and is in the premarket approval process in the United States.

They then applied an individual patient-level Markov microsimulation model to compare these separate regimens in terms of costs and quality-adjusted life years (QALYs). The simulation incorporated data from 10,000 adults aged 18-64 with body mass index (BMI) ≥ 35, of which 44% had a BMI ≥ 40. The model assumed patients initially underwent treatment with PIGB, gastric bypass, or sleeve gastrectomy. Based on the predicted weight loss resulting from that intervention, the model then estimated how PIGB-only, gastric bypass–only, and sleeve gastrectomy–only patients transitioned to a new health state, ranging from no obesity to death. It also incorporated a hybrid strategy in which patients underwent bariatric surgery if their BMI was still ≥ 35. The researchers modeled complications in all groups as chance events, with a probability of occurrence based on BMI state.

The model determined that the most cost-effective approach was using PIGB as a bridge to sleeve gastrectomy, which had an incremental cost-effectiveness ratio (ICER) of $3,781 per QALY. PIGB alone was not cost effective versus bariatric surgery, but it did outperform no treatment (ICER, $21,711 per QALY).

The study investigators noted that there was a counterintuitive aspect to finding that PIGB was most cost effective when used as a bridge to surgery.

“Contrary to expectations that an add-on treatment to already expensive bariatric surgery would further increase health care costs, our results show that using PIGB as an add-on treatment reduces total costs and improves health outcomes, compared with bariatric surgery alone,” they wrote. “Consequently, as decision-makers look for ways to curb rising health care costs, it will be worthwhile to consider incorporating PIGB prior to bariatric surgery within the clinical care pathway.”

They also noted that initial PIGB may help patients achieve a lower BMI following surgery.
 

An appealing option

“This technique is very appealing to a lot of patients because you don’t need sedation, you can do it fairly quickly, and the risks and complications of endoscopy or surgery aren’t there with the procedureless balloon, at least on implantation,” said Reem Sharaiha, MD, associate professor of medicine and director of Bariatric & Metabolic Endoscopy at Weill Cornell Medicine, when asked to comment on the study’s results. “I believe that you need to offer a lot of options to tackle obesity as an epidemic and to give patients multiple treatment options, because it’s not going to be a one and done. It’s going to be multiple procedures in their lifetime.”

Dr. Sharaiha added that PIGB’s noninvasive qualities may make it a viable option for addressing a notable gap in obesity treatment; only about 2% of individuals who would qualify for surgery actually do so each year.

“A lot of people are reluctant to undergo it because of the fear of complications or the fear of invasiveness. They do not want to be off work for many weeks,” she said. “Many people come to see me and say, ‘I don’t want to tell anyone that I’ve had it done.’ Or, ‘I don’t want any scars.’ So, a lot of these [factors] come into play as well.”

Dr. Sharaiha is a consultant for Boston Scientific and has participated in trials conducted to seek Food and Drug Administration approval for the Elipse device.

Using a procedureless intragastric balloon (PIGB) as a first-line treatment for obesity is cost effective as either a standalone intervention or a bridge to bariatric surgery, according to a new simulation model study published in PLOS One.

PIGB boasts a noninvasive delivery mechanism in the form of a swallowable capsule. Upon reaching the stomach, the capsule is filled with fluid via a catheter. The clinician uses x-ray or fluoroscopy to confirm correct positioning of the balloon. After 4 months, the balloon’s release valve opens to drain the fluid, and the balloon is excreted naturally. If presented with a major complication, clinicians can typically remove PIGB endoscopically. This not only translates into much lower costs than bariatric surgery but also fewer adverse events.

The available evidence surrounding PIGB’s relative efficacy is less clear. Prior studies have shown that PIGB produces an average weight loss of 14.2% after a single, 4-month treatment episode, compared with 32% after bariatric surgery. When compared against other intragastric balloon devices, however, PIGB has been shown to lead to comparable or superior levels of weight loss. There is also limited evidence about PIGB’s long-term efficacy, but some data suggest that weight lost is generally regained after removal of the balloon.

To date, though, there had been no analysis of whether PIBG’s proposed advantages would make it more cost effective when measured against the superior outcomes of commonly performed bariatric surgeries.
 

Assessing the cost of PIGB

Researchers compared the cost-effectiveness of six regimens: PIGB; standalone gastric bypass or sleeve gastrectomy; PIGB as a bridge to gastric bypass or sleeve gastrectomy; and no treatment. The specific PIGB device the investigators assessed was the Elipse balloon (Allurion Technologies), which is approved in Europe, Asia, and Latin America, and is in the premarket approval process in the United States.

They then applied an individual patient-level Markov microsimulation model to compare these separate regimens in terms of costs and quality-adjusted life years (QALYs). The simulation incorporated data from 10,000 adults aged 18-64 with body mass index (BMI) ≥ 35, of which 44% had a BMI ≥ 40. The model assumed patients initially underwent treatment with PIGB, gastric bypass, or sleeve gastrectomy. Based on the predicted weight loss resulting from that intervention, the model then estimated how PIGB-only, gastric bypass–only, and sleeve gastrectomy–only patients transitioned to a new health state, ranging from no obesity to death. It also incorporated a hybrid strategy in which patients underwent bariatric surgery if their BMI was still ≥ 35. The researchers modeled complications in all groups as chance events, with a probability of occurrence based on BMI state.

The model determined that the most cost-effective approach was using PIGB as a bridge to sleeve gastrectomy, which had an incremental cost-effectiveness ratio (ICER) of $3,781 per QALY. PIGB alone was not cost effective versus bariatric surgery, but it did outperform no treatment (ICER, $21,711 per QALY).

