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Few patients take weight control medications after bariatric surgery
CHICAGO –
Obesity is a chronic, relapsing condition that must be treated as such, said the study’s author Stephen A. Firkins, MD, a fellow of gastroenterology and hepatology at the Cleveland Clinic. “Barriers to antiobesity medications must be identified.”
“If a quarter of all patients experience weight regain and another quarter experience insufficient weight loss – but only 5% are being prescribed an FDA-approved AOM – that means there’s underutilization,” Dr. Firkins said.
Data from the National Health and Nutrition Examination Survey show that 30.7% of all men and women in the United States are overweight and of these, 42.4% are obese. For the severely obese, bariatric surgery, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass, are viable options with differing degrees of long-term success.
And while antiobesity medications such as orlistat (Xenical, Alli), phentermine/topiramate (Qsymia), naltrexone/bupropion (Contrave), liraglutide (Saxenda), semaglutide (Wegovy), and setmelanotide (Imcivree), may be considered before bariatric surgery, there are questions about the need for its use after surgery.
“While these are often employed or considered presurgically, there is a paucity of literature describing their utilization postsurgically, particularly in regards to newer antiobesity medications such as the [glucagonlike peptide–1] receptor agonists,” Dr. Firkins said.
The aim of Dr. Firkins’ analysis of the large, publicly available IBM Explorys Electronic Health Record, which included 59,160 adult post–bariatric surgery patients, was to identify postoperative weight control medication use and trends among different populations.
He found rates of postsurgical weight control medication use at 8% for topiramate (off label), 2.9% for liraglutide, 1.03% for phentermine/topiramate, 0.95% for naltrexone/bupropion, 0.52% for semaglutide and 0.1% for orlistat. Rates of topiramate use were higher for patients in the 35- 39-year range, and for orlistat and liraglutide in the 65- to 69-year range.
The differences, Dr. Firkins said, were likely related to side-effect profiles and accumulations of comorbidities with advancing age. Black patients were more likely to be prescribed the medications. Also, further analysis showed a significantly higher use of these medications among individuals with hypertension, diabetes, and hyperlipidemia.
The analyses raised several questions for future study, Dr. Firkins said: “What is the optimal timing of antiobesity medication initiation? Is it at the plateau of peak weight loss typically seen at 1-3 years post surgery? Or, after weight is regained? What is the phenotype of patients who are going to be good responders versus poor responders to a particular medication category?”
“Upon recognition of insufficient weight loss/weight regain, a multidisciplinary strategy towards management is warranted, including behavioral and dietary counseling, and consideration of AOM early use, as well as endoscopic or surgical revision,” he said.
Dr. Firkins had no disclosures.
DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.
CHICAGO –
Obesity is a chronic, relapsing condition that must be treated as such, said the study’s author Stephen A. Firkins, MD, a fellow of gastroenterology and hepatology at the Cleveland Clinic. “Barriers to antiobesity medications must be identified.”
“If a quarter of all patients experience weight regain and another quarter experience insufficient weight loss – but only 5% are being prescribed an FDA-approved AOM – that means there’s underutilization,” Dr. Firkins said.
Data from the National Health and Nutrition Examination Survey show that 30.7% of all men and women in the United States are overweight and of these, 42.4% are obese. For the severely obese, bariatric surgery, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass, are viable options with differing degrees of long-term success.
And while antiobesity medications such as orlistat (Xenical, Alli), phentermine/topiramate (Qsymia), naltrexone/bupropion (Contrave), liraglutide (Saxenda), semaglutide (Wegovy), and setmelanotide (Imcivree), may be considered before bariatric surgery, there are questions about the need for its use after surgery.
“While these are often employed or considered presurgically, there is a paucity of literature describing their utilization postsurgically, particularly in regards to newer antiobesity medications such as the [glucagonlike peptide–1] receptor agonists,” Dr. Firkins said.
The aim of Dr. Firkins’ analysis of the large, publicly available IBM Explorys Electronic Health Record, which included 59,160 adult post–bariatric surgery patients, was to identify postoperative weight control medication use and trends among different populations.
He found rates of postsurgical weight control medication use at 8% for topiramate (off label), 2.9% for liraglutide, 1.03% for phentermine/topiramate, 0.95% for naltrexone/bupropion, 0.52% for semaglutide and 0.1% for orlistat. Rates of topiramate use were higher for patients in the 35- 39-year range, and for orlistat and liraglutide in the 65- to 69-year range.
The differences, Dr. Firkins said, were likely related to side-effect profiles and accumulations of comorbidities with advancing age. Black patients were more likely to be prescribed the medications. Also, further analysis showed a significantly higher use of these medications among individuals with hypertension, diabetes, and hyperlipidemia.
