Obesity

People with obesity who have inherited “lucky genes” for a favorable distribution of body fat had a lower risk of 11 diseases related to the metabolic effects of fat, compared with people who had inherited “unlucky genes,” in a large new genetics study.

That is, people with unfavorable adiposity gene variants had fat stored under the skin throughout the body, but they also had more ectopic fat (fat in the “wrong place”) surrounding the pancreas and liver, which is associated with a higher risk of metabolic diseases such as heart disease and type 2 diabetes.

In contrast, people with favorable adiposity gene variants had more subcutaneous fat (such as a paunch or a double chin).

The study by Susan Martin, PhD, a postdoctoral research associate at the University of Exeter (England) and colleagues, was recently published in eLife.

“Some people have ‘unlucky fat genes,’ meaning they store higher levels of fat everywhere, including under the skin [and around the] liver and pancreas. That’s associated with a higher risk of diseases such as type 2 diabetes,” senior author Hanieh Yaghootkar, MD, PhD, summarized in a press release from the University of Exeter.

“Others are luckier and have genes that mean higher fat under the skin but lower liver fat and a lower risk of diseases like type 2 diabetes,” added Dr. Yaghootkar, from Brunel University London.

Among 37 chronic diseases that are associated with obesity, the researchers found the metabolic effects of adiposity are likely the main cause of the following 11: type 2 diabetes, polycystic ovary syndrome, coronary artery disease, peripheral artery disease, hypertension, stroke, heart failure, atrial fibrillation, chronic kidney disease, renal cancer, and gout.

On the other hand, excess weight itself (such as a heavy load on the joints) rather than a metabolic effect is associated with nine other obesity-related diseases: osteoarthritis, rheumatoid arthritis, osteoporosis, gastro-esophageal reflux disease, gallstones, adult-onset asthma, psoriasis, deep vein thrombosis, and venous thromboembolism.    
 

Good genes no substitute for a healthy lifestyle

“People with more favorable adiposity gene variants are still at risk of the nine diseases” that are not caused by metabolic effects – such as osteoarthritis – but are caused by the effect of excess weight on the joints, another  author, Timothy M. Frayling, PhD, stressed.

“People with obesity and unfavorable adiposity gene variants are at higher risk of all 20 diseases because they have the double hit of the excess mechanical effects and the adverse metabolic effects,” Dr. Frayling of the University of Exeter, told this news organization in an email.

The main clinical message, he said, is that “this research helps inform which conditions may respond better to therapies that lower the adverse effects” of risk factors such as high cholesterol and blood glucose levels, “and high blood pressure, even with no weight loss.”

“In contrast, other conditions really require the weight loss.”

“These results emphasize that many people in the community who are of higher body mass index are at risk of multiple chronic conditions that can severely impair their quality of life or cause morbidity or mortality, even if their metabolic parameters appear relatively normal,” the researchers conclude.

“Whilst it’s important that we identify the causes of obesity-related disease, good genes [are] still no substitute for a healthy lifestyle,” Dr. Martin stressed.

“A favorable adiposity will only go so far. If you’re obese, the advice is to still try and shift the excess weight where you can,” she said.

“The authors have conducted a robust and very comprehensive study using Mendelian randomization to disentangle metabolic and nonmetabolic effects of overweight on a long list of disease outcomes,” reviewing editor Edward D. Janus, MD, PhD, of the University of Melbourne summarized.

“This is an important topic and can help us better understand how overweight influences risk of several important outcomes.”
 

Metabolic and nonmetabolic diseases caused by obesity

The researchers aimed to investigate the effects of adiposity on metabolic and nonmetabolic diseases caused by obesity.

They used data from 176,899 individuals in the FinnGen project in Finland and from over 500,000 individuals in the UK Biobank database.

They performed Mendelian randomization studies to investigate the causal association between BMI, body fat percentage, favorable adiposity alleles, and unfavorable adiposity alleles with 37 disease outcomes.

Of these 37 chronic diseases associated with obesity, 11 diseases were directly related to the metabolic effect of adiposity (where favorable adiposity or unfavorable adiposity gene variants had opposite effects). Nine other diseases were unrelated to the metabolic effects of adiposity.

For most of the remaining diseases – for example, Alzheimer’s disease and different cancers – it was difficult to draw firm conclusions about the respective roles of favorable adiposity and unfavorable adiposity gene variants.

The study was funded by Diabetes UK, the UK Medical Research Council, the World Cancer Research Fund, and the National Cancer Institute. Author disclosures are listed with the article.

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

People with obesity who have inherited “lucky genes” for a favorable distribution of body fat had a lower risk of 11 diseases related to the metabolic effects of fat, compared with people who had inherited “unlucky genes,” in a large new genetics study.

That is, people with unfavorable adiposity gene variants had fat stored under the skin throughout the body, but they also had more ectopic fat (fat in the “wrong place”) surrounding the pancreas and liver, which is associated with a higher risk of metabolic diseases such as heart disease and type 2 diabetes.

In contrast, people with favorable adiposity gene variants had more subcutaneous fat (such as a paunch or a double chin).

The study by Susan Martin, PhD, a postdoctoral research associate at the University of Exeter (England) and colleagues, was recently published in eLife.

“Some people have ‘unlucky fat genes,’ meaning they store higher levels of fat everywhere, including under the skin [and around the] liver and pancreas. That’s associated with a higher risk of diseases such as type 2 diabetes,” senior author Hanieh Yaghootkar, MD, PhD, summarized in a press release from the University of Exeter.

“Others are luckier and have genes that mean higher fat under the skin but lower liver fat and a lower risk of diseases like type 2 diabetes,” added Dr. Yaghootkar, from Brunel University London.

Among 37 chronic diseases that are associated with obesity, the researchers found the metabolic effects of adiposity are likely the main cause of the following 11: type 2 diabetes, polycystic ovary syndrome, coronary artery disease, peripheral artery disease, hypertension, stroke, heart failure, atrial fibrillation, chronic kidney disease, renal cancer, and gout.

On the other hand, excess weight itself (such as a heavy load on the joints) rather than a metabolic effect is associated with nine other obesity-related diseases: osteoarthritis, rheumatoid arthritis, osteoporosis, gastro-esophageal reflux disease, gallstones, adult-onset asthma, psoriasis, deep vein thrombosis, and venous thromboembolism.    
 

Good genes no substitute for a healthy lifestyle

“People with more favorable adiposity gene variants are still at risk of the nine diseases” that are not caused by metabolic effects – such as osteoarthritis – but are caused by the effect of excess weight on the joints, another  author, Timothy M. Frayling, PhD, stressed.

“People with obesity and unfavorable adiposity gene variants are at higher risk of all 20 diseases because they have the double hit of the excess mechanical effects and the adverse metabolic effects,” Dr. Frayling of the University of Exeter, told this news organization in an email.

The main clinical message, he said, is that “this research helps inform which conditions may respond better to therapies that lower the adverse effects” of risk factors such as high cholesterol and blood glucose levels, “and high blood pressure, even with no weight loss.”

“In contrast, other conditions really require the weight loss.”

“These results emphasize that many people in the community who are of higher body mass index are at risk of multiple chronic conditions that can severely impair their quality of life or cause morbidity or mortality, even if their metabolic parameters appear relatively normal,” the researchers conclude.

“Whilst it’s important that we identify the causes of obesity-related disease, good genes [are] still no substitute for a healthy lifestyle,” Dr. Martin stressed.

“A favorable adiposity will only go so far. If you’re obese, the advice is to still try and shift the excess weight where you can,” she said.

“The authors have conducted a robust and very comprehensive study using Mendelian randomization to disentangle metabolic and nonmetabolic effects of overweight on a long list of disease outcomes,” reviewing editor Edward D. Janus, MD, PhD, of the University of Melbourne summarized.

“This is an important topic and can help us better understand how overweight influences risk of several important outcomes.”
 

Metabolic and nonmetabolic diseases caused by obesity

The researchers aimed to investigate the effects of adiposity on metabolic and nonmetabolic diseases caused by obesity.

They used data from 176,899 individuals in the FinnGen project in Finland and from over 500,000 individuals in the UK Biobank database.

They performed Mendelian randomization studies to investigate the causal association between BMI, body fat percentage, favorable adiposity alleles, and unfavorable adiposity alleles with 37 disease outcomes.

Of these 37 chronic diseases associated with obesity, 11 diseases were directly related to the metabolic effect of adiposity (where favorable adiposity or unfavorable adiposity gene variants had opposite effects). Nine other diseases were unrelated to the metabolic effects of adiposity.

For most of the remaining diseases – for example, Alzheimer’s disease and different cancers – it was difficult to draw firm conclusions about the respective roles of favorable adiposity and unfavorable adiposity gene variants.

The study was funded by Diabetes UK, the UK Medical Research Council, the World Cancer Research Fund, and the National Cancer Institute. Author disclosures are listed with the article.

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

People with obesity who have inherited “lucky genes” for a favorable distribution of body fat had a lower risk of 11 diseases related to the metabolic effects of fat, compared with people who had inherited “unlucky genes,” in a large new genetics study.

That is, people with unfavorable adiposity gene variants had fat stored under the skin throughout the body, but they also had more ectopic fat (fat in the “wrong place”) surrounding the pancreas and liver, which is associated with a higher risk of metabolic diseases such as heart disease and type 2 diabetes.

In contrast, people with favorable adiposity gene variants had more subcutaneous fat (such as a paunch or a double chin).

The study by Susan Martin, PhD, a postdoctoral research associate at the University of Exeter (England) and colleagues, was recently published in eLife.

“Some people have ‘unlucky fat genes,’ meaning they store higher levels of fat everywhere, including under the skin [and around the] liver and pancreas. That’s associated with a higher risk of diseases such as type 2 diabetes,” senior author Hanieh Yaghootkar, MD, PhD, summarized in a press release from the University of Exeter.

“Others are luckier and have genes that mean higher fat under the skin but lower liver fat and a lower risk of diseases like type 2 diabetes,” added Dr. Yaghootkar, from Brunel University London.

Among 37 chronic diseases that are associated with obesity, the researchers found the metabolic effects of adiposity are likely the main cause of the following 11: type 2 diabetes, polycystic ovary syndrome, coronary artery disease, peripheral artery disease, hypertension, stroke, heart failure, atrial fibrillation, chronic kidney disease, renal cancer, and gout.

On the other hand, excess weight itself (such as a heavy load on the joints) rather than a metabolic effect is associated with nine other obesity-related diseases: osteoarthritis, rheumatoid arthritis, osteoporosis, gastro-esophageal reflux disease, gallstones, adult-onset asthma, psoriasis, deep vein thrombosis, and venous thromboembolism.    
 

Good genes no substitute for a healthy lifestyle

“People with more favorable adiposity gene variants are still at risk of the nine diseases” that are not caused by metabolic effects – such as osteoarthritis – but are caused by the effect of excess weight on the joints, another  author, Timothy M. Frayling, PhD, stressed.

“People with obesity and unfavorable adiposity gene variants are at higher risk of all 20 diseases because they have the double hit of the excess mechanical effects and the adverse metabolic effects,” Dr. Frayling of the University of Exeter, told this news organization in an email.

The main clinical message, he said, is that “this research helps inform which conditions may respond better to therapies that lower the adverse effects” of risk factors such as high cholesterol and blood glucose levels, “and high blood pressure, even with no weight loss.”

“In contrast, other conditions really require the weight loss.”

“These results emphasize that many people in the community who are of higher body mass index are at risk of multiple chronic conditions that can severely impair their quality of life or cause morbidity or mortality, even if their metabolic parameters appear relatively normal,” the researchers conclude.

“Whilst it’s important that we identify the causes of obesity-related disease, good genes [are] still no substitute for a healthy lifestyle,” Dr. Martin stressed.