The study investigators noted that there was a counterintuitive aspect to finding that PIGB was most cost effective when used as a bridge to surgery.

“Contrary to expectations that an add-on treatment to already expensive bariatric surgery would further increase health care costs, our results show that using PIGB as an add-on treatment reduces total costs and improves health outcomes, compared with bariatric surgery alone,” they wrote. “Consequently, as decision-makers look for ways to curb rising health care costs, it will be worthwhile to consider incorporating PIGB prior to bariatric surgery within the clinical care pathway.”

They also noted that initial PIGB may help patients achieve a lower BMI following surgery.
 

An appealing option

“This technique is very appealing to a lot of patients because you don’t need sedation, you can do it fairly quickly, and the risks and complications of endoscopy or surgery aren’t there with the procedureless balloon, at least on implantation,” said Reem Sharaiha, MD, associate professor of medicine and director of Bariatric & Metabolic Endoscopy at Weill Cornell Medicine, when asked to comment on the study’s results. “I believe that you need to offer a lot of options to tackle obesity as an epidemic and to give patients multiple treatment options, because it’s not going to be a one and done. It’s going to be multiple procedures in their lifetime.”

Dr. Sharaiha added that PIGB’s noninvasive qualities may make it a viable option for addressing a notable gap in obesity treatment; only about 2% of individuals who would qualify for surgery actually do so each year.

“A lot of people are reluctant to undergo it because of the fear of complications or the fear of invasiveness. They do not want to be off work for many weeks,” she said. “Many people come to see me and say, ‘I don’t want to tell anyone that I’ve had it done.’ Or, ‘I don’t want any scars.’ So, a lot of these [factors] come into play as well.”

Dr. Sharaiha is a consultant for Boston Scientific and has participated in trials conducted to seek Food and Drug Administration approval for the Elipse device.

In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.

One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.

Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.

One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.

Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The long list of side effects that follow ads for newer expensive drugs to treat type 2 diabetes sometimes include an unusual warning: They might cause weight loss. That side effect is one that many people – especially those with type 2 diabetes, which is associated with obesity – may desperately want.

So it’s no surprise that some of the same drugs are being reformulated and renamed by manufacturers as a new obesity treatment. No longer limited to the crowded field of treatments for type 2 diabetes, which affects about 10% of Americans, they join the far smaller number of drugs for obesity, which affects 42% of Americans and is ready to be mined for profit.

One that recently hit the market – winning Food and Drug Administration approval in June – is Novo Nordisk’s Wegovy (semaglutide), a higher-dose version of the company’s injectable diabetes drug, Ozempic.

Ozempic’s peppy ads suggest that people who use it might lose weight, but also include a disclaimer: that it “is not a weight-loss drug.” Now – with a new name – it is. And clinical trials showed using it leads to significant weight loss for many patients.

“People who go on this medication lose more weight than with any drug we’ve seen, ever,” said Fatima Cody Stanford, MD, MPH, an obesity medicine specialist at Massachusetts General Hospital and Harvard Medical School, both in Boston, who was not involved with any of the clinical trials.

But that leaves employers and insurers in the uncomfortable position of deciding if it’s worth it.

Wegovy’s monthly wholesale price tag – set at $1,349 – is about 58% more than Ozempic’s, although, the company pointed out, the drug’s injector pens contain more than twice as much of the active ingredient. Studies so far show that patients may need to take it indefinitely to maintain weight loss, translating to a tab that could top $323,000 over 20 years at the current price. Weight-loss treatments are not universally covered by insurance policies.

The arrival of this new class of weight-loss drugs – one from Lilly may soon follow – has created a thicket of issues for those who will pay for them. The decision is complicated by many unknowables concerning their long-term use and whether competition might eventually lower the price.

“The metric we try to use is value,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large, self-insured employers. “If we pay for this drug, how much is this going to cost and how much value will it provide to the beneficiaries?”

Weight-loss treatments have had a lackluster past in this regard, with only modest results. Many employers and insurers likely remember Fen-Phen, a combination of fenfluramine and dexfenfluramine that was pulled from the market in the late 1990s for causing heart valve problems.

New drugs like Wegovy, more effective but also pricier than previous weight-loss treatments, will add more fuel to that debate.

Past treatments were shown to prompt weight loss in the range of 5%-10% of body weight. But many had relatively serious or unpleasant side effects.

Wegovy, however, helped patients lose an average of 15% of their body weight over 68 weeks in the main clinical trial that led to its approval. A comparison group that got a placebo injection lost an average of 2.5% over the same period. On the high end, nearly a third of patients in the treatment group lost 20% or more. Both groups had counseling on diet and exercise.

Side effects, generally considered mild, included nausea, diarrhea, vomiting, and constipation. A few patients developed pancreatitis, a serious inflammation of the pancreas. Like the diabetes medication, the drug carries a warning about a potential risk of a type of thyroid cancer.

Weight loss in those taking Wegovy puts it close to the 20%-25% losses seen with bariatric surgery, said Stanford, and well above the 3%-4% seen with diet and other lifestyle changes alone.

Participants also saw reductions in their waistlines and improvements in their blood pressure and blood sugar levels, which may mean they won’t develop diabetes, said Sean Wharton, MD, an internal medicine specialist and adjunct professor at York University in Toronto who was among the coauthors of the report outlining the results of the first clinical trial on Wegovy.

Since weight loss is known to reduce the risk of heart attack, high blood pressure and diabetes, might the new drug type be worth it?

Covering such treatment would be a sea change for Medicare, which specifically bars coverage for obesity medications or drugs for “anorexia, weight loss, or weight gain,” although it does pay for bariatric surgery. Pharmaceutical companies, patient advocates, and some medical professionals are backing proposed federal legislation to allow coverage. But the legislation, the Treat and Reduce Obesity Act, has not made progress despite being reintroduced every year since 2012, and sponsors are now asking federal officials instead to rewrite existing rules.