The analyses raised several questions for future study, Dr. Firkins said: “What is the optimal timing of antiobesity medication initiation? Is it at the plateau of peak weight loss typically seen at 1-3 years post surgery? Or, after weight is regained? What is the phenotype of patients who are going to be good responders versus poor responders to a particular medication category?”
“Upon recognition of insufficient weight loss/weight regain, a multidisciplinary strategy towards management is warranted, including behavioral and dietary counseling, and consideration of AOM early use, as well as endoscopic or surgical revision,” he said.
Dr. Firkins had no disclosures.
DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.
CHICAGO –
Obesity is a chronic, relapsing condition that must be treated as such, said the study’s author Stephen A. Firkins, MD, a fellow of gastroenterology and hepatology at the Cleveland Clinic. “Barriers to antiobesity medications must be identified.”
“If a quarter of all patients experience weight regain and another quarter experience insufficient weight loss – but only 5% are being prescribed an FDA-approved AOM – that means there’s underutilization,” Dr. Firkins said.
Data from the National Health and Nutrition Examination Survey show that 30.7% of all men and women in the United States are overweight and of these, 42.4% are obese. For the severely obese, bariatric surgery, including sleeve gastrectomy, Roux-en-Y gastric bypass, and one anastomosis gastric bypass, are viable options with differing degrees of long-term success.
And while antiobesity medications such as orlistat (Xenical, Alli), phentermine/topiramate (Qsymia), naltrexone/bupropion (Contrave), liraglutide (Saxenda), semaglutide (Wegovy), and setmelanotide (Imcivree), may be considered before bariatric surgery, there are questions about the need for its use after surgery.
“While these are often employed or considered presurgically, there is a paucity of literature describing their utilization postsurgically, particularly in regards to newer antiobesity medications such as the [glucagonlike peptide–1] receptor agonists,” Dr. Firkins said.
The aim of Dr. Firkins’ analysis of the large, publicly available IBM Explorys Electronic Health Record, which included 59,160 adult post–bariatric surgery patients, was to identify postoperative weight control medication use and trends among different populations.
He found rates of postsurgical weight control medication use at 8% for topiramate (off label), 2.9% for liraglutide, 1.03% for phentermine/topiramate, 0.95% for naltrexone/bupropion, 0.52% for semaglutide and 0.1% for orlistat. Rates of topiramate use were higher for patients in the 35- 39-year range, and for orlistat and liraglutide in the 65- to 69-year range.
The differences, Dr. Firkins said, were likely related to side-effect profiles and accumulations of comorbidities with advancing age. Black patients were more likely to be prescribed the medications. Also, further analysis showed a significantly higher use of these medications among individuals with hypertension, diabetes, and hyperlipidemia.
The analyses raised several questions for future study, Dr. Firkins said: “What is the optimal timing of antiobesity medication initiation? Is it at the plateau of peak weight loss typically seen at 1-3 years post surgery? Or, after weight is regained? What is the phenotype of patients who are going to be good responders versus poor responders to a particular medication category?”
“Upon recognition of insufficient weight loss/weight regain, a multidisciplinary strategy towards management is warranted, including behavioral and dietary counseling, and consideration of AOM early use, as well as endoscopic or surgical revision,” he said.
Dr. Firkins had no disclosures.
DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.
AT DDW 2023
Can a saliva test predict the best way to manage obesity?
It sounds like a simple solution to a complicated problem: Find out what kind of obesity someone has based on a one-time genetic saliva test. Then patients and their doctor can get a better idea if antiobesity drugs or other treatments are more likely to work for them.
It’s what Mayo Clinic researchers had in mind when they created four phenotypes of obesity.
Obesity experts not affiliated with the research have some concerns and say independent studies are needed to verify the potential of this strategy.
This research could help predict who will respond best to popular antiobesity medications, said Andres Acosta, MD, PhD, cofounder of Phenomix Sciences, the company behind the tests. These medications include glucagonlike peptide–1 (GLP-1) receptor agonists like liraglutide (Saxenda, Victoza) and semaglutide (Ozempic, Wegovy).
“We know that not everyone on a GLP-1 will respond. In reality, about a third of the patients don’t do well with GLP-1s,” said Dr. Acosta, an assistant professor of medicine and researcher in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.
Furthest along in development is the “My Phenome Hungry Gut” test for predicting GLP-1 response. People in this Hungry Gut group tend to empty their stomach after a meal faster and are more likely to feel hungry again a short time later, as explained on the company’s website.
A pilot study to test how well it works started in April at three primary care practices. Plans are to expand real-world testing for this and other obesity types later in 2023.