“A favorable adiposity will only go so far. If you’re obese, the advice is to still try and shift the excess weight where you can,” she said.

“The authors have conducted a robust and very comprehensive study using Mendelian randomization to disentangle metabolic and nonmetabolic effects of overweight on a long list of disease outcomes,” reviewing editor Edward D. Janus, MD, PhD, of the University of Melbourne summarized.

“This is an important topic and can help us better understand how overweight influences risk of several important outcomes.”
 

Metabolic and nonmetabolic diseases caused by obesity

The researchers aimed to investigate the effects of adiposity on metabolic and nonmetabolic diseases caused by obesity.

They used data from 176,899 individuals in the FinnGen project in Finland and from over 500,000 individuals in the UK Biobank database.

They performed Mendelian randomization studies to investigate the causal association between BMI, body fat percentage, favorable adiposity alleles, and unfavorable adiposity alleles with 37 disease outcomes.

Of these 37 chronic diseases associated with obesity, 11 diseases were directly related to the metabolic effect of adiposity (where favorable adiposity or unfavorable adiposity gene variants had opposite effects). Nine other diseases were unrelated to the metabolic effects of adiposity.

For most of the remaining diseases – for example, Alzheimer’s disease and different cancers – it was difficult to draw firm conclusions about the respective roles of favorable adiposity and unfavorable adiposity gene variants.

The study was funded by Diabetes UK, the UK Medical Research Council, the World Cancer Research Fund, and the National Cancer Institute. Author disclosures are listed with the article.

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

Metabolic adaptation – slowing of metabolism in response to weight loss – increases the length of time needed to achieve a target lower weight, a new study of premenopausal women with overweight reports.

All of the 65 sedentary young and middle-aged women with overweight who were on a low-calorie diet (800 calories/day) attained their target lower weight – corresponding to a body mass index (BMI) of 25 kg/m² or less – after 66-252 days.

But a woman with the largest metabolic adaptation needed to stay on the diet for an extra 70 days, compared with a woman with no metabolic adaptation, to reach the target BMI, after adjusting for dietary adherence.

The study by Catia Martins, PhD, and colleagues was published Jan. 27, 2022, in Obesity.

“Even though adherence to the diet is clearly the most important determinant of time to reach weight loss goals,” wrote Dr. Martins and colleagues, “the present findings are of great clinical relevance as they mean that individuals who are struggling to achieve weight-loss goals, despite assuring compliance with the diet, may indeed be ‘suffering’ from metabolic adaptation during active weight loss.”

Therefore, “clinicians need to consider metabolic adaptation when assessing resistance to weight loss,” they concluded.
 

Good news: Metabolic adaption ceases when weight stabilizes

“This study shows that a longer than expected duration of intervention to achieve weight loss targets might be due to metabolic adaptation, even after controlling for adherence to the diet,” Dr. Martins said in an interview.

Metabolic adaptation while on a diet makes it harder to lose the last pound than to lose the first pound because as weight loss progresses metabolic adaptation increases, she noted.

However, “the good news is that this mechanism disappears once weight is stabilized (a new energy balance is established), and it is not a predictor of weight regain in the long term,” noted Dr. Martins, associate professor, nutrition sciences research, University of Alabama at Birmingham.

The group published a study in 2020 showing that metabolic adaptation does not predict weight regain at 1 year, and another study, published a few months earlier, showed it is not a barrier to weight-loss maintenance.

The current study findings “provide further evidence of the ways that physiology fights back when people are trying to lose weight,” David B. Sarwer, PhD, who was not involved with this research, said in a press release from the Obesity Society.

“A countless number of environmental variables and other social determinants of health also make weight loss and maintenance challenging for many individuals,” added Dr. Sarwer, director of the Center for Obesity Research and Education at Temple University, Philadelphia.

“Nevertheless, it is import to remember that even a modest weight loss of 5% of initial body weight – much smaller than seen in this study – is associated with clinically significant improvements in weight-related health issues for many individuals,” he stressed.
 

16% weight loss at 5 weeks with 800-calorie/day diet

It is unclear whether metabolic adaptation contributes to resistance to weight loss by increasing the time necessary to achieve weight-loss goals.

To investigate this, Dr. Martins and associates analyzed data from 36 White women and 29 Black women, aged 20-41 years (mean age, 36), who had a mean BMI of 28.6 and had participated in the diet arms of two studies (ROMEO and JULIET) conducted at Martins’ institution.

Participants received food containing 20% to 22% fat, 20% to 22% protein, and 56% to 58% carbohydrate provided by the center’s research kitchen.

On average, the women were 64% compliant with the diet and lost 12.5 kg (27.6 pounds), a 16% weight loss, over 155 days.

Metabolic adaption was measured 4 weeks after weight stabilization after reaching the weight-loss target.

On average, participants’ resting metabolic rate after weight loss was 46 kcal lower than what would be expected for their lower body weight.  

Metabolic adaptation after weight loss was a significant predictor of time to reach the weight-loss goal, after adjusting for target weight loss, energy deficit, and adherence to the diet (R2 adjusted, 0.63; P < .001).

The study findings may not be generalizable to men, older patients, or people with a higher BMI, so further research is needed in a broader population, the researchers concluded.

The research was supported by National Institutes of Health grants. Dr. Martins was supported by a sabbatical grant from the Liaison Committee for Education, Research, and Innovation in Central Norway and the Norwegian University of Science and Technology. The researchers have no relevant financial disclosures.

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

Metabolic adaptation – slowing of metabolism in response to weight loss – increases the length of time needed to achieve a target lower weight, a new study of premenopausal women with overweight reports.

All of the 65 sedentary young and middle-aged women with overweight who were on a low-calorie diet (800 calories/day) attained their target lower weight – corresponding to a body mass index (BMI) of 25 kg/m² or less – after 66-252 days.

But a woman with the largest metabolic adaptation needed to stay on the diet for an extra 70 days, compared with a woman with no metabolic adaptation, to reach the target BMI, after adjusting for dietary adherence.

The study by Catia Martins, PhD, and colleagues was published Jan. 27, 2022, in Obesity.

“Even though adherence to the diet is clearly the most important determinant of time to reach weight loss goals,” wrote Dr. Martins and colleagues, “the present findings are of great clinical relevance as they mean that individuals who are struggling to achieve weight-loss goals, despite assuring compliance with the diet, may indeed be ‘suffering’ from metabolic adaptation during active weight loss.”

Therefore, “clinicians need to consider metabolic adaptation when assessing resistance to weight loss,” they concluded.
 

Good news: Metabolic adaption ceases when weight stabilizes

“This study shows that a longer than expected duration of intervention to achieve weight loss targets might be due to metabolic adaptation, even after controlling for adherence to the diet,” Dr. Martins said in an interview.

Metabolic adaptation while on a diet makes it harder to lose the last pound than to lose the first pound because as weight loss progresses metabolic adaptation increases, she noted.

However, “the good news is that this mechanism disappears once weight is stabilized (a new energy balance is established), and it is not a predictor of weight regain in the long term,” noted Dr. Martins, associate professor, nutrition sciences research, University of Alabama at Birmingham.

The group published a study in 2020 showing that metabolic adaptation does not predict weight regain at 1 year, and another study, published a few months earlier, showed it is not a barrier to weight-loss maintenance.

The current study findings “provide further evidence of the ways that physiology fights back when people are trying to lose weight,” David B. Sarwer, PhD, who was not involved with this research, said in a press release from the Obesity Society.

“A countless number of environmental variables and other social determinants of health also make weight loss and maintenance challenging for many individuals,” added Dr. Sarwer, director of the Center for Obesity Research and Education at Temple University, Philadelphia.

“Nevertheless, it is import to remember that even a modest weight loss of 5% of initial body weight – much smaller than seen in this study – is associated with clinically significant improvements in weight-related health issues for many individuals,” he stressed.
 

16% weight loss at 5 weeks with 800-calorie/day diet

It is unclear whether metabolic adaptation contributes to resistance to weight loss by increasing the time necessary to achieve weight-loss goals.

To investigate this, Dr. Martins and associates analyzed data from 36 White women and 29 Black women, aged 20-41 years (mean age, 36), who had a mean BMI of 28.6 and had participated in the diet arms of two studies (ROMEO and JULIET) conducted at Martins’ institution.

Participants received food containing 20% to 22% fat, 20% to 22% protein, and 56% to 58% carbohydrate provided by the center’s research kitchen.

On average, the women were 64% compliant with the diet and lost 12.5 kg (27.6 pounds), a 16% weight loss, over 155 days.

Metabolic adaption was measured 4 weeks after weight stabilization after reaching the weight-loss target.

On average, participants’ resting metabolic rate after weight loss was 46 kcal lower than what would be expected for their lower body weight.  

Metabolic adaptation after weight loss was a significant predictor of time to reach the weight-loss goal, after adjusting for target weight loss, energy deficit, and adherence to the diet (R2 adjusted, 0.63; P < .001).

The study findings may not be generalizable to men, older patients, or people with a higher BMI, so further research is needed in a broader population, the researchers concluded.

The research was supported by National Institutes of Health grants. Dr. Martins was supported by a sabbatical grant from the Liaison Committee for Education, Research, and Innovation in Central Norway and the Norwegian University of Science and Technology. The researchers have no relevant financial disclosures.

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

Metabolic adaptation – slowing of metabolism in response to weight loss – increases the length of time needed to achieve a target lower weight, a new study of premenopausal women with overweight reports.

All of the 65 sedentary young and middle-aged women with overweight who were on a low-calorie diet (800 calories/day) attained their target lower weight – corresponding to a body mass index (BMI) of 25 kg/m² or less – after 66-252 days.

But a woman with the largest metabolic adaptation needed to stay on the diet for an extra 70 days, compared with a woman with no metabolic adaptation, to reach the target BMI, after adjusting for dietary adherence.

The study by Catia Martins, PhD, and colleagues was published Jan. 27, 2022, in Obesity.

“Even though adherence to the diet is clearly the most important determinant of time to reach weight loss goals,” wrote Dr. Martins and colleagues, “the present findings are of great clinical relevance as they mean that individuals who are struggling to achieve weight-loss goals, despite assuring compliance with the diet, may indeed be ‘suffering’ from metabolic adaptation during active weight loss.”

Therefore, “clinicians need to consider metabolic adaptation when assessing resistance to weight loss,” they concluded.
 

Good news: Metabolic adaption ceases when weight stabilizes

“This study shows that a longer than expected duration of intervention to achieve weight loss targets might be due to metabolic adaptation, even after controlling for adherence to the diet,” Dr. Martins said in an interview.

Metabolic adaptation while on a diet makes it harder to lose the last pound than to lose the first pound because as weight loss progresses metabolic adaptation increases, she noted.

However, “the good news is that this mechanism disappears once weight is stabilized (a new energy balance is established), and it is not a predictor of weight regain in the long term,” noted Dr. Martins, associate professor, nutrition sciences research, University of Alabama at Birmingham.

The group published a study in 2020 showing that metabolic adaptation does not predict weight regain at 1 year, and another study, published a few months earlier, showed it is not a barrier to weight-loss maintenance.

The current study findings “provide further evidence of the ways that physiology fights back when people are trying to lose weight,” David B. Sarwer, PhD, who was not involved with this research, said in a press release from the Obesity Society.

“A countless number of environmental variables and other social determinants of health also make weight loss and maintenance challenging for many individuals,” added Dr. Sarwer, director of the Center for Obesity Research and Education at Temple University, Philadelphia.

“Nevertheless, it is import to remember that even a modest weight loss of 5% of initial body weight – much smaller than seen in this study – is associated with clinically significant improvements in weight-related health issues for many individuals,” he stressed.
 

16% weight loss at 5 weeks with 800-calorie/day diet

It is unclear whether metabolic adaptation contributes to resistance to weight loss by increasing the time necessary to achieve weight-loss goals.