Private insurers will have to consider a cost-benefit analysis of adding Wegovy to their list of covered treatments, either broadly or with limits. Obesity was first recognized as a disease by the American Medical Association, easing the path for insurance coverage, in 2013.

“Employers are going to have a bit of a challenge” deciding whether to add the benefit to insurance offerings, said Steve Pearson, founder and president of the Institute for Clinical and Economic Review, which provides cost-benefit analyses of medical treatments but has not yet looked at Wegovy.

The trade-offs are embodied in patients like Phylander Pannell, a 49-year-old Largo, Md., woman who said she lost 65 pounds in a clinical trial of Wegovy. That study gave the drug to all participants for the first 20 weeks, then randomly assigned patients to get either the drug or a placebo for the next 48 weeks to determine what happens when the medication is stopped. Only after the trial ended did she find out she was in the treatment group the entire time.

Her weight fell slowly at first, then ramped up, eventually bringing her 190-pound frame down to about 125. Pains in her joints eased; she felt better all around.

“I definitely feel the drug was it for me,” said Ms. Pannell, who also followed the trial’s guidance on diet and exercise.

The study found that both groups lost weight in the initial 20 weeks, but those who continued to get the drug lost an additional average of 7.9% of their body weight. Those who got a placebo gained back nearly 7%.

After the trial ended, and the COVID-19 pandemic hit, Ms. Pannell regained some weight and is now at 155. She is eager to get back on the medication and hopes her job-based insurance will cover it.

Many employers do cover obesity drugs. For example, about 40% of private employer plans include Novo Nordisk’s once-daily injection called Saxenda on their health plans, said Michael Bachner, Novo Nordisk’s director of media relations.

He said the $1,349-a-month wholesale acquisition price of Wegovy was determined by making it equivalent to that of Saxenda, which is less effective.

Still, that is more than the $851 monthly wholesale price of Ozempic. But, he pointed out, the recommended dosage of Wegovy is more than twice that of Ozempic. Four milligrams come in the Ozempic injector pens for the month, while Wegovy has 9.6.

“There’s more drug in the pen,” Mr. Bachner said. “That drives the price up.”

He added: “This is not a 20-year-old drug that we now have a new indication for and are pricing it higher. It’s a whole different clinical program,” which required new trials.

Now scientists, employers, physicians, and patients will have to decide whether the new drugs are worth it.

Earlier estimates – some commissioned by Novo Nordisk – of the potential cost of adding an obesity drug benefit to Medicare showed an overall reduction in spending when better health from the resulting weight loss was factored in.

Still, those earlier estimates considered much less expensive drugs, including a range of generic and branded drugs costing as little as $7 a month to more than $300, a small fraction of Wegovy’s cost.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

When it comes to dieting and heart health in patients who are also exercising, less is more, suggests a new study.

The authors of the paper, published in Circulation, found a link between greater vascular benefits and exercise with modest – rather than intense – calorie restriction (CR) in elderly individuals with obesity.

“The finding that higher-intensity calorie restriction may not be necessary or advised has important implications for weight loss recommendations,” noted Tina E. Brinkley, Ph.D., lead author of the study and associate professor of gerontology and geriatric medicine at the Sticht Center for Healthy Aging and Alzheimer’s Prevention at Wake Forest University in Winston-Salem, N.C.

It’s “not entirely clear” why greater calorie restriction did not translate to greater vascular benefit, but it “could be related in part to potentially adverse effects of severe CR on vascular function,” she noted. “These findings have important implications for reducing cardiovascular risk with nonpharmacological interventions in high-risk populations.”

Methods and findings

The study included 160 men and women aged 65-79 years, with a body mass index (BMI) of 30 to 45 kg/m². The subjects were randomized to one of three groups for 20 weeks of aerobic exercise only, aerobic exercise plus moderate CR, or aerobic exercise plus more intensive CR. Their exercise regimen involved 30 minutes of supervised treadmill walking for 4 days per week at 65%-70% of heart rate reserve.

Subjects in the moderate CR group decreased caloric intake by 250 kcals a day, while the intense calorie reduction group cut 600 kcals per day. Their meals contained less than 30% of calories from fat and at least 0.8 g of protein per kg of ideal body weight. They were also provided with supplemental calcium (1,200 mg/day) and vitamin D (800 IU/day).

Cardiovascular magnetic resonance imaging was used to assess various aspects of aortic structure and function, including aortic arch pulse wave velocity, aortic distensibility and dimensions, and periaortic fat.

Weight loss was greater among subjects with CR plus exercise, compared with that of patients in the exercise-only group. The degree of weight loss was not significantly different between those with moderate versus intense CR ( 8.02 kg vs. 8.98 kg).

Among the exercise-only group, researchers observed no changes in aortic stiffness. However, adding moderate CR significantly improved this measure, while intense CR did not.

Specifically, subjects in the moderate-CR group had a “robust” 21% increase in distensibility in the descending aorta (DA), and an 8% decrease in aortic arch pulse wave velocity, whereas there were no significant vascular changes in the intense-CR group.

Bests results seen in exercise plus modest CR group

“Collectively, these data suggest that combining exercise with modest CR (as opposed to more intensive CR or no CR) provides the greatest benefit for proximal aortic stiffness, while also optimizing weight loss and improvements in body composition and body fat distribution,” noted the authors in their paper.

“Our data support the growing number of studies indicating that intentional weight loss can be safe for older adults with obesity and extend our previous findings, suggesting that obesity may blunt the beneficial effects of exercise for not only cardiorespiratory fitness, but likely vascular health as well.”