The other obesity categories are:
- “Hungry brain,” where the brain does not recognize signals that the stomach is full
- “Emotional hunger,” where cravings to eat are driven by emotions, anxiety, and negative feelings
- “Slow burn,” where people have a slow metabolism and low energy level
People in these categories might be more likely to benefit from other obesity management strategies, like changes to their diet or placement of an intragastric balloon.
Some things to consider
While applauding their efforts to be more precise in treating people with obesity, not all experts are convinced this saliva test will be the answer. The company’s research might look promising, but verification of results is warranted.
“Can we get better outcomes with things like this? Well, that’s the hope,” said Jaime Almandoz, MD, medical director of weight wellness at the University of Texas Southwestern Medical Center, Dallas.
“We still don’t have randomized trials where we’re looking at obesity phenotyping yet,” said Dr. Almandoz, who is also a spokesperson for the Obesity Society, a professional group of clinicians, researchers, educators, and others focused on obesity science, treatment, and prevention.
There is always concern when a diagnostic test is being developed for commercial use, said Daniel Bessesen, MD, a professor of medicine–endocrinology, metabolism, and diabetes at the University of Colorado at Denver, Aurora. “What they’re talking about doing is super important. But this is a company. This is a company that is, I think, selling a product.”
In an online search, Dr. Bessesen did not find any external studies that showed how well the saliva testing worked. But referring to work by Dr. Acosta and Michael Camilleri, MD, the other cofounder of Phenomix, he said, “I found some papers that they did that I hadn’t read before that are good.”
“These guys are smart guys. And they’ve done a lot of work on [the movement of food through the gut] and how that correlates with obesity and response to some therapies,” said Dr. Bessesen, who is also a spokesperson for the Obesity Society. “So their scientific work does line up with this area.”
Validation of any research is important because the obesity industry has been known for a lot of lose-weight-quick strategies, some with little or no science behind them, he said.
It is also essential, he said, because “anytime you do something commercial in the area of obesity, you have to acknowledge that people with obesity are a vulnerable population. These people face stigma and bias all the time.”
Removing the stigma
If knowing your obesity type ends up making a difference, it could change the conversation people have with their medical provider, Dr. Acosta said. It could also help remove some of the stigma around obesity.
“We’re going to change the conversation because now we can say: ‘Hey, you have obesity because you have ‘Hungry Gut’ phenotype. And because of that, you’re going to respond to this medication,” Dr. Acosta said. The phenotyping suggests a strong genetic tendency – a biologic basis for obesity.
“So it’s not only a way of taking the blame out, but it’s also way of explaining that there’s a reason why you have obesity,” Dr. Acosta said. It tells people: “You’re not a failure.”
More cost-effective treatment?
Targeting obesity treatment could also save on overall health care costs, Dr. Almandoz said. He estimated a cost of $1,400 per month “for forever and ever semaglutide” or at least $1,400 a month for a 3-month trial to see if this medication works in a particular person with obesity.
“That’s a lot of money when you extrapolate that out over the number of people who probably meet the criteria for treatment,” he said. A total 42% of Americans meet the Centers for Disease Control and Prevention definition for obesity.
“You can imagine the potential cost if we were to provide antiobesity therapies to everybody and we were to use what is the most effective class of medication, which is more than a thousand dollars per month, indefinitely,” Dr. Almandoz said. “Not that we should not treat everybody. That’s not the message I’m saying. But if we’re looking at yield or value in terms of treating obesity in a setting with limited resources, it may be best to start with who is most likely to benefit.”
How they created four obesity types
Starting in 2015, Dr. Acosta and colleagues started comparing tests in people with normal weight versus obesity. They used artificial intelligence and machine learning to classify obesity into 11 types at first. They realized this many obesity types were not practical for doctors and people with obesity, so they combined them into four phenotypes.
“The AI machine learning was followed by, as I like to call, HI, or human intelligence,” he said.
The saliva test checks for about 6,000 relevant genetic single-nucleotide polymorphisms. Six thousand genetic changes may sound like a large number to check; however, the average individual carries 5 million and 6 million SNPs in their DNA.
The results are translated to a score that yields a low risk or high risk for Hungry Gut or other types of obesity. “You can have all six thousand genetic mutations, or you can have zero,” Dr. Acosta said.
Moving forward
After the soft launch of Hungry Gut testing in April, Phenomix plans to continue studying their saliva test on other obesity types.
Dr. Acosta is not aware of any direct competitors to Phenomix, although that could change. “I think we’re the only diagnostic company in the space right now. But if it’s really a $14.8 billion market, we’re going to see a lot of diagnostic companies trying to do what we’re doing – if we’re successful,” he said.