To investigate this, Dr. Martins and associates analyzed data from 36 White women and 29 Black women, aged 20-41 years (mean age, 36), who had a mean BMI of 28.6 and had participated in the diet arms of two studies (ROMEO and JULIET) conducted at Martins’ institution.

Participants received food containing 20% to 22% fat, 20% to 22% protein, and 56% to 58% carbohydrate provided by the center’s research kitchen.

On average, the women were 64% compliant with the diet and lost 12.5 kg (27.6 pounds), a 16% weight loss, over 155 days.

Metabolic adaption was measured 4 weeks after weight stabilization after reaching the weight-loss target.

On average, participants’ resting metabolic rate after weight loss was 46 kcal lower than what would be expected for their lower body weight.  

Metabolic adaptation after weight loss was a significant predictor of time to reach the weight-loss goal, after adjusting for target weight loss, energy deficit, and adherence to the diet (R2 adjusted, 0.63; P < .001).

The study findings may not be generalizable to men, older patients, or people with a higher BMI, so further research is needed in a broader population, the researchers concluded.

The research was supported by National Institutes of Health grants. Dr. Martins was supported by a sabbatical grant from the Liaison Committee for Education, Research, and Innovation in Central Norway and the Norwegian University of Science and Technology. The researchers have no relevant financial disclosures.

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

More than 1 in 10 Americans have diabetes and over a third have prediabetes, according to updated statistics from the Centers for Disease Control and Prevention.

The National Diabetes Statistics Report includes data for 2017-2020 from several nationally representative sources on prevalence and incidence of diabetes and prediabetes, risk factors for complications, acute and long-term complications, and costs.

According to the new report, published on Jan. 25, a total of 37.3 million people in the United States have diabetes, or about 11.3% of the population. Of those, 28.7 million are diagnosed (including 28.5 million adults), while 8.5 million, or 23% of those with diabetes, are undiagnosed.

Another 96 million adults have prediabetes, comprising 38.0% of the adult U.S. population, of whom only 19% are aware of their prediabetes status.

In a statement, the American Diabetes Association said the new CDC data “show an alarming increase of diabetes in our nation among adults,” while the high number with prediabetes who don’t know that they have it “is fueling the diabetes epidemic.”

Regarding the total estimated 1.84 million with type 1 diabetes, the advocacy organization JDRF said in a statement: “These data and additional statistical research reinforces the urgency to accelerate life-changing breakthroughs to cure, prevent, and treat [type 1 diabetes] and its complications.”

Overall, the ADA said, “the National Diabetes Statistics Report reaffirms why the ADA is dedicated to innovative research to find a cure for diabetes once and for all.”
 

Notable increases since 2019

These new data represent notable increases since the CDC’s 2019 Report Card, which gave the U.S. population with diabetes in 2018 as 34.2 million, or 10.5% of the population, including 7.3 million undiagnosed. The prediabetes prevalence that year was 88 million.

Among children and adolescents younger than 20 years, 283,000, or 35 per 10,000 U.S. youths, had diagnosed diabetes in 2019. Of those, 244,000 had type 1 diabetes. Another 1.6 million adults aged 20 and older also reported having type 1 diabetes, comprising 5.7% of U.S. adults with diagnosed diabetes.

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

More than 1 in 10 Americans have diabetes and over a third have prediabetes, according to updated statistics from the Centers for Disease Control and Prevention.

The National Diabetes Statistics Report includes data for 2017-2020 from several nationally representative sources on prevalence and incidence of diabetes and prediabetes, risk factors for complications, acute and long-term complications, and costs.

According to the new report, published on Jan. 25, a total of 37.3 million people in the United States have diabetes, or about 11.3% of the population. Of those, 28.7 million are diagnosed (including 28.5 million adults), while 8.5 million, or 23% of those with diabetes, are undiagnosed.

Another 96 million adults have prediabetes, comprising 38.0% of the adult U.S. population, of whom only 19% are aware of their prediabetes status.

In a statement, the American Diabetes Association said the new CDC data “show an alarming increase of diabetes in our nation among adults,” while the high number with prediabetes who don’t know that they have it “is fueling the diabetes epidemic.”

Regarding the total estimated 1.84 million with type 1 diabetes, the advocacy organization JDRF said in a statement: “These data and additional statistical research reinforces the urgency to accelerate life-changing breakthroughs to cure, prevent, and treat [type 1 diabetes] and its complications.”

Overall, the ADA said, “the National Diabetes Statistics Report reaffirms why the ADA is dedicated to innovative research to find a cure for diabetes once and for all.”
 

Notable increases since 2019

These new data represent notable increases since the CDC’s 2019 Report Card, which gave the U.S. population with diabetes in 2018 as 34.2 million, or 10.5% of the population, including 7.3 million undiagnosed. The prediabetes prevalence that year was 88 million.

Among children and adolescents younger than 20 years, 283,000, or 35 per 10,000 U.S. youths, had diagnosed diabetes in 2019. Of those, 244,000 had type 1 diabetes. Another 1.6 million adults aged 20 and older also reported having type 1 diabetes, comprising 5.7% of U.S. adults with diagnosed diabetes.

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

More than 1 in 10 Americans have diabetes and over a third have prediabetes, according to updated statistics from the Centers for Disease Control and Prevention.

The National Diabetes Statistics Report includes data for 2017-2020 from several nationally representative sources on prevalence and incidence of diabetes and prediabetes, risk factors for complications, acute and long-term complications, and costs.

According to the new report, published on Jan. 25, a total of 37.3 million people in the United States have diabetes, or about 11.3% of the population. Of those, 28.7 million are diagnosed (including 28.5 million adults), while 8.5 million, or 23% of those with diabetes, are undiagnosed.

Another 96 million adults have prediabetes, comprising 38.0% of the adult U.S. population, of whom only 19% are aware of their prediabetes status.

In a statement, the American Diabetes Association said the new CDC data “show an alarming increase of diabetes in our nation among adults,” while the high number with prediabetes who don’t know that they have it “is fueling the diabetes epidemic.”

Regarding the total estimated 1.84 million with type 1 diabetes, the advocacy organization JDRF said in a statement: “These data and additional statistical research reinforces the urgency to accelerate life-changing breakthroughs to cure, prevent, and treat [type 1 diabetes] and its complications.”

Overall, the ADA said, “the National Diabetes Statistics Report reaffirms why the ADA is dedicated to innovative research to find a cure for diabetes once and for all.”
 

Notable increases since 2019

These new data represent notable increases since the CDC’s 2019 Report Card, which gave the U.S. population with diabetes in 2018 as 34.2 million, or 10.5% of the population, including 7.3 million undiagnosed. The prediabetes prevalence that year was 88 million.

Among children and adolescents younger than 20 years, 283,000, or 35 per 10,000 U.S. youths, had diagnosed diabetes in 2019. Of those, 244,000 had type 1 diabetes. Another 1.6 million adults aged 20 and older also reported having type 1 diabetes, comprising 5.7% of U.S. adults with diagnosed diabetes.

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

More steps per day, particularly at a higher intensity, may reduce the risk of type 2 diabetes in older women, based on a prospective cohort study.

The link between daily stepping and diabetes was not significantly modified by body mass index (BMI) or other common diabetes risk factors, suggesting that the relationship is highly generalizable, lead author Alexis C. Garduno, MPH, a PhD student at the University of California, San Diego, and colleagues reported.

“Physical activity is a key modifiable behavior for diabetes prevention and management,” the investigators wrote in Diabetes Care. “Many prevention studies have demonstrated that regular physical activity, along with improved diet, reduces the risk of diabetes in adults. ... To the best of our knowledge, there are few studies examining the association between objectively measured steps per day and incident diabetes in a community-based setting.”

To this end, the investigators analyzed data from 4,838 older, community-living women in the Objective Physical Activity and Cardiovascular Health Study. Upon enrollment, women were without physician-diagnosed diabetes and had a mean age of 78.9 years. For 1 week, participants wore ActiGraph GT3X+ accelerometers to measure steps per day, as well as step intensity, graded as light or moderate to vigorous.

The relationship between daily activity and diabetes was analyzed using three multivariate models: The first included race/ethnicity and age; the second also included family history of diabetes, education, physical functioning, self-rated health, smoking status, and alcohol consumption; and the third added BMI, “a potential mediator in the causal pathway between steps per day and diabetes,” the investigators wrote.

Participants took an average of 3,729 steps per day, divided roughly evenly between light and moderate to vigorous intensity.

After a median follow-up of 5.7 years, 8.1% of women developed diabetes. The least-adjusted model showed a 14% reduction in diabetes risk per 2,000 steps (hazard ratio, 0.86; 95% confidence interval, 0.80-0.92; P = .007), whereas the second model, adjusting for more confounding variables, showed a 12% reduction in diabetes risk per 2,000 steps (HR, 0.88; 95% CI, 0.78-1.00; P = .045).

The final model, which added BMI, showed a 10% reduction in risk, although it didn’t reach statistical significance (HR, 0.90; 95% CI, 0.80-1.02; P = .11). Furthermore, accelerated failure time models suggested that BMI did not significantly impact the link between steps and diabetes (proportion mediated, 17.7%;95% CI, –55.0 to 142.0; P = .09). Further analyses also found no significant interactions between BMI or other possible confounders.

“The steps per day–diabetes association was not modified by age, race/ethnicity, BMI, physical functioning, or family history of diabetes, which supports the generalizability of these findings to community-living older women,” the investigators wrote.

Increased stepping intensity also appeared to lower risk of diabetes. After adjusting for confounding variables, light stepping was not linked to reduced risk (HR, 0.97; 95% CI, 0.73-1.29; P = .83), whereas moderate to vigorous stepping reduced risk by 14% per 2,000 steps (HR, 0.86; 95% CI, 0.74-1.00; P = .04).

“This study provides evidence supporting an association between steps per day and lower incident diabetes,” the investigators concluded. “While further work is needed to identify whether there is a minimum number of steps per day that results in a clinically significant reduction of diabetes and to evaluate the role that step intensity plays in diabetes etiology for older adults, findings from this study suggest that moderate-vigorous–intensity steps may be more important than lower-intensity steps with respect to incident diabetes. Steps per day–based interventions are needed to advance diabetes prevention science in older adults.”

The study was supported by the National Institute on Aging, the National Institute of Diabetes and Digestive and Kidney Diseases, the Tobacco-Related Disease Research Program, and others. The investigators had no potential conflicts of interest.

More steps per day, particularly at a higher intensity, may reduce the risk of type 2 diabetes in older women, based on a prospective cohort study.

The link between daily stepping and diabetes was not significantly modified by body mass index (BMI) or other common diabetes risk factors, suggesting that the relationship is highly generalizable, lead author Alexis C. Garduno, MPH, a PhD student at the University of California, San Diego, and colleagues reported.

“Physical activity is a key modifiable behavior for diabetes prevention and management,” the investigators wrote in Diabetes Care. “Many prevention studies have demonstrated that regular physical activity, along with improved diet, reduces the risk of diabetes in adults. ... To the best of our knowledge, there are few studies examining the association between objectively measured steps per day and incident diabetes in a community-based setting.”

To this end, the investigators analyzed data from 4,838 older, community-living women in the Objective Physical Activity and Cardiovascular Health Study. Upon enrollment, women were without physician-diagnosed diabetes and had a mean age of 78.9 years. For 1 week, participants wore ActiGraph GT3X+ accelerometers to measure steps per day, as well as step intensity, graded as light or moderate to vigorous.

The relationship between daily activity and diabetes was analyzed using three multivariate models: The first included race/ethnicity and age; the second also included family history of diabetes, education, physical functioning, self-rated health, smoking status, and alcohol consumption; and the third added BMI, “a potential mediator in the causal pathway between steps per day and diabetes,” the investigators wrote.