William E. Kraus, MD, professor in the Department of Medicine, Division of Cardiology at Duke University Medical Center, in Durham, NC, described the study as important and interesting for several reasons.

“First, it demonstrates one can change aortic vascular function with a combined diet and exercise program, even in older, obese Americans. This implies it is never too late to make meaningful lifestyle changes that will benefit cardiovascular health,” he said. “Second, it is among an increasing number of studies demonstrating that more is not always better than less in exercise and diet lifestyle changes - and in fact the converse is true.” 

“This gives hope that more people can benefit from modest lifestyle changes - in this case following guidelines for physical activity and only a modest reduction of 250 kilocalories per day resulted in benefit,” Dr. Kraus added.

The authors of the paper and Dr. Kraus disclosed no conflicts of interest.

Small increases in daily physical activity are associated with a boost in 1-year survival in patients with heart failure and coronary disease who received an implantable cardioverter defibrillator (ICD), new research suggests.

“Our study looked at how much exercise was necessary for a better outcome in patients with prior ICD implantation and, for every 10 minutes of exercise, we saw a 1% reduction in the likelihood of death or hospitalization, which is a pretty profound impact on outcome for just a small amount of additional physical activity per day,” lead author Brett Atwater, MD, told this news organization.

“These improvements were achieved outside of a formal cardiac rehabilitation program, suggesting that the benefits of increased physical activity obtained in cardiac rehabilitation programs may also be achievable at home,” he said.

Cardiac rehabilitation (CR) programs have been shown to improve short- and long-term outcomes in patients with heart failure (HF) but continue to be underutilized, especially by women, the elderly, and minorities. Home-based CR could help overcome this limitation but the science behind it is relatively new, noted Dr. Atwater, director of electrophysiology and electrophysiology research, Inova Heart and Vascular Institute, Fairfax, Va.

As reported in Circulation Cardiovascular Quality and Outcomes, the study involved 41,731 Medicare beneficiaries (mean age, 73.5 years) who received an ICD from 2014 to 2016.

ICD heart rate and activity sensor measurements were used to establish a personalized physical activity (PA) threshold for each patient in the first 3 weeks after ICD implantation. Thereafter, the ICD logged PA when the personalized PA threshold was exceeded. The mean baseline PA level was 128.9 minutes/day.

At 3 years’ follow-up, one-quarter of the patients had died and half had been hospitalized for HF. Of the total population, only 3.2% participated in CR.

Compared with nonparticipants, CR participants were more likely to be White (91.0% versus 87.3%), male (75.5% versus 72.2%), and to have diabetes (48.8% versus 44.1%), ischemic heart disease (91.4% versus 82.1%), or congestive heart failure (90.4% versus 83.4%).

CR participants attended a median of 24 sessions, during which time daily PA increased by a mean of 9.7 minutes per day. During the same time, PA decreased by a mean of 1.0 minute per day in non-CR participants (P < .001).

PA levels remained “relatively constant” for the first 36 months of follow-up among CR participants before showing a steep decline, whereas levels gradually declined throughout follow-up among nonparticipants, with a median annual change of –4.5 min/day.

In adjusted analysis, every 10 minutes of increased daily PA was associated with a 1.1% reduced risk for death (hazard ratio, 0.989; 95% confidence interval, 0.979-0.996) and a 1% reduced risk for HF hospitalization (HR, 0.99; 95% CI, 0.986-0.995) at 1-year follow-up (P < .001).

After propensity score was used to match CR participants with nonparticipants by demographic characteristics, comorbidities, and baseline PA level, CR participants had a significantly lower risk for death at 1 year (HR, 0.76; 95% CI, 0.69-0.85). This difference in risk remained at 2- and 3-year follow-ups.

However, when the researchers further adjusted for change in PA during CR or the same time period after device implantation, no differences in mortality were found between CR participants and nonparticipants at 1 year (HR, 1.00; 95% CI, 0.82-1.21) or at 2 or 3 years.

The risk for HF hospitalization did not differ between the two groups in either propensity score model.

Unlike wearable devices, implanted devices “don’t give that type of feedback to patients regarding PA levels – only to providers – and it will be interesting to discover whether providing feedback to patients can motivate them to do more physical activity,” Dr. Atwater commented.

The team is currently enrolling patients in a follow-up trial, in which patients will be given feedback from their ICD “to move these data from an interesting observation to something that can drive outcomes,” he said.

Commenting for this news organization, Melissa Tracy, MD, Rush University Medical Center, Chicago, said the study reiterates the “profound” underutilization of CR.

“Only about 3% of patients who should have qualified for cardiac rehabilitation actually attended, which is startling considering that it has class 1A level of evidence supporting its use,” she said.

Dr. Tracy, who is also a member of the American College of Cardiology’s Prevention of Cardiovascular Disease Section Leadership Council, described the study as “another notch in the belt of positive outcomes supporting the need for cardiac rehabilitation” and emphasizing the importance of a home-based alternative.

“One of the reasons women, minorities, and older patients don’t go to cardiac rehabilitation is they have to get there, rely on someone to drive them, or they have other responsibilities – especially women, who are often primary caretakers of others,” she said. “For women and men, the pressure to get back to work and support their families means they don’t have the luxury to go to cardiac rehabilitation.”

Dr. Tracy noted that home-based CR is covered by CMS until the end of 2021. “An important take-home is for providers and patients to understand that they do have a home-based option,” she stated.

Limitations of the study are that only 24% of patients were women, only 6% were Black, and the results might not be generalizable to patients younger than 65 years, note Dr. Atwater and colleagues. Also, previous implantation might have protected the cohort from experiencing arrhythmic death, and it remains unclear if similar results would be obtained in patients without a previous ICD.