An October 2022 report from Polaris Market Research estimates that the global market for obesity treatment – medications, surgery, and all others – was about $14 billion in 2021. The same report predicts the market will grow to $32 billion by 2030.
A version of this article first appeared on WebMD.com.
It sounds like a simple solution to a complicated problem: Find out what kind of obesity someone has based on a one-time genetic saliva test. Then patients and their doctor can get a better idea if antiobesity drugs or other treatments are more likely to work for them.
It’s what Mayo Clinic researchers had in mind when they created four phenotypes of obesity.
Obesity experts not affiliated with the research have some concerns and say independent studies are needed to verify the potential of this strategy.
This research could help predict who will respond best to popular antiobesity medications, said Andres Acosta, MD, PhD, cofounder of Phenomix Sciences, the company behind the tests. These medications include glucagonlike peptide–1 (GLP-1) receptor agonists like liraglutide (Saxenda, Victoza) and semaglutide (Ozempic, Wegovy).
“We know that not everyone on a GLP-1 will respond. In reality, about a third of the patients don’t do well with GLP-1s,” said Dr. Acosta, an assistant professor of medicine and researcher in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.
Furthest along in development is the “My Phenome Hungry Gut” test for predicting GLP-1 response. People in this Hungry Gut group tend to empty their stomach after a meal faster and are more likely to feel hungry again a short time later, as explained on the company’s website.
A pilot study to test how well it works started in April at three primary care practices. Plans are to expand real-world testing for this and other obesity types later in 2023.
The other obesity categories are:
- “Hungry brain,” where the brain does not recognize signals that the stomach is full
- “Emotional hunger,” where cravings to eat are driven by emotions, anxiety, and negative feelings
- “Slow burn,” where people have a slow metabolism and low energy level
People in these categories might be more likely to benefit from other obesity management strategies, like changes to their diet or placement of an intragastric balloon.
Some things to consider
While applauding their efforts to be more precise in treating people with obesity, not all experts are convinced this saliva test will be the answer. The company’s research might look promising, but verification of results is warranted.
“Can we get better outcomes with things like this? Well, that’s the hope,” said Jaime Almandoz, MD, medical director of weight wellness at the University of Texas Southwestern Medical Center, Dallas.
“We still don’t have randomized trials where we’re looking at obesity phenotyping yet,” said Dr. Almandoz, who is also a spokesperson for the Obesity Society, a professional group of clinicians, researchers, educators, and others focused on obesity science, treatment, and prevention.
There is always concern when a diagnostic test is being developed for commercial use, said Daniel Bessesen, MD, a professor of medicine–endocrinology, metabolism, and diabetes at the University of Colorado at Denver, Aurora. “What they’re talking about doing is super important. But this is a company. This is a company that is, I think, selling a product.”
In an online search, Dr. Bessesen did not find any external studies that showed how well the saliva testing worked. But referring to work by Dr. Acosta and Michael Camilleri, MD, the other cofounder of Phenomix, he said, “I found some papers that they did that I hadn’t read before that are good.”
“These guys are smart guys. And they’ve done a lot of work on [the movement of food through the gut] and how that correlates with obesity and response to some therapies,” said Dr. Bessesen, who is also a spokesperson for the Obesity Society. “So their scientific work does line up with this area.”
Validation of any research is important because the obesity industry has been known for a lot of lose-weight-quick strategies, some with little or no science behind them, he said.
It is also essential, he said, because “anytime you do something commercial in the area of obesity, you have to acknowledge that people with obesity are a vulnerable population. These people face stigma and bias all the time.”
Removing the stigma
If knowing your obesity type ends up making a difference, it could change the conversation people have with their medical provider, Dr. Acosta said. It could also help remove some of the stigma around obesity.
“We’re going to change the conversation because now we can say: ‘Hey, you have obesity because you have ‘Hungry Gut’ phenotype. And because of that, you’re going to respond to this medication,” Dr. Acosta said. The phenotyping suggests a strong genetic tendency – a biologic basis for obesity.
“So it’s not only a way of taking the blame out, but it’s also way of explaining that there’s a reason why you have obesity,” Dr. Acosta said. It tells people: “You’re not a failure.”
More cost-effective treatment?
Targeting obesity treatment could also save on overall health care costs, Dr. Almandoz said. He estimated a cost of $1,400 per month “for forever and ever semaglutide” or at least $1,400 a month for a 3-month trial to see if this medication works in a particular person with obesity.
“That’s a lot of money when you extrapolate that out over the number of people who probably meet the criteria for treatment,” he said. A total 42% of Americans meet the Centers for Disease Control and Prevention definition for obesity.