Participants took an average of 3,729 steps per day, divided roughly evenly between light and moderate to vigorous intensity.

After a median follow-up of 5.7 years, 8.1% of women developed diabetes. The least-adjusted model showed a 14% reduction in diabetes risk per 2,000 steps (hazard ratio, 0.86; 95% confidence interval, 0.80-0.92; P = .007), whereas the second model, adjusting for more confounding variables, showed a 12% reduction in diabetes risk per 2,000 steps (HR, 0.88; 95% CI, 0.78-1.00; P = .045).

The final model, which added BMI, showed a 10% reduction in risk, although it didn’t reach statistical significance (HR, 0.90; 95% CI, 0.80-1.02; P = .11). Furthermore, accelerated failure time models suggested that BMI did not significantly impact the link between steps and diabetes (proportion mediated, 17.7%;95% CI, –55.0 to 142.0; P = .09). Further analyses also found no significant interactions between BMI or other possible confounders.

“The steps per day–diabetes association was not modified by age, race/ethnicity, BMI, physical functioning, or family history of diabetes, which supports the generalizability of these findings to community-living older women,” the investigators wrote.

Increased stepping intensity also appeared to lower risk of diabetes. After adjusting for confounding variables, light stepping was not linked to reduced risk (HR, 0.97; 95% CI, 0.73-1.29; P = .83), whereas moderate to vigorous stepping reduced risk by 14% per 2,000 steps (HR, 0.86; 95% CI, 0.74-1.00; P = .04).

“This study provides evidence supporting an association between steps per day and lower incident diabetes,” the investigators concluded. “While further work is needed to identify whether there is a minimum number of steps per day that results in a clinically significant reduction of diabetes and to evaluate the role that step intensity plays in diabetes etiology for older adults, findings from this study suggest that moderate-vigorous–intensity steps may be more important than lower-intensity steps with respect to incident diabetes. Steps per day–based interventions are needed to advance diabetes prevention science in older adults.”

The study was supported by the National Institute on Aging, the National Institute of Diabetes and Digestive and Kidney Diseases, the Tobacco-Related Disease Research Program, and others. The investigators had no potential conflicts of interest.

More steps per day, particularly at a higher intensity, may reduce the risk of type 2 diabetes in older women, based on a prospective cohort study.

The link between daily stepping and diabetes was not significantly modified by body mass index (BMI) or other common diabetes risk factors, suggesting that the relationship is highly generalizable, lead author Alexis C. Garduno, MPH, a PhD student at the University of California, San Diego, and colleagues reported.

“Physical activity is a key modifiable behavior for diabetes prevention and management,” the investigators wrote in Diabetes Care. “Many prevention studies have demonstrated that regular physical activity, along with improved diet, reduces the risk of diabetes in adults. ... To the best of our knowledge, there are few studies examining the association between objectively measured steps per day and incident diabetes in a community-based setting.”

To this end, the investigators analyzed data from 4,838 older, community-living women in the Objective Physical Activity and Cardiovascular Health Study. Upon enrollment, women were without physician-diagnosed diabetes and had a mean age of 78.9 years. For 1 week, participants wore ActiGraph GT3X+ accelerometers to measure steps per day, as well as step intensity, graded as light or moderate to vigorous.

The relationship between daily activity and diabetes was analyzed using three multivariate models: The first included race/ethnicity and age; the second also included family history of diabetes, education, physical functioning, self-rated health, smoking status, and alcohol consumption; and the third added BMI, “a potential mediator in the causal pathway between steps per day and diabetes,” the investigators wrote.

Participants took an average of 3,729 steps per day, divided roughly evenly between light and moderate to vigorous intensity.

After a median follow-up of 5.7 years, 8.1% of women developed diabetes. The least-adjusted model showed a 14% reduction in diabetes risk per 2,000 steps (hazard ratio, 0.86; 95% confidence interval, 0.80-0.92; P = .007), whereas the second model, adjusting for more confounding variables, showed a 12% reduction in diabetes risk per 2,000 steps (HR, 0.88; 95% CI, 0.78-1.00; P = .045).

The final model, which added BMI, showed a 10% reduction in risk, although it didn’t reach statistical significance (HR, 0.90; 95% CI, 0.80-1.02; P = .11). Furthermore, accelerated failure time models suggested that BMI did not significantly impact the link between steps and diabetes (proportion mediated, 17.7%;95% CI, –55.0 to 142.0; P = .09). Further analyses also found no significant interactions between BMI or other possible confounders.

“The steps per day–diabetes association was not modified by age, race/ethnicity, BMI, physical functioning, or family history of diabetes, which supports the generalizability of these findings to community-living older women,” the investigators wrote.

Increased stepping intensity also appeared to lower risk of diabetes. After adjusting for confounding variables, light stepping was not linked to reduced risk (HR, 0.97; 95% CI, 0.73-1.29; P = .83), whereas moderate to vigorous stepping reduced risk by 14% per 2,000 steps (HR, 0.86; 95% CI, 0.74-1.00; P = .04).

“This study provides evidence supporting an association between steps per day and lower incident diabetes,” the investigators concluded. “While further work is needed to identify whether there is a minimum number of steps per day that results in a clinically significant reduction of diabetes and to evaluate the role that step intensity plays in diabetes etiology for older adults, findings from this study suggest that moderate-vigorous–intensity steps may be more important than lower-intensity steps with respect to incident diabetes. Steps per day–based interventions are needed to advance diabetes prevention science in older adults.”

The study was supported by the National Institute on Aging, the National Institute of Diabetes and Digestive and Kidney Diseases, the Tobacco-Related Disease Research Program, and others. The investigators had no potential conflicts of interest.

Over the period of 1 year, secukinumab 300 mg every 2 weeks demonstrated superior efficacy compared with secukinumab 300 mg every 4 weeks in overweight patients with moderate to severe plaque psoriasis, results from a multicenter, double-blind, parallel-group trial showed.

The more frequent dosing was also associated with comparable safety, consistent with the established secukinumab safety profile.

“Weight may have an impact on pharmacokinetics and, therefore, on the clinical outcome of biologic treatment for psoriasis,” Matthias Augustin, MD, and colleagues wrote in the study, published recently in the British Journal of Dermatology. “Dose optimization may be highly beneficial for patients with higher body weight,” they noted, adding that their study supports previous study findings and pharmacokinetic/pharmacodynamic modelling data, showing that secukinumab dosed every 2 weeks “leads to a clinically and statistically significant advantage in PASI 90 response,” compared with standard dosing every 4 weeks in patients who weight 90 kg (about 198 pounds) or more, after 16 weeks of treatment, which was maintained until week 52.

For the study, Dr. Augustin, of the Institute for Health Services Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 331 patients with moderate to severe chronic plaque psoriasis who weighed 90 kg or more to receive secukinumab 300 mg every 2 weeks, or secukinumab 300 mg every 4 weeks. The mean age of the patients was 47 years, 75% were male, 92% were White, and their mean body weight was 111.1 kg, with a mean body mass index of 36.1 kg/m².

Patients who did not achieve a Psoriasis Area and Severity Index (PASI) 90 at week 16 on the monthly regimen (Q4W) either remained on that regimen or were up-titrated to dosing every 2 weeks (Q2W). Of the 331 patients, 165 received Q2W dosing and 166 received Q4W dosing. The researchers found that, at 16 weeks, patients in the Q2W dosing group had significantly higher PASI 90 responses, compared with those in the Q4W group (73.2% vs. 55.5%, respectively; P = .0003; odds ratio estimate, 2.3).

At 52 weeks, a greater proportion of patients in the Q2W group maintained responses to several outcome measures, compared with those in the Q4W group, including PASI 75 (88.9% vs. 74.8%), PASI 90 (76.4% vs. 52.4%), and PASI 100 (46.7% vs. 27.3%) scores; Investigator’s Global Assessment score of 0 or 1 (75.9% vs. 55.6%); and Dermatology Life Quality Index scores of 0 or 1 (66.1% vs. 48.8%).

In addition, those who had not had a PASI 90 response at week 16 who were up-titrated to Q2W dosing demonstrated higher efficacy responses at week 32, compared with those who remained on the Q4W regimen, with PASI 90 scores of 37.7% versus 16.5%, respectively.

Both regimens were well-tolerated, consistent with the known secukinumab safety profile; safety was comparable in the treatment arms, and there was “no clear dose-response relationship seen” for the incidence of overall adverse events, serious AEs, and AEs leading to discontinuation of the study treatment, “or AEs related to the identified risks” of infections, hypersensitivity, neutropenia and potential risk of major adverse cardiovascular events, the authors wrote.

“Despite more frequent dosing, the incidence of Candida infections was numerically lower in the Q2W group versus the Q4W group,” although there were not many cases, three patients versus six patients, respectively.

 

Need for individualized treatment

“Despite a decades-long revolution in development of highly efficacious biologic treatments for psoriasis, we are only in the early stages of developing personalized clinical approaches,” said Raj Chovatiya, MD, PhD, a dermatologist at Northwestern University, Chicago, who was asked to comment on the study. “The need for individualized treatment in psoriasis is very real; not every patient may respond to therapy in the same way. Obesity is one important comorbidity of psoriasis, and increased body mass index may be associated with variable treatment outcomes with systemic therapy.”

The data from this study, he added, “suggest that dose optimization may be an important strategy to enhance psoriasis clearance in patients with suboptimal treatment outcomes on standard dosing, including those with increased weight. Future studies should examine optimal regimen of biologic therapy across a variety of patient factors.”

The study was funded by Novartis, the manufacturer of secukinumab (Cosentyx); several authors were company employees. Dr. Augustin disclosed that he has served as a consultant for or has been a paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB, and Xenoport. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

Over the period of 1 year, secukinumab 300 mg every 2 weeks demonstrated superior efficacy compared with secukinumab 300 mg every 4 weeks in overweight patients with moderate to severe plaque psoriasis, results from a multicenter, double-blind, parallel-group trial showed.

The more frequent dosing was also associated with comparable safety, consistent with the established secukinumab safety profile.

“Weight may have an impact on pharmacokinetics and, therefore, on the clinical outcome of biologic treatment for psoriasis,” Matthias Augustin, MD, and colleagues wrote in the study, published recently in the British Journal of Dermatology. “Dose optimization may be highly beneficial for patients with higher body weight,” they noted, adding that their study supports previous study findings and pharmacokinetic/pharmacodynamic modelling data, showing that secukinumab dosed every 2 weeks “leads to a clinically and statistically significant advantage in PASI 90 response,” compared with standard dosing every 4 weeks in patients who weight 90 kg (about 198 pounds) or more, after 16 weeks of treatment, which was maintained until week 52.

For the study, Dr. Augustin, of the Institute for Health Services Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 331 patients with moderate to severe chronic plaque psoriasis who weighed 90 kg or more to receive secukinumab 300 mg every 2 weeks, or secukinumab 300 mg every 4 weeks. The mean age of the patients was 47 years, 75% were male, 92% were White, and their mean body weight was 111.1 kg, with a mean body mass index of 36.1 kg/m².

Patients who did not achieve a Psoriasis Area and Severity Index (PASI) 90 at week 16 on the monthly regimen (Q4W) either remained on that regimen or were up-titrated to dosing every 2 weeks (Q2W). Of the 331 patients, 165 received Q2W dosing and 166 received Q4W dosing. The researchers found that, at 16 weeks, patients in the Q2W dosing group had significantly higher PASI 90 responses, compared with those in the Q4W group (73.2% vs. 55.5%, respectively; P = .0003; odds ratio estimate, 2.3).