This research was funded through the unrestricted Abbott Medical-Duke Health Strategic Alliance Research Grant. Dr. Atwater receives significant research support from Boston Scientific and Abbott Medical, and modest honoraria from Abbott Medical, Medtronic, and Biotronik. Coauthor disclosures are listed in the paper. Dr. Tracy has created cardiac prevention programs with Virtual Health Partners (VHP) and owns the intellectual property and consults with VHP but receives no monetary compensation.
 

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

Small increases in daily physical activity are associated with a boost in 1-year survival in patients with heart failure and coronary disease who received an implantable cardioverter defibrillator (ICD), new research suggests.

“Our study looked at how much exercise was necessary for a better outcome in patients with prior ICD implantation and, for every 10 minutes of exercise, we saw a 1% reduction in the likelihood of death or hospitalization, which is a pretty profound impact on outcome for just a small amount of additional physical activity per day,” lead author Brett Atwater, MD, told this news organization.

“These improvements were achieved outside of a formal cardiac rehabilitation program, suggesting that the benefits of increased physical activity obtained in cardiac rehabilitation programs may also be achievable at home,” he said.

Cardiac rehabilitation (CR) programs have been shown to improve short- and long-term outcomes in patients with heart failure (HF) but continue to be underutilized, especially by women, the elderly, and minorities. Home-based CR could help overcome this limitation but the science behind it is relatively new, noted Dr. Atwater, director of electrophysiology and electrophysiology research, Inova Heart and Vascular Institute, Fairfax, Va.

As reported in Circulation Cardiovascular Quality and Outcomes, the study involved 41,731 Medicare beneficiaries (mean age, 73.5 years) who received an ICD from 2014 to 2016.

ICD heart rate and activity sensor measurements were used to establish a personalized physical activity (PA) threshold for each patient in the first 3 weeks after ICD implantation. Thereafter, the ICD logged PA when the personalized PA threshold was exceeded. The mean baseline PA level was 128.9 minutes/day.

At 3 years’ follow-up, one-quarter of the patients had died and half had been hospitalized for HF. Of the total population, only 3.2% participated in CR.

Compared with nonparticipants, CR participants were more likely to be White (91.0% versus 87.3%), male (75.5% versus 72.2%), and to have diabetes (48.8% versus 44.1%), ischemic heart disease (91.4% versus 82.1%), or congestive heart failure (90.4% versus 83.4%).

CR participants attended a median of 24 sessions, during which time daily PA increased by a mean of 9.7 minutes per day. During the same time, PA decreased by a mean of 1.0 minute per day in non-CR participants (P < .001).

PA levels remained “relatively constant” for the first 36 months of follow-up among CR participants before showing a steep decline, whereas levels gradually declined throughout follow-up among nonparticipants, with a median annual change of –4.5 min/day.

In adjusted analysis, every 10 minutes of increased daily PA was associated with a 1.1% reduced risk for death (hazard ratio, 0.989; 95% confidence interval, 0.979-0.996) and a 1% reduced risk for HF hospitalization (HR, 0.99; 95% CI, 0.986-0.995) at 1-year follow-up (P < .001).

After propensity score was used to match CR participants with nonparticipants by demographic characteristics, comorbidities, and baseline PA level, CR participants had a significantly lower risk for death at 1 year (HR, 0.76; 95% CI, 0.69-0.85). This difference in risk remained at 2- and 3-year follow-ups.

However, when the researchers further adjusted for change in PA during CR or the same time period after device implantation, no differences in mortality were found between CR participants and nonparticipants at 1 year (HR, 1.00; 95% CI, 0.82-1.21) or at 2 or 3 years.

The risk for HF hospitalization did not differ between the two groups in either propensity score model.

Unlike wearable devices, implanted devices “don’t give that type of feedback to patients regarding PA levels – only to providers – and it will be interesting to discover whether providing feedback to patients can motivate them to do more physical activity,” Dr. Atwater commented.

The team is currently enrolling patients in a follow-up trial, in which patients will be given feedback from their ICD “to move these data from an interesting observation to something that can drive outcomes,” he said.

Commenting for this news organization, Melissa Tracy, MD, Rush University Medical Center, Chicago, said the study reiterates the “profound” underutilization of CR.

“Only about 3% of patients who should have qualified for cardiac rehabilitation actually attended, which is startling considering that it has class 1A level of evidence supporting its use,” she said.

Dr. Tracy, who is also a member of the American College of Cardiology’s Prevention of Cardiovascular Disease Section Leadership Council, described the study as “another notch in the belt of positive outcomes supporting the need for cardiac rehabilitation” and emphasizing the importance of a home-based alternative.

“One of the reasons women, minorities, and older patients don’t go to cardiac rehabilitation is they have to get there, rely on someone to drive them, or they have other responsibilities – especially women, who are often primary caretakers of others,” she said. “For women and men, the pressure to get back to work and support their families means they don’t have the luxury to go to cardiac rehabilitation.”

Dr. Tracy noted that home-based CR is covered by CMS until the end of 2021. “An important take-home is for providers and patients to understand that they do have a home-based option,” she stated.

Limitations of the study are that only 24% of patients were women, only 6% were Black, and the results might not be generalizable to patients younger than 65 years, note Dr. Atwater and colleagues. Also, previous implantation might have protected the cohort from experiencing arrhythmic death, and it remains unclear if similar results would be obtained in patients without a previous ICD.

This research was funded through the unrestricted Abbott Medical-Duke Health Strategic Alliance Research Grant. Dr. Atwater receives significant research support from Boston Scientific and Abbott Medical, and modest honoraria from Abbott Medical, Medtronic, and Biotronik. Coauthor disclosures are listed in the paper. Dr. Tracy has created cardiac prevention programs with Virtual Health Partners (VHP) and owns the intellectual property and consults with VHP but receives no monetary compensation.
 

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

Small increases in daily physical activity are associated with a boost in 1-year survival in patients with heart failure and coronary disease who received an implantable cardioverter defibrillator (ICD), new research suggests.

“Our study looked at how much exercise was necessary for a better outcome in patients with prior ICD implantation and, for every 10 minutes of exercise, we saw a 1% reduction in the likelihood of death or hospitalization, which is a pretty profound impact on outcome for just a small amount of additional physical activity per day,” lead author Brett Atwater, MD, told this news organization.

“These improvements were achieved outside of a formal cardiac rehabilitation program, suggesting that the benefits of increased physical activity obtained in cardiac rehabilitation programs may also be achievable at home,” he said.

Cardiac rehabilitation (CR) programs have been shown to improve short- and long-term outcomes in patients with heart failure (HF) but continue to be underutilized, especially by women, the elderly, and minorities. Home-based CR could help overcome this limitation but the science behind it is relatively new, noted Dr. Atwater, director of electrophysiology and electrophysiology research, Inova Heart and Vascular Institute, Fairfax, Va.

As reported in Circulation Cardiovascular Quality and Outcomes, the study involved 41,731 Medicare beneficiaries (mean age, 73.5 years) who received an ICD from 2014 to 2016.

ICD heart rate and activity sensor measurements were used to establish a personalized physical activity (PA) threshold for each patient in the first 3 weeks after ICD implantation. Thereafter, the ICD logged PA when the personalized PA threshold was exceeded. The mean baseline PA level was 128.9 minutes/day.

At 3 years’ follow-up, one-quarter of the patients had died and half had been hospitalized for HF. Of the total population, only 3.2% participated in CR.

Compared with nonparticipants, CR participants were more likely to be White (91.0% versus 87.3%), male (75.5% versus 72.2%), and to have diabetes (48.8% versus 44.1%), ischemic heart disease (91.4% versus 82.1%), or congestive heart failure (90.4% versus 83.4%).

CR participants attended a median of 24 sessions, during which time daily PA increased by a mean of 9.7 minutes per day. During the same time, PA decreased by a mean of 1.0 minute per day in non-CR participants (P < .001).

PA levels remained “relatively constant” for the first 36 months of follow-up among CR participants before showing a steep decline, whereas levels gradually declined throughout follow-up among nonparticipants, with a median annual change of –4.5 min/day.

In adjusted analysis, every 10 minutes of increased daily PA was associated with a 1.1% reduced risk for death (hazard ratio, 0.989; 95% confidence interval, 0.979-0.996) and a 1% reduced risk for HF hospitalization (HR, 0.99; 95% CI, 0.986-0.995) at 1-year follow-up (P < .001).

After propensity score was used to match CR participants with nonparticipants by demographic characteristics, comorbidities, and baseline PA level, CR participants had a significantly lower risk for death at 1 year (HR, 0.76; 95% CI, 0.69-0.85). This difference in risk remained at 2- and 3-year follow-ups.

However, when the researchers further adjusted for change in PA during CR or the same time period after device implantation, no differences in mortality were found between CR participants and nonparticipants at 1 year (HR, 1.00; 95% CI, 0.82-1.21) or at 2 or 3 years.

The risk for HF hospitalization did not differ between the two groups in either propensity score model.

Unlike wearable devices, implanted devices “don’t give that type of feedback to patients regarding PA levels – only to providers – and it will be interesting to discover whether providing feedback to patients can motivate them to do more physical activity,” Dr. Atwater commented.

The team is currently enrolling patients in a follow-up trial, in which patients will be given feedback from their ICD “to move these data from an interesting observation to something that can drive outcomes,” he said.

Commenting for this news organization, Melissa Tracy, MD, Rush University Medical Center, Chicago, said the study reiterates the “profound” underutilization of CR.

“Only about 3% of patients who should have qualified for cardiac rehabilitation actually attended, which is startling considering that it has class 1A level of evidence supporting its use,” she said.

Dr. Tracy, who is also a member of the American College of Cardiology’s Prevention of Cardiovascular Disease Section Leadership Council, described the study as “another notch in the belt of positive outcomes supporting the need for cardiac rehabilitation” and emphasizing the importance of a home-based alternative.

“One of the reasons women, minorities, and older patients don’t go to cardiac rehabilitation is they have to get there, rely on someone to drive them, or they have other responsibilities – especially women, who are often primary caretakers of others,” she said. “For women and men, the pressure to get back to work and support their families means they don’t have the luxury to go to cardiac rehabilitation.”

Dr. Tracy noted that home-based CR is covered by CMS until the end of 2021. “An important take-home is for providers and patients to understand that they do have a home-based option,” she stated.

Limitations of the study are that only 24% of patients were women, only 6% were Black, and the results might not be generalizable to patients younger than 65 years, note Dr. Atwater and colleagues. Also, previous implantation might have protected the cohort from experiencing arrhythmic death, and it remains unclear if similar results would be obtained in patients without a previous ICD.

This research was funded through the unrestricted Abbott Medical-Duke Health Strategic Alliance Research Grant. Dr. Atwater receives significant research support from Boston Scientific and Abbott Medical, and modest honoraria from Abbott Medical, Medtronic, and Biotronik. Coauthor disclosures are listed in the paper. Dr. Tracy has created cardiac prevention programs with Virtual Health Partners (VHP) and owns the intellectual property and consults with VHP but receives no monetary compensation.
 