At 52 weeks, a greater proportion of patients in the Q2W group maintained responses to several outcome measures, compared with those in the Q4W group, including PASI 75 (88.9% vs. 74.8%), PASI 90 (76.4% vs. 52.4%), and PASI 100 (46.7% vs. 27.3%) scores; Investigator’s Global Assessment score of 0 or 1 (75.9% vs. 55.6%); and Dermatology Life Quality Index scores of 0 or 1 (66.1% vs. 48.8%).

In addition, those who had not had a PASI 90 response at week 16 who were up-titrated to Q2W dosing demonstrated higher efficacy responses at week 32, compared with those who remained on the Q4W regimen, with PASI 90 scores of 37.7% versus 16.5%, respectively.

Both regimens were well-tolerated, consistent with the known secukinumab safety profile; safety was comparable in the treatment arms, and there was “no clear dose-response relationship seen” for the incidence of overall adverse events, serious AEs, and AEs leading to discontinuation of the study treatment, “or AEs related to the identified risks” of infections, hypersensitivity, neutropenia and potential risk of major adverse cardiovascular events, the authors wrote.

“Despite more frequent dosing, the incidence of Candida infections was numerically lower in the Q2W group versus the Q4W group,” although there were not many cases, three patients versus six patients, respectively.

 

Need for individualized treatment

“Despite a decades-long revolution in development of highly efficacious biologic treatments for psoriasis, we are only in the early stages of developing personalized clinical approaches,” said Raj Chovatiya, MD, PhD, a dermatologist at Northwestern University, Chicago, who was asked to comment on the study. “The need for individualized treatment in psoriasis is very real; not every patient may respond to therapy in the same way. Obesity is one important comorbidity of psoriasis, and increased body mass index may be associated with variable treatment outcomes with systemic therapy.”

The data from this study, he added, “suggest that dose optimization may be an important strategy to enhance psoriasis clearance in patients with suboptimal treatment outcomes on standard dosing, including those with increased weight. Future studies should examine optimal regimen of biologic therapy across a variety of patient factors.”

The study was funded by Novartis, the manufacturer of secukinumab (Cosentyx); several authors were company employees. Dr. Augustin disclosed that he has served as a consultant for or has been a paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB, and Xenoport. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

Over the period of 1 year, secukinumab 300 mg every 2 weeks demonstrated superior efficacy compared with secukinumab 300 mg every 4 weeks in overweight patients with moderate to severe plaque psoriasis, results from a multicenter, double-blind, parallel-group trial showed.

The more frequent dosing was also associated with comparable safety, consistent with the established secukinumab safety profile.

“Weight may have an impact on pharmacokinetics and, therefore, on the clinical outcome of biologic treatment for psoriasis,” Matthias Augustin, MD, and colleagues wrote in the study, published recently in the British Journal of Dermatology. “Dose optimization may be highly beneficial for patients with higher body weight,” they noted, adding that their study supports previous study findings and pharmacokinetic/pharmacodynamic modelling data, showing that secukinumab dosed every 2 weeks “leads to a clinically and statistically significant advantage in PASI 90 response,” compared with standard dosing every 4 weeks in patients who weight 90 kg (about 198 pounds) or more, after 16 weeks of treatment, which was maintained until week 52.

For the study, Dr. Augustin, of the Institute for Health Services Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany), and colleagues randomized 331 patients with moderate to severe chronic plaque psoriasis who weighed 90 kg or more to receive secukinumab 300 mg every 2 weeks, or secukinumab 300 mg every 4 weeks. The mean age of the patients was 47 years, 75% were male, 92% were White, and their mean body weight was 111.1 kg, with a mean body mass index of 36.1 kg/m².

Patients who did not achieve a Psoriasis Area and Severity Index (PASI) 90 at week 16 on the monthly regimen (Q4W) either remained on that regimen or were up-titrated to dosing every 2 weeks (Q2W). Of the 331 patients, 165 received Q2W dosing and 166 received Q4W dosing. The researchers found that, at 16 weeks, patients in the Q2W dosing group had significantly higher PASI 90 responses, compared with those in the Q4W group (73.2% vs. 55.5%, respectively; P = .0003; odds ratio estimate, 2.3).

At 52 weeks, a greater proportion of patients in the Q2W group maintained responses to several outcome measures, compared with those in the Q4W group, including PASI 75 (88.9% vs. 74.8%), PASI 90 (76.4% vs. 52.4%), and PASI 100 (46.7% vs. 27.3%) scores; Investigator’s Global Assessment score of 0 or 1 (75.9% vs. 55.6%); and Dermatology Life Quality Index scores of 0 or 1 (66.1% vs. 48.8%).

In addition, those who had not had a PASI 90 response at week 16 who were up-titrated to Q2W dosing demonstrated higher efficacy responses at week 32, compared with those who remained on the Q4W regimen, with PASI 90 scores of 37.7% versus 16.5%, respectively.

Both regimens were well-tolerated, consistent with the known secukinumab safety profile; safety was comparable in the treatment arms, and there was “no clear dose-response relationship seen” for the incidence of overall adverse events, serious AEs, and AEs leading to discontinuation of the study treatment, “or AEs related to the identified risks” of infections, hypersensitivity, neutropenia and potential risk of major adverse cardiovascular events, the authors wrote.

“Despite more frequent dosing, the incidence of Candida infections was numerically lower in the Q2W group versus the Q4W group,” although there were not many cases, three patients versus six patients, respectively.

 

Need for individualized treatment

“Despite a decades-long revolution in development of highly efficacious biologic treatments for psoriasis, we are only in the early stages of developing personalized clinical approaches,” said Raj Chovatiya, MD, PhD, a dermatologist at Northwestern University, Chicago, who was asked to comment on the study. “The need for individualized treatment in psoriasis is very real; not every patient may respond to therapy in the same way. Obesity is one important comorbidity of psoriasis, and increased body mass index may be associated with variable treatment outcomes with systemic therapy.”

The data from this study, he added, “suggest that dose optimization may be an important strategy to enhance psoriasis clearance in patients with suboptimal treatment outcomes on standard dosing, including those with increased weight. Future studies should examine optimal regimen of biologic therapy across a variety of patient factors.”

The study was funded by Novartis, the manufacturer of secukinumab (Cosentyx); several authors were company employees. Dr. Augustin disclosed that he has served as a consultant for or has been a paid speaker for clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Almirall, Amgen, Biogen, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Medac, Merck, MSD, Novartis, Pfizer, UCB, and Xenoport. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arcutis, Arena, Incyte, Pfizer, Regeneron, and Sanofi Genzyme.

Dietary guidelines provide scientifically sound and practical advice that, if followed by every person, would probably result in less obesity, type 2 diabetes, cardiovascular disease, cancer, and bone loss. But few US adults meet these recommendations, according to a recent report in the CDC’s Morbidity and Mortality Weekly Report (MMWR).¹

Data from the 2019 Behavioral Risk Factor Surveillance system indicate that only 12.3% of US adults consumed the recommended amount of fruit and 10% the recommended amount of vegetables (more on that shortly). Women were more likely than men to meet the requirements for fruit (14.5% vs 10.1%) and vegetable (12.4% vs 7.6%) intake. The vegetable recommendation was more likely to be met by those in higher income households than those in the lowest income categories (12.2% vs 6.8%).¹

Just what’s recommended? The most recent dietary guidelines from the Department of Agriculture suggest that adults should consume 1.5 to 2 cup-equivalents of fruits and 2 to 3 cup-equivalents of vegetables each day.² What is a cup-equivalent? Examples include: 1 cup of a raw, or cooked, vegetable or fruit; 1 cup of fruit juice; 2 cups of leafy salad greens; or 1/2 cup of a dried fruit or vegetable. Additional recommendations are that added sugar constitute < 10% of calories per day, saturated fat < 10% of calories per day, and sodium < 2300 mg per day.

Simplify the message to this … There’s an easy message for clinicians to provide to patients: Consume 2 cups of fruit and 2 to 3 cups of vegetables per day; increase intake of whole grains, seafood, nuts, and seeds; choose fat-free and low-fat dairy products; and avoid sugary beverages and foods. But as we know, recommending that patients do something and actually having them do it are often 2 different things. So how can we tip the scales in a healthier direction?

Advise patients not to go it alone. The US Preventive Services Task Force recommends intensive behavioral interventions to alter eating habits. These interventions include individual or group counseling sessions over extended periods (eg, 6 hours of contact time over 6 to 18 months), including some 1-on-1 time with a specially trained professional, such as a primary care physician, nurse, registered dietitian, or nutritionist. The good news is that, for those with cardiovascular risk factors (dyslipidemia, elevated blood pressure, type 2 diabetes, and hypertension), this is a level “B” recommendation—meaning these interventions should be covered by commercial health insurance with no out-of-pocket cost to patients.³

Dietary guidelines provide scientifically sound and practical advice that, if followed by every person, would probably result in less obesity, type 2 diabetes, cardiovascular disease, cancer, and bone loss. But few US adults meet these recommendations, according to a recent report in the CDC’s Morbidity and Mortality Weekly Report (MMWR).¹

Data from the 2019 Behavioral Risk Factor Surveillance system indicate that only 12.3% of US adults consumed the recommended amount of fruit and 10% the recommended amount of vegetables (more on that shortly). Women were more likely than men to meet the requirements for fruit (14.5% vs 10.1%) and vegetable (12.4% vs 7.6%) intake. The vegetable recommendation was more likely to be met by those in higher income households than those in the lowest income categories (12.2% vs 6.8%).¹

Just what’s recommended? The most recent dietary guidelines from the Department of Agriculture suggest that adults should consume 1.5 to 2 cup-equivalents of fruits and 2 to 3 cup-equivalents of vegetables each day.² What is a cup-equivalent? Examples include: 1 cup of a raw, or cooked, vegetable or fruit; 1 cup of fruit juice; 2 cups of leafy salad greens; or 1/2 cup of a dried fruit or vegetable. Additional recommendations are that added sugar constitute < 10% of calories per day, saturated fat < 10% of calories per day, and sodium < 2300 mg per day.

Simplify the message to this … There’s an easy message for clinicians to provide to patients: Consume 2 cups of fruit and 2 to 3 cups of vegetables per day; increase intake of whole grains, seafood, nuts, and seeds; choose fat-free and low-fat dairy products; and avoid sugary beverages and foods. But as we know, recommending that patients do something and actually having them do it are often 2 different things. So how can we tip the scales in a healthier direction?

Advise patients not to go it alone. The US Preventive Services Task Force recommends intensive behavioral interventions to alter eating habits. These interventions include individual or group counseling sessions over extended periods (eg, 6 hours of contact time over 6 to 18 months), including some 1-on-1 time with a specially trained professional, such as a primary care physician, nurse, registered dietitian, or nutritionist. The good news is that, for those with cardiovascular risk factors (dyslipidemia, elevated blood pressure, type 2 diabetes, and hypertension), this is a level “B” recommendation—meaning these interventions should be covered by commercial health insurance with no out-of-pocket cost to patients.³

Dietary guidelines provide scientifically sound and practical advice that, if followed by every person, would probably result in less obesity, type 2 diabetes, cardiovascular disease, cancer, and bone loss. But few US adults meet these recommendations, according to a recent report in the CDC’s Morbidity and Mortality Weekly Report (MMWR).¹

Data from the 2019 Behavioral Risk Factor Surveillance system indicate that only 12.3% of US adults consumed the recommended amount of fruit and 10% the recommended amount of vegetables (more on that shortly). Women were more likely than men to meet the requirements for fruit (14.5% vs 10.1%) and vegetable (12.4% vs 7.6%) intake. The vegetable recommendation was more likely to be met by those in higher income households than those in the lowest income categories (12.2% vs 6.8%).¹

Just what’s recommended? The most recent dietary guidelines from the Department of Agriculture suggest that adults should consume 1.5 to 2 cup-equivalents of fruits and 2 to 3 cup-equivalents of vegetables each day.² What is a cup-equivalent? Examples include: 1 cup of a raw, or cooked, vegetable or fruit; 1 cup of fruit juice; 2 cups of leafy salad greens; or 1/2 cup of a dried fruit or vegetable. Additional recommendations are that added sugar constitute < 10% of calories per day, saturated fat < 10% of calories per day, and sodium < 2300 mg per day.

Simplify the message to this … There’s an easy message for clinicians to provide to patients: Consume 2 cups of fruit and 2 to 3 cups of vegetables per day; increase intake of whole grains, seafood, nuts, and seeds; choose fat-free and low-fat dairy products; and avoid sugary beverages and foods. But as we know, recommending that patients do something and actually having them do it are often 2 different things. So how can we tip the scales in a healthier direction?

Advise patients not to go it alone. The US Preventive Services Task Force recommends intensive behavioral interventions to alter eating habits. These interventions include individual or group counseling sessions over extended periods (eg, 6 hours of contact time over 6 to 18 months), including some 1-on-1 time with a specially trained professional, such as a primary care physician, nurse, registered dietitian, or nutritionist. The good news is that, for those with cardiovascular risk factors (dyslipidemia, elevated blood pressure, type 2 diabetes, and hypertension), this is a level “B” recommendation—meaning these interventions should be covered by commercial health insurance with no out-of-pocket cost to patients.³

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

An intensive weight-loss intervention prior to conception had no effect on birth rates in women with obesity and unexplained infertility, compared with a standard weight-maintenance program, based on data from nearly 400 women.

Obese women experiencing infertility are often counseled to lose weight before attempting fertility treatments in order to improve outcomes based on epidemiologic evidence of an association between obesity and infertility, but data to support this advice are limited, wrote Richard S. Legro, MD, of Penn State University, Hershey, and colleagues.

The researchers proposed that a more intensive preconception weight loss intervention followed by infertility treatment would be more likely to yield a healthy live birth, compared with a standard weight maintenance intervention.

In an open-label study published in PLOS Medicine, the researchers randomized 379 women at nine academic centers to a standard lifestyle group that followed a weight-maintenance plan focused on physical activity, but not weight loss; or an intensive intervention of diet and medication with a target weight loss of 7%. Both interventions lasted for 16 weeks between July 2015 and July 2018. After the interventions, patients in both groups underwent standardized empiric fertility treatment with three cycles of ovarian stimulation and intrauterine insemination.

The primary outcome was a live birth at 37 weeks’ gestation or later, with no congenital abnormalities and a birth weight between 2,500 g and 4,000 g. Baseline characteristics including age, education level, race, and body mass index (BMI) were similar between the groups.

The incidence of healthy live births was not significantly different between the standard treatment and intensive treatment groups (15.2% vs. 12.2%; P = 0.40) by the final follow-up time of September 2019. However, women in the intensive group had significantly greater weight loss, compared with the standard group (–6.6% vs. –0.3%; P < .001). Women in the intensive group also showed improvements in metabolic health. Notably, the incidence of metabolic syndrome dropped from 53.6% to 49.4% in the standard group, compared with a decrease from 52.8% to 32.2% in the intensive group over the 16-week study period, the researchers wrote.

Gastrointestinal side effects were significantly more common in the intensive group, but these were consistent with documented side effects of the weight loss medication used (Orlistat).

First-trimester pregnancy loss was higher in the intensive group, compared with the standard group (33.3% vs. 23.7%), but the difference was not significant. Most pregnancy complications, including preterm labor, premature rupture of membranes, preeclampsia, and gestational diabetes had nonsignificant improvements in the intensive group, compared with the standard group. Similarly, nonsignificant improvements were noted in the intervention group for intrauterine growth restriction and admission to the neonatal ICU.

Limitations of the study included the relatively small number of pregnancies, which prevented assessment of rare complications in subgroups, and the challenge of matching control interventions, the researchers noted.

However, the results were strengthened by the focus on women with unexplained infertility, the inclusion of a comparison group, and the collection of data on complications after conception, they wrote.

Avenues for future research include interventions of different duration and intensity prior to conception, which may improve outcomes, the researchers said in their discussion of the findings. “A period of weight stabilization and maintenance after a weight-loss intervention prior to commencing infertility therapy is worth exploring,” they noted, but couples eager to conceive may be reluctant to wait for a weight-loss intervention, they added.

“Our findings directly impact current standards of clinical care, where women who are obese with unexplained infertility are to our knowledge routinely counseled to lose weight prior to initiation of infertility treatment,” they concluded.
 

Data may inform patient discussions

The current study is important because a large amount of previous research has shown an association between obesity and decreased fecundity in women and men, Mark P. Trolice, MD, of the University of Central Florida, Orlando, and director of the IVF Center in Winter Park, Fla., said in an interview.

According to the Centers for Disease Control and Prevention, the prevalence of obesity in the United States remains more than 40%, said Dr. Trolice. “Patients and physicians would benefit from clarity of obesity’s effect, if any, on reproduction,” he noted.

In contrast to the authors’ hypothesis, “the study did not find a difference in the live birth rate following up to three cycles of intrauterine insemination (IUI) between an intensive weight loss group [and] women who exercised without weight loss,” said Dr. Trolice. “Prior to this study, many reports suggested a decline in fertility with elevations in BMI, particularly during fertility treatment,” he added.

The take-home message from the current study is a that an elevated BMI, while possibly increasing the risks of metabolic disorders, did not appear to impact fecundity, he said.

The authors therefore concluded, “There is not strong evidence to recommend weight loss prior to conception in women who are obese with unexplained infertility,” Dr. Trolice said.

Regardless of the potential effect of preconception weight loss on fertility, barriers to starting a weight loss program include a woman’s eagerness to move forward with fertility treatments without waiting for weight loss, Dr. Trolice noted. “By the time a woman reaches an infertility specialist, she has been trying to conceive for at least 1 year,” he said. “At the initial consultation, these patients are anxious to undergo necessary additional diagnostic testing followed by treatment. Consequently, initiation of a weight-loss program is viewed as a delay toward the goal of family building,” he explained.

“More research is needed to demonstrate the safety of intensive weight loss preconception,” said Dr. Trolice. However, he said, “the issue of elevated BMI and increased risk of pregnancy complications remains, but this study provides important information for providers regarding counseling their patients desiring pregnancy.”

The study was supported by multiple grants from the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Center for Advancing Translational Sciences. Nutrisystem provided discounted coupons for food allotments in the standardized treatment group, and FitBit provided the study organizers with discounted Fitbits for activity monitoring. Lead author Dr. Legro disclosed consulting fees from InSupp, Ferring, Bayer, Abbvie and Fractyl, and research sponsorship from Guerbet and the National Institutes of Health. Dr. Trolice had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn News.

A study showing that once-weekly subcutaneous semaglutide 2.4 mg (Wegovy, Novo Nordisk) produces greater long-term weight loss than once-daily injected liraglutide 3.0 mg (Saxenda, Novo Nordisk) among adults with overweight or obesity without diabetes has now been published.

The data, previously reported at Obesity Week 2021, were published online Jan. 11 in JAMA.

The findings are from the phase 3 Semaglutide Treatment Effect in People with Obesity (STEP) 8 trial by Domenica M. Rubino, MD, of the Washington Center for Weight Management and Research, Arlington, Virginia, and colleagues.

Semaglutide and liraglutide, subcutaneously injectable glucagon-like peptide-1 (GLP-1) agonists, were both first approved for the treatment of type 2 diabetes in the United States and elsewhere, but are now also approved, in different doses, for chronic weight management and in people with obesity or overweight and comorbidities. A phase 2 trial demonstrated that once-daily semaglutide 0.4 mg produced significantly more weight loss than liraglutide 3.0 mg.

“Semaglutide and liraglutide induce weight loss by lowering energy intake. However, the reduction in caloric intake versus placebo appears to be larger with semaglutide (35%) than liraglutide (approximately 16%),” say Dr. Rubino and colleagues.

“Semaglutide has also been associated with reductions in food cravings, which is less evident with liraglutide, suggesting different mechanisms of energy intake regulation,” they add.   

Novo Nordisk has recently reported that there may be supply problems with Wegovy, as a contract manufacturer that fills syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues related to good manufacturing practice.

The company is also developing an oral form of semaglutide for weight loss. The oral form has already been approved in doses of 7 or 14 mg/day for the treatment of type 2 diabetes in the United States as Rybelsus.

Individualize treatment for those with obesity

STEP 8 was a randomized, open-label, 68-week phase 3b trial of 338 adults randomized to once-weekly semaglutide 2.4 mg (n = 126), once-daily liraglutide 3.0 mg (n = 127), or matched injected placebo (n = 85) for 68 weeks, all provided with counseling on diet and physical activity.  

The primary outcome – estimated mean change in body weight at week 68 – was –15.8% with semaglutide versus –6.4% with liraglutide, a significant difference (P < .001). The proportions of patients achieving loss of body weight of 10%, 15%, or 20% were 70.9%, 55.6%, and 38.5% with semaglutide versus 25.6%, 12.0%, and 6.0% with liraglutide, respectively.

Significantly greater reductions were also seen at 68 weeks for weekly semaglutide versus daily liraglutide in absolute body weight, waist circumference, diastolic blood pressure, total cholesterol, very low-density cholesterol, triglycerides, A1c, fasting plasma glucose, and C-reactive protein. Differences in systolic blood pressure, LDL and HDL cholesterol, free fatty acids, and fasting serum insulin did not achieve significance.

Overall, 19.8% of patients permanently discontinued treatment, with the most discontinuations in the liraglutide group (27.6%), followed by placebo (17.6%) and semaglutide (3.5%). Time to first and permanent discontinuation were shorter with liraglutide than with semaglutide or placebo.

Adverse events were reported by 95.2% of patients with semaglutide, 96.1% with liraglutide, and 95.3% with placebo. Gastrointestinal disorders were the most common with the two active drugs, reported by 84.1% with semaglutide and 82.7% with liraglutide versus 55.3% with placebo.

Most side effects were mild to moderate and resolved without treatment discontinuation. Severe gastrointestinal adverse events were reported by only 3.2%, 2.4%, and 3.5% of patients with semaglutide, liraglutide, and placebo, respectively.

“This trial found weight loss with semaglutide was significantly greater than with liraglutide. However, the variability in treatment response means an individual’s tolerance and sensitivity to a specific treatment is important for obesity management,” the researchers observe.

“Therefore, having multiple antiobesity medications proven to lower body weight through different mechanisms, with different adverse effect profiles and dosing regimens, can only benefit clinicians and patients,” they conclude.

The trial was funded by Novo Nordisk. Dr. Rubino has reported being a clinical investigator for Boehringer Ingelheim, AstraZeneca, and Novo Nordisk; receiving honoraria from WebMD; receiving speaker fees, consulting fees, scientific advisory fees, and honoraria from Novo Nordisk; receiving grants from SARL and personal fees from Medscape, PeerView, and the Endocrine Society; and being a shareholder in Novo Nordisk.

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

A study showing that once-weekly subcutaneous semaglutide 2.4 mg (Wegovy, Novo Nordisk) produces greater long-term weight loss than once-daily injected liraglutide 3.0 mg (Saxenda, Novo Nordisk) among adults with overweight or obesity without diabetes has now been published.

The data, previously reported at Obesity Week 2021, were published online Jan. 11 in JAMA.

The findings are from the phase 3 Semaglutide Treatment Effect in People with Obesity (STEP) 8 trial by Domenica M. Rubino, MD, of the Washington Center for Weight Management and Research, Arlington, Virginia, and colleagues.

Semaglutide and liraglutide, subcutaneously injectable glucagon-like peptide-1 (GLP-1) agonists, were both first approved for the treatment of type 2 diabetes in the United States and elsewhere, but are now also approved, in different doses, for chronic weight management and in people with obesity or overweight and comorbidities. A phase 2 trial demonstrated that once-daily semaglutide 0.4 mg produced significantly more weight loss than liraglutide 3.0 mg.