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

A proinflammatory diet, as measured by the dietary inflammatory index (DII), is associated with increased risk of all-cause dementia, although not Alzheimer’s disease, according to a new analysis of longitudinal data from the Framingham Heart Study Offspring Cohort.

The lack of an association with Alzheimer’s disease was a surprise because amyloid-beta prompts microglia and astrocytes to release markers of systemic inflammation, according to Debora Melo van Lent, PhD, who is a postdoctoral fellow at the University of Texas Health San Antonio – Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases. “We expected to see a relationship between higher DII scores and an increased risk for incident Alzheimer’s disease,” said Dr. Melo van Lent, who presented the findings at the 2021 Alzheimer’s Association International Conference.

Dr. Melo van Lent added that the most likely explanation is that the study was underpowered to produce a positive association, and the team is conducting further study in a larger population.
 

A modifiable risk factor

The study is the first to look at all-cause dementia and Alzheimer’s disease dementia and their association with DII, Dr. Melo van Lent said.

“As diet is a modifiable risk factor, we can actually do something about it. If we take a closer look at five components of the DII which are most anti-inflammatory, these components are present in green leafy vegetables, vegetables, fruit, soy, whole grains, and green and black tea. Most of these components are included in the Mediterranean diet. When we look at the three most proinflammatory components, they are present in high caloric products; such as butter or margarine, pastries and sweets, fried snacks, and red or processed meat. These components are present in ‘Western diets,’ which are discouraged,” said Dr. Melo van Lent.

The researchers analyzed data from 1,486 participants who were free of dementia, stroke, or other neurologic diseases at baseline. They analyzed DII scores both in a continuous range and divided into quartiles, using the first quartile as a reference.

The mean age of participants was 69 years, and 53% were women. During follow-up, 11.3% developed AD dementia, and 14.8% developed non-AD dementia.

In the continuous model, DII was associated with increased risk of all-cause dementia after adjusting for age, sex, APOE E4 status, body mass index, smoking, physical activity index score, total energy intake, lipid-lowering medications, and total cholesterol to HDL cholesterol ratio (hazard ratio, 1.18; P =.001). In the quartile analysis, after adjustments, compared with quartile 1, there was an increased risk of all-cause dementia for those in quartile 3 (HR, 1.69; P =.020) and quartile 4 (HR, 1.84; P =.013).

In the continuous analysis, after adjustments, there was an association between DII score and Alzheimer’s dementia (HR, 1.15; P =.020). In the quartile analysis, no associations were significant, though there was a trend of quartile 4 versus quartile 1 (HR, 1.65; P =.077).

The researchers found no significant interactions between higher DII scores and sex, the APOE E4 allele, or physical activity with respect to all-cause dementia or Alzheimer’s dementia.
 

Intertwined variables

The results were interesting, but cause and effect relationships can be difficult to tease out from such a study, according to Claire Sexton, DPhil, director of scientific programs and outreach at the Alzheimer’s Association, who was asked to comment on the study. Dr. Sexton noted that individuals who eat well are more likely to have energy to exercise, which could in turn help them to sleep better, and all of those factors could be involved in reducing dementia risk. “They’re all kind of intertwined. So in this study, they were taking into account physical activity, but they can’t take into account every single variable. It’s important for them to be followed up by randomized control trials.”

Dr. Sexton also referenced the U.S. Pointer study being conducted by the Alzheimer’s Association, which is examining various interventions related to diet, physical activity, and cognitive stimulation. “Whether intervening and improving people’s health behaviors then goes on to reduce their risk for dementia is a key question. We still need more results from studies to be reporting out before we get definitive answers,” she said.

The study was funded by the ASPEN Rhoads Research Foundation. Dr. Melo van Lent and Dr. Sexton have no relevant financial disclosures.

A proinflammatory diet, as measured by the dietary inflammatory index (DII), is associated with increased risk of all-cause dementia, although not Alzheimer’s disease, according to a new analysis of longitudinal data from the Framingham Heart Study Offspring Cohort.

The lack of an association with Alzheimer’s disease was a surprise because amyloid-beta prompts microglia and astrocytes to release markers of systemic inflammation, according to Debora Melo van Lent, PhD, who is a postdoctoral fellow at the University of Texas Health San Antonio – Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases. “We expected to see a relationship between higher DII scores and an increased risk for incident Alzheimer’s disease,” said Dr. Melo van Lent, who presented the findings at the 2021 Alzheimer’s Association International Conference.

Dr. Melo van Lent added that the most likely explanation is that the study was underpowered to produce a positive association, and the team is conducting further study in a larger population.
 

A modifiable risk factor

The study is the first to look at all-cause dementia and Alzheimer’s disease dementia and their association with DII, Dr. Melo van Lent said.

“As diet is a modifiable risk factor, we can actually do something about it. If we take a closer look at five components of the DII which are most anti-inflammatory, these components are present in green leafy vegetables, vegetables, fruit, soy, whole grains, and green and black tea. Most of these components are included in the Mediterranean diet. When we look at the three most proinflammatory components, they are present in high caloric products; such as butter or margarine, pastries and sweets, fried snacks, and red or processed meat. These components are present in ‘Western diets,’ which are discouraged,” said Dr. Melo van Lent.

The researchers analyzed data from 1,486 participants who were free of dementia, stroke, or other neurologic diseases at baseline. They analyzed DII scores both in a continuous range and divided into quartiles, using the first quartile as a reference.

The mean age of participants was 69 years, and 53% were women. During follow-up, 11.3% developed AD dementia, and 14.8% developed non-AD dementia.