“Semaglutide and liraglutide induce weight loss by lowering energy intake. However, the reduction in caloric intake versus placebo appears to be larger with semaglutide (35%) than liraglutide (approximately 16%),” say Dr. Rubino and colleagues.

“Semaglutide has also been associated with reductions in food cravings, which is less evident with liraglutide, suggesting different mechanisms of energy intake regulation,” they add.   

Novo Nordisk has recently reported that there may be supply problems with Wegovy, as a contract manufacturer that fills syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues related to good manufacturing practice.

The company is also developing an oral form of semaglutide for weight loss. The oral form has already been approved in doses of 7 or 14 mg/day for the treatment of type 2 diabetes in the United States as Rybelsus.

Individualize treatment for those with obesity

STEP 8 was a randomized, open-label, 68-week phase 3b trial of 338 adults randomized to once-weekly semaglutide 2.4 mg (n = 126), once-daily liraglutide 3.0 mg (n = 127), or matched injected placebo (n = 85) for 68 weeks, all provided with counseling on diet and physical activity.  

The primary outcome – estimated mean change in body weight at week 68 – was –15.8% with semaglutide versus –6.4% with liraglutide, a significant difference (P < .001). The proportions of patients achieving loss of body weight of 10%, 15%, or 20% were 70.9%, 55.6%, and 38.5% with semaglutide versus 25.6%, 12.0%, and 6.0% with liraglutide, respectively.

Significantly greater reductions were also seen at 68 weeks for weekly semaglutide versus daily liraglutide in absolute body weight, waist circumference, diastolic blood pressure, total cholesterol, very low-density cholesterol, triglycerides, A1c, fasting plasma glucose, and C-reactive protein. Differences in systolic blood pressure, LDL and HDL cholesterol, free fatty acids, and fasting serum insulin did not achieve significance.

Overall, 19.8% of patients permanently discontinued treatment, with the most discontinuations in the liraglutide group (27.6%), followed by placebo (17.6%) and semaglutide (3.5%). Time to first and permanent discontinuation were shorter with liraglutide than with semaglutide or placebo.

Adverse events were reported by 95.2% of patients with semaglutide, 96.1% with liraglutide, and 95.3% with placebo. Gastrointestinal disorders were the most common with the two active drugs, reported by 84.1% with semaglutide and 82.7% with liraglutide versus 55.3% with placebo.

Most side effects were mild to moderate and resolved without treatment discontinuation. Severe gastrointestinal adverse events were reported by only 3.2%, 2.4%, and 3.5% of patients with semaglutide, liraglutide, and placebo, respectively.

“This trial found weight loss with semaglutide was significantly greater than with liraglutide. However, the variability in treatment response means an individual’s tolerance and sensitivity to a specific treatment is important for obesity management,” the researchers observe.

“Therefore, having multiple antiobesity medications proven to lower body weight through different mechanisms, with different adverse effect profiles and dosing regimens, can only benefit clinicians and patients,” they conclude.

The trial was funded by Novo Nordisk. Dr. Rubino has reported being a clinical investigator for Boehringer Ingelheim, AstraZeneca, and Novo Nordisk; receiving honoraria from WebMD; receiving speaker fees, consulting fees, scientific advisory fees, and honoraria from Novo Nordisk; receiving grants from SARL and personal fees from Medscape, PeerView, and the Endocrine Society; and being a shareholder in Novo Nordisk.

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

A study showing that once-weekly subcutaneous semaglutide 2.4 mg (Wegovy, Novo Nordisk) produces greater long-term weight loss than once-daily injected liraglutide 3.0 mg (Saxenda, Novo Nordisk) among adults with overweight or obesity without diabetes has now been published.

The data, previously reported at Obesity Week 2021, were published online Jan. 11 in JAMA.

The findings are from the phase 3 Semaglutide Treatment Effect in People with Obesity (STEP) 8 trial by Domenica M. Rubino, MD, of the Washington Center for Weight Management and Research, Arlington, Virginia, and colleagues.

Semaglutide and liraglutide, subcutaneously injectable glucagon-like peptide-1 (GLP-1) agonists, were both first approved for the treatment of type 2 diabetes in the United States and elsewhere, but are now also approved, in different doses, for chronic weight management and in people with obesity or overweight and comorbidities. A phase 2 trial demonstrated that once-daily semaglutide 0.4 mg produced significantly more weight loss than liraglutide 3.0 mg.

“Semaglutide and liraglutide induce weight loss by lowering energy intake. However, the reduction in caloric intake versus placebo appears to be larger with semaglutide (35%) than liraglutide (approximately 16%),” say Dr. Rubino and colleagues.

“Semaglutide has also been associated with reductions in food cravings, which is less evident with liraglutide, suggesting different mechanisms of energy intake regulation,” they add.   

Novo Nordisk has recently reported that there may be supply problems with Wegovy, as a contract manufacturer that fills syringes for pens to inject the drug temporarily halted deliveries and manufacturing after issues related to good manufacturing practice.

The company is also developing an oral form of semaglutide for weight loss. The oral form has already been approved in doses of 7 or 14 mg/day for the treatment of type 2 diabetes in the United States as Rybelsus.

Individualize treatment for those with obesity

STEP 8 was a randomized, open-label, 68-week phase 3b trial of 338 adults randomized to once-weekly semaglutide 2.4 mg (n = 126), once-daily liraglutide 3.0 mg (n = 127), or matched injected placebo (n = 85) for 68 weeks, all provided with counseling on diet and physical activity.  

The primary outcome – estimated mean change in body weight at week 68 – was –15.8% with semaglutide versus –6.4% with liraglutide, a significant difference (P < .001). The proportions of patients achieving loss of body weight of 10%, 15%, or 20% were 70.9%, 55.6%, and 38.5% with semaglutide versus 25.6%, 12.0%, and 6.0% with liraglutide, respectively.

Significantly greater reductions were also seen at 68 weeks for weekly semaglutide versus daily liraglutide in absolute body weight, waist circumference, diastolic blood pressure, total cholesterol, very low-density cholesterol, triglycerides, A1c, fasting plasma glucose, and C-reactive protein. Differences in systolic blood pressure, LDL and HDL cholesterol, free fatty acids, and fasting serum insulin did not achieve significance.

Overall, 19.8% of patients permanently discontinued treatment, with the most discontinuations in the liraglutide group (27.6%), followed by placebo (17.6%) and semaglutide (3.5%). Time to first and permanent discontinuation were shorter with liraglutide than with semaglutide or placebo.

Adverse events were reported by 95.2% of patients with semaglutide, 96.1% with liraglutide, and 95.3% with placebo. Gastrointestinal disorders were the most common with the two active drugs, reported by 84.1% with semaglutide and 82.7% with liraglutide versus 55.3% with placebo.

Most side effects were mild to moderate and resolved without treatment discontinuation. Severe gastrointestinal adverse events were reported by only 3.2%, 2.4%, and 3.5% of patients with semaglutide, liraglutide, and placebo, respectively.

“This trial found weight loss with semaglutide was significantly greater than with liraglutide. However, the variability in treatment response means an individual’s tolerance and sensitivity to a specific treatment is important for obesity management,” the researchers observe.

“Therefore, having multiple antiobesity medications proven to lower body weight through different mechanisms, with different adverse effect profiles and dosing regimens, can only benefit clinicians and patients,” they conclude.

The trial was funded by Novo Nordisk. Dr. Rubino has reported being a clinical investigator for Boehringer Ingelheim, AstraZeneca, and Novo Nordisk; receiving honoraria from WebMD; receiving speaker fees, consulting fees, scientific advisory fees, and honoraria from Novo Nordisk; receiving grants from SARL and personal fees from Medscape, PeerView, and the Endocrine Society; and being a shareholder in Novo Nordisk.

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

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

A new study suggests that a healthy diet initiated by women before conception could lower the risk of obesity in the offspring.

Childhood obesity is a major public health concern in the United Kingdom, with nearly a quarter of children under 5 and more than a third of children starting secondary school being overweight or obese. Furthermore, childhood obesity is likely to persist in adulthood and have long-term health consequences.

Researchers at the University of Southampton (England) analyzed dietary data of 2,963 mother-child dyads identified from the U.K. Southampton Women’s Survey. Using the dietary data, each mother-child dyad was assigned combined diet quality score, based on which they were categorized into 5 groups: poor, poor-medium, medium, medium-better and best. Childhood adiposity was evaluated using dual-energy x-ray absorptiometry (DXA) and body mass index (BMI) z-scores.

The findings, published in the International Journal of Obesity, showed that mother-offspring diet quality trajectories were stable from preconception in mothers to age 8-9 years in the offspring. A poorer diet quality trajectory was linked to higher prepregnancy maternal BMI, lower maternal age at birth, lower educational levels, smoking, and multiparity. 

After adjusting for confounders, a 1-category reduction in the dietary trajectory was associated with higher DXA percentage body fat (standard deviation, 0.08; 95% confidence interval, 0.01-0.15) and BMI z-score (SD, 0.08; 95% CI, 0.00-0.16) in the offspring aged 8-9 years.

Lead author Sarah Crozier, PhD, University of Southampton, said: “This research shows the importance of intervening at the earliest possible stage in a child’s life, in pregnancy or even before conception, to enable us to tackle it.” The authors believe that the preconception period serves as a crucial window to introduce favorable changes in the maternal dietary quality.

The research was funded by grants from the Medical Research Council, Project EarlyNutrition, and the European Union’s Seventh Framework and Horizon 2020 programs. The study also received support from National Institute for Health Research Southampton Biomedical Research Centre, the University of Southampton and University Hospital Southampton NHS Foundation Trust. The authors reported no competing interests.

A version of this article first appeared on Medscape UK.

The Allurion intragastric balloon (formerly the Elipse, Allurion Technologies), a novel balloon that is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss and an improved metabolic profile, with fewer adverse events than reported with other available gastric balloons, results from a meta-analysis show.

“We believe this analysis to be the most comprehensive review [of the Allurion balloon],” reported first author Daryl Ramai, MD, of the division of gastroenterology and hepatology, University of Utah, Salt Lake City, and colleagues in the research, published in the November/December 2021 issue of the Journal of Clinical Gastroenterology.

“Our study showed that the Allurion balloon reduces waist circumference and triglyceride levels and [is] associated with less adverse events when compared with other intragastric balloons,” the authors concluded.

Unlike other balloons, the Allurion gastric balloon is compressed into a small capsule that is connected to a thin catheter and, once swallowed, it is then inflated with 550 mL of liquid through the catheter to create a feeling of fullness and help control hunger.

The procedure can be performed on an outpatient basis in approximately 20 minutes, potentially avoiding the burden and extra costs of surgery or endoscopic placement and removal. After approximately 4 months, the balloon is designed to empty through a valve that spontaneously opens, and the balloon is then passed in the stool.

Though currently used around the world, the balloon does not yet have approval from the Food and Drug Administration.
 

Meta-analysis shows 12.2% average weight loss across studies

To assess the balloon’s performance, the authors identified 7 out of 273 published studies that met the analysis criteria. The studies included 2,152 patients, ranging in age from 18 to 65 years, with a mean baseline body mass index of 32.1-38.6 kg/m2.

All of the studies were prospective, with reported outcomes at 3-4 months, when the Allurion balloon typically deflates. Three of the studies were multicenter, while four were single center.

In terms of improvements in BMI, the results showed the pooled mean difference from baseline through to the end of the studies was 0.88 (P = .001), and the weighted average percentage of total body weight loss during treatment across the studies was 12.2%.

The mean excess body weight loss across the Allurion studies was 49.1%.