In the continuous model, DII was associated with increased risk of all-cause dementia after adjusting for age, sex, APOE E4 status, body mass index, smoking, physical activity index score, total energy intake, lipid-lowering medications, and total cholesterol to HDL cholesterol ratio (hazard ratio, 1.18; P =.001). In the quartile analysis, after adjustments, compared with quartile 1, there was an increased risk of all-cause dementia for those in quartile 3 (HR, 1.69; P =.020) and quartile 4 (HR, 1.84; P =.013).

In the continuous analysis, after adjustments, there was an association between DII score and Alzheimer’s dementia (HR, 1.15; P =.020). In the quartile analysis, no associations were significant, though there was a trend of quartile 4 versus quartile 1 (HR, 1.65; P =.077).

The researchers found no significant interactions between higher DII scores and sex, the APOE E4 allele, or physical activity with respect to all-cause dementia or Alzheimer’s dementia.
 

Intertwined variables

The results were interesting, but cause and effect relationships can be difficult to tease out from such a study, according to Claire Sexton, DPhil, director of scientific programs and outreach at the Alzheimer’s Association, who was asked to comment on the study. Dr. Sexton noted that individuals who eat well are more likely to have energy to exercise, which could in turn help them to sleep better, and all of those factors could be involved in reducing dementia risk. “They’re all kind of intertwined. So in this study, they were taking into account physical activity, but they can’t take into account every single variable. It’s important for them to be followed up by randomized control trials.”

Dr. Sexton also referenced the U.S. Pointer study being conducted by the Alzheimer’s Association, which is examining various interventions related to diet, physical activity, and cognitive stimulation. “Whether intervening and improving people’s health behaviors then goes on to reduce their risk for dementia is a key question. We still need more results from studies to be reporting out before we get definitive answers,” she said.

The study was funded by the ASPEN Rhoads Research Foundation. Dr. Melo van Lent and Dr. Sexton have no relevant financial disclosures.

A proinflammatory diet, as measured by the dietary inflammatory index (DII), is associated with increased risk of all-cause dementia, although not Alzheimer’s disease, according to a new analysis of longitudinal data from the Framingham Heart Study Offspring Cohort.

The lack of an association with Alzheimer’s disease was a surprise because amyloid-beta prompts microglia and astrocytes to release markers of systemic inflammation, according to Debora Melo van Lent, PhD, who is a postdoctoral fellow at the University of Texas Health San Antonio – Glenn Biggs Institute for Alzheimer’s and Neurodegenerative Diseases. “We expected to see a relationship between higher DII scores and an increased risk for incident Alzheimer’s disease,” said Dr. Melo van Lent, who presented the findings at the 2021 Alzheimer’s Association International Conference.

Dr. Melo van Lent added that the most likely explanation is that the study was underpowered to produce a positive association, and the team is conducting further study in a larger population.
 

A modifiable risk factor

The study is the first to look at all-cause dementia and Alzheimer’s disease dementia and their association with DII, Dr. Melo van Lent said.

“As diet is a modifiable risk factor, we can actually do something about it. If we take a closer look at five components of the DII which are most anti-inflammatory, these components are present in green leafy vegetables, vegetables, fruit, soy, whole grains, and green and black tea. Most of these components are included in the Mediterranean diet. When we look at the three most proinflammatory components, they are present in high caloric products; such as butter or margarine, pastries and sweets, fried snacks, and red or processed meat. These components are present in ‘Western diets,’ which are discouraged,” said Dr. Melo van Lent.

The researchers analyzed data from 1,486 participants who were free of dementia, stroke, or other neurologic diseases at baseline. They analyzed DII scores both in a continuous range and divided into quartiles, using the first quartile as a reference.

The mean age of participants was 69 years, and 53% were women. During follow-up, 11.3% developed AD dementia, and 14.8% developed non-AD dementia.

In the continuous model, DII was associated with increased risk of all-cause dementia after adjusting for age, sex, APOE E4 status, body mass index, smoking, physical activity index score, total energy intake, lipid-lowering medications, and total cholesterol to HDL cholesterol ratio (hazard ratio, 1.18; P =.001). In the quartile analysis, after adjustments, compared with quartile 1, there was an increased risk of all-cause dementia for those in quartile 3 (HR, 1.69; P =.020) and quartile 4 (HR, 1.84; P =.013).

In the continuous analysis, after adjustments, there was an association between DII score and Alzheimer’s dementia (HR, 1.15; P =.020). In the quartile analysis, no associations were significant, though there was a trend of quartile 4 versus quartile 1 (HR, 1.65; P =.077).

The researchers found no significant interactions between higher DII scores and sex, the APOE E4 allele, or physical activity with respect to all-cause dementia or Alzheimer’s dementia.
 

Intertwined variables

The results were interesting, but cause and effect relationships can be difficult to tease out from such a study, according to Claire Sexton, DPhil, director of scientific programs and outreach at the Alzheimer’s Association, who was asked to comment on the study. Dr. Sexton noted that individuals who eat well are more likely to have energy to exercise, which could in turn help them to sleep better, and all of those factors could be involved in reducing dementia risk. “They’re all kind of intertwined. So in this study, they were taking into account physical activity, but they can’t take into account every single variable. It’s important for them to be followed up by randomized control trials.”

Dr. Sexton also referenced the U.S. Pointer study being conducted by the Alzheimer’s Association, which is examining various interventions related to diet, physical activity, and cognitive stimulation. “Whether intervening and improving people’s health behaviors then goes on to reduce their risk for dementia is a key question. We still need more results from studies to be reporting out before we get definitive answers,” she said.

The study was funded by the ASPEN Rhoads Research Foundation. Dr. Melo van Lent and Dr. Sexton have no relevant financial disclosures.