The analysis was not designed to directly compare outcomes with other balloons, but the authors note, for instance, that the ReShape Duo intragastric balloon (an FDA-approved dual-balloon system) has been reported in a previous study to be associated with a percentage of total body weight loss of 7.6% at 6 months, compared with 3.6% observed among those with lifestyle modifications.

However, a separate meta-analysis showed the pooled percentage of total body weight loss with the FDA-approved Orbera balloon to be about the same as the current Allurion analysis, at 12.3% at 3 months after implantation (followed by 13.2% at 6 months and 11.3% at 12 months). The analysis further showed excess body weight loss with the Orbera balloon at 12 months to be 25.4%.

In other outcomes, the current meta-analysis also showed significant improvements with the Allurion balloon in waist circumference of 0.89 (P = .001) and in triglyceride levels of 0.66 (P = .004) versus baseline.

Previous research involving the FDA-approved Obalon intragastric balloon, which is inflated with gas rather than liquid, showed a significant reduction in waist circumference from 109 cm (±12.3) to 99 cm (±10.5) (P < .05), and another study showed that 37.5% of patients receiving the Orbera balloon had normalized triglyceride levels after 4 months, without concomitant medical therapy.
 

Adverse events appear lower vs. other balloons

Potential risks associated with the Allurion balloon include the potential for early deflation; however, the pooled rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.

Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%), and small bowel obstruction (0.5%).

The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons have been reported at 54.5% and 57.5%, respectively, with the effects possibly caused by overinflation, the authors noted.

And rates of vomiting with the ReShape Duo and Orbera balloons have been reported as much higher, at 86.7% and 86.8%, respectively.

Of note, there were no deaths or cases of acute pancreatitis reported in the meta-analysis studies of Allurion.

As reported by this news organization, such concerns have been raised in previous FDA alerts regarding the Orbera and ReShape Duo liquid-filled intragastric balloons.

In the most recent update, issued in April 2020, the FDA described receiving reports of 18 deaths that had occurred worldwide since the approvals of the Orbera and ReShape balloons, including eight in the United States.

Dr. Ramai noted that the concern about the issues is warranted.

“These concerns are valid,” he told this news organization. “Theoretically, since the Allurion balloon is placed for a shorter time span, it is conceivable that there may be less adverse events. However, comparative trials are needed to confirm this.”

Although the balloons show efficacy in patients struggling with weight loss, metabolic syndrome, and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Dr. Ramai said.

“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”

The study received no financial support. Dr. Ramai reported no relevant financial relationships.

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

The Allurion intragastric balloon (formerly the Elipse, Allurion Technologies), a novel balloon that is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss and an improved metabolic profile, with fewer adverse events than reported with other available gastric balloons, results from a meta-analysis show.

“We believe this analysis to be the most comprehensive review [of the Allurion balloon],” reported first author Daryl Ramai, MD, of the division of gastroenterology and hepatology, University of Utah, Salt Lake City, and colleagues in the research, published in the November/December 2021 issue of the Journal of Clinical Gastroenterology.

“Our study showed that the Allurion balloon reduces waist circumference and triglyceride levels and [is] associated with less adverse events when compared with other intragastric balloons,” the authors concluded.

Unlike other balloons, the Allurion gastric balloon is compressed into a small capsule that is connected to a thin catheter and, once swallowed, it is then inflated with 550 mL of liquid through the catheter to create a feeling of fullness and help control hunger.

The procedure can be performed on an outpatient basis in approximately 20 minutes, potentially avoiding the burden and extra costs of surgery or endoscopic placement and removal. After approximately 4 months, the balloon is designed to empty through a valve that spontaneously opens, and the balloon is then passed in the stool.

Though currently used around the world, the balloon does not yet have approval from the Food and Drug Administration.
 

Meta-analysis shows 12.2% average weight loss across studies

To assess the balloon’s performance, the authors identified 7 out of 273 published studies that met the analysis criteria. The studies included 2,152 patients, ranging in age from 18 to 65 years, with a mean baseline body mass index of 32.1-38.6 kg/m2.

All of the studies were prospective, with reported outcomes at 3-4 months, when the Allurion balloon typically deflates. Three of the studies were multicenter, while four were single center.

In terms of improvements in BMI, the results showed the pooled mean difference from baseline through to the end of the studies was 0.88 (P = .001), and the weighted average percentage of total body weight loss during treatment across the studies was 12.2%.

The mean excess body weight loss across the Allurion studies was 49.1%.

The analysis was not designed to directly compare outcomes with other balloons, but the authors note, for instance, that the ReShape Duo intragastric balloon (an FDA-approved dual-balloon system) has been reported in a previous study to be associated with a percentage of total body weight loss of 7.6% at 6 months, compared with 3.6% observed among those with lifestyle modifications.

However, a separate meta-analysis showed the pooled percentage of total body weight loss with the FDA-approved Orbera balloon to be about the same as the current Allurion analysis, at 12.3% at 3 months after implantation (followed by 13.2% at 6 months and 11.3% at 12 months). The analysis further showed excess body weight loss with the Orbera balloon at 12 months to be 25.4%.

In other outcomes, the current meta-analysis also showed significant improvements with the Allurion balloon in waist circumference of 0.89 (P = .001) and in triglyceride levels of 0.66 (P = .004) versus baseline.

Previous research involving the FDA-approved Obalon intragastric balloon, which is inflated with gas rather than liquid, showed a significant reduction in waist circumference from 109 cm (±12.3) to 99 cm (±10.5) (P < .05), and another study showed that 37.5% of patients receiving the Orbera balloon had normalized triglyceride levels after 4 months, without concomitant medical therapy.
 

Adverse events appear lower vs. other balloons

Potential risks associated with the Allurion balloon include the potential for early deflation; however, the pooled rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.

Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%), and small bowel obstruction (0.5%).

The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons have been reported at 54.5% and 57.5%, respectively, with the effects possibly caused by overinflation, the authors noted.

And rates of vomiting with the ReShape Duo and Orbera balloons have been reported as much higher, at 86.7% and 86.8%, respectively.

Of note, there were no deaths or cases of acute pancreatitis reported in the meta-analysis studies of Allurion.

As reported by this news organization, such concerns have been raised in previous FDA alerts regarding the Orbera and ReShape Duo liquid-filled intragastric balloons.

In the most recent update, issued in April 2020, the FDA described receiving reports of 18 deaths that had occurred worldwide since the approvals of the Orbera and ReShape balloons, including eight in the United States.

Dr. Ramai noted that the concern about the issues is warranted.

“These concerns are valid,” he told this news organization. “Theoretically, since the Allurion balloon is placed for a shorter time span, it is conceivable that there may be less adverse events. However, comparative trials are needed to confirm this.”

Although the balloons show efficacy in patients struggling with weight loss, metabolic syndrome, and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Dr. Ramai said.

“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”

The study received no financial support. Dr. Ramai reported no relevant financial relationships.

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

The Allurion intragastric balloon (formerly the Elipse, Allurion Technologies), a novel balloon that is swallowed, requiring no surgery or endoscopic placement, shows high efficacy in achieving weight loss and an improved metabolic profile, with fewer adverse events than reported with other available gastric balloons, results from a meta-analysis show.

“We believe this analysis to be the most comprehensive review [of the Allurion balloon],” reported first author Daryl Ramai, MD, of the division of gastroenterology and hepatology, University of Utah, Salt Lake City, and colleagues in the research, published in the November/December 2021 issue of the Journal of Clinical Gastroenterology.

“Our study showed that the Allurion balloon reduces waist circumference and triglyceride levels and [is] associated with less adverse events when compared with other intragastric balloons,” the authors concluded.

Unlike other balloons, the Allurion gastric balloon is compressed into a small capsule that is connected to a thin catheter and, once swallowed, it is then inflated with 550 mL of liquid through the catheter to create a feeling of fullness and help control hunger.

The procedure can be performed on an outpatient basis in approximately 20 minutes, potentially avoiding the burden and extra costs of surgery or endoscopic placement and removal. After approximately 4 months, the balloon is designed to empty through a valve that spontaneously opens, and the balloon is then passed in the stool.

Though currently used around the world, the balloon does not yet have approval from the Food and Drug Administration.
 

Meta-analysis shows 12.2% average weight loss across studies

To assess the balloon’s performance, the authors identified 7 out of 273 published studies that met the analysis criteria. The studies included 2,152 patients, ranging in age from 18 to 65 years, with a mean baseline body mass index of 32.1-38.6 kg/m2.

All of the studies were prospective, with reported outcomes at 3-4 months, when the Allurion balloon typically deflates. Three of the studies were multicenter, while four were single center.

In terms of improvements in BMI, the results showed the pooled mean difference from baseline through to the end of the studies was 0.88 (P = .001), and the weighted average percentage of total body weight loss during treatment across the studies was 12.2%.

The mean excess body weight loss across the Allurion studies was 49.1%.

The analysis was not designed to directly compare outcomes with other balloons, but the authors note, for instance, that the ReShape Duo intragastric balloon (an FDA-approved dual-balloon system) has been reported in a previous study to be associated with a percentage of total body weight loss of 7.6% at 6 months, compared with 3.6% observed among those with lifestyle modifications.

However, a separate meta-analysis showed the pooled percentage of total body weight loss with the FDA-approved Orbera balloon to be about the same as the current Allurion analysis, at 12.3% at 3 months after implantation (followed by 13.2% at 6 months and 11.3% at 12 months). The analysis further showed excess body weight loss with the Orbera balloon at 12 months to be 25.4%.

In other outcomes, the current meta-analysis also showed significant improvements with the Allurion balloon in waist circumference of 0.89 (P = .001) and in triglyceride levels of 0.66 (P = .004) versus baseline.

Previous research involving the FDA-approved Obalon intragastric balloon, which is inflated with gas rather than liquid, showed a significant reduction in waist circumference from 109 cm (±12.3) to 99 cm (±10.5) (P < .05), and another study showed that 37.5% of patients receiving the Orbera balloon had normalized triglyceride levels after 4 months, without concomitant medical therapy.
 

Adverse events appear lower vs. other balloons

Potential risks associated with the Allurion balloon include the potential for early deflation; however, the pooled rate of early balloon deflation observed in the meta-analysis was relatively low at 1.8%.

Other adverse events reported with the Allurion balloon were abdominal pain (37.5%), vomiting (29.6%), diarrhea (15.4%), and small bowel obstruction (0.5%).

The corresponding rates of abdominal pain with the ReShape Duo and Orbera balloons have been reported at 54.5% and 57.5%, respectively, with the effects possibly caused by overinflation, the authors noted.

And rates of vomiting with the ReShape Duo and Orbera balloons have been reported as much higher, at 86.7% and 86.8%, respectively.

Of note, there were no deaths or cases of acute pancreatitis reported in the meta-analysis studies of Allurion.

As reported by this news organization, such concerns have been raised in previous FDA alerts regarding the Orbera and ReShape Duo liquid-filled intragastric balloons.

In the most recent update, issued in April 2020, the FDA described receiving reports of 18 deaths that had occurred worldwide since the approvals of the Orbera and ReShape balloons, including eight in the United States.

Dr. Ramai noted that the concern about the issues is warranted.

“These concerns are valid,” he told this news organization. “Theoretically, since the Allurion balloon is placed for a shorter time span, it is conceivable that there may be less adverse events. However, comparative trials are needed to confirm this.”

Although the balloons show efficacy in patients struggling with weight loss, metabolic syndrome, and fatty liver disease, “the type and duration of intragastric balloons should be tailored to the patient,” Dr. Ramai said.

“Clinicians should thoroughly discuss with their patients the benefits and risks of using an intragastric balloon,” he added. “Furthermore, placement of intragastric balloons should only be attempted by clinicians with expertise in bariatric endoscopy.”

The study received no financial support. Dr. Ramai reported no relevant financial relationships.

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