“You can imagine the potential cost if we were to provide antiobesity therapies to everybody and we were to use what is the most effective class of medication, which is more than a thousand dollars per month, indefinitely,” Dr. Almandoz said. “Not that we should not treat everybody. That’s not the message I’m saying. But if we’re looking at yield or value in terms of treating obesity in a setting with limited resources, it may be best to start with who is most likely to benefit.”
How they created four obesity types
Starting in 2015, Dr. Acosta and colleagues started comparing tests in people with normal weight versus obesity. They used artificial intelligence and machine learning to classify obesity into 11 types at first. They realized this many obesity types were not practical for doctors and people with obesity, so they combined them into four phenotypes.
“The AI machine learning was followed by, as I like to call, HI, or human intelligence,” he said.
The saliva test checks for about 6,000 relevant genetic single-nucleotide polymorphisms. Six thousand genetic changes may sound like a large number to check; however, the average individual carries 5 million and 6 million SNPs in their DNA.
The results are translated to a score that yields a low risk or high risk for Hungry Gut or other types of obesity. “You can have all six thousand genetic mutations, or you can have zero,” Dr. Acosta said.
Moving forward
After the soft launch of Hungry Gut testing in April, Phenomix plans to continue studying their saliva test on other obesity types.
Dr. Acosta is not aware of any direct competitors to Phenomix, although that could change. “I think we’re the only diagnostic company in the space right now. But if it’s really a $14.8 billion market, we’re going to see a lot of diagnostic companies trying to do what we’re doing – if we’re successful,” he said.
An October 2022 report from Polaris Market Research estimates that the global market for obesity treatment – medications, surgery, and all others – was about $14 billion in 2021. The same report predicts the market will grow to $32 billion by 2030.
A version of this article first appeared on WebMD.com.
It sounds like a simple solution to a complicated problem: Find out what kind of obesity someone has based on a one-time genetic saliva test. Then patients and their doctor can get a better idea if antiobesity drugs or other treatments are more likely to work for them.
It’s what Mayo Clinic researchers had in mind when they created four phenotypes of obesity.
Obesity experts not affiliated with the research have some concerns and say independent studies are needed to verify the potential of this strategy.
This research could help predict who will respond best to popular antiobesity medications, said Andres Acosta, MD, PhD, cofounder of Phenomix Sciences, the company behind the tests. These medications include glucagonlike peptide–1 (GLP-1) receptor agonists like liraglutide (Saxenda, Victoza) and semaglutide (Ozempic, Wegovy).
“We know that not everyone on a GLP-1 will respond. In reality, about a third of the patients don’t do well with GLP-1s,” said Dr. Acosta, an assistant professor of medicine and researcher in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.
Furthest along in development is the “My Phenome Hungry Gut” test for predicting GLP-1 response. People in this Hungry Gut group tend to empty their stomach after a meal faster and are more likely to feel hungry again a short time later, as explained on the company’s website.
A pilot study to test how well it works started in April at three primary care practices. Plans are to expand real-world testing for this and other obesity types later in 2023.
The other obesity categories are:
- “Hungry brain,” where the brain does not recognize signals that the stomach is full
- “Emotional hunger,” where cravings to eat are driven by emotions, anxiety, and negative feelings
- “Slow burn,” where people have a slow metabolism and low energy level
People in these categories might be more likely to benefit from other obesity management strategies, like changes to their diet or placement of an intragastric balloon.
Some things to consider
While applauding their efforts to be more precise in treating people with obesity, not all experts are convinced this saliva test will be the answer. The company’s research might look promising, but verification of results is warranted.
“Can we get better outcomes with things like this? Well, that’s the hope,” said Jaime Almandoz, MD, medical director of weight wellness at the University of Texas Southwestern Medical Center, Dallas.
“We still don’t have randomized trials where we’re looking at obesity phenotyping yet,” said Dr. Almandoz, who is also a spokesperson for the Obesity Society, a professional group of clinicians, researchers, educators, and others focused on obesity science, treatment, and prevention.
There is always concern when a diagnostic test is being developed for commercial use, said Daniel Bessesen, MD, a professor of medicine–endocrinology, metabolism, and diabetes at the University of Colorado at Denver, Aurora. “What they’re talking about doing is super important. But this is a company. This is a company that is, I think, selling a product.”
In an online search, Dr. Bessesen did not find any external studies that showed how well the saliva testing worked. But referring to work by Dr. Acosta and Michael Camilleri, MD, the other cofounder of Phenomix, he said, “I found some papers that they did that I hadn’t read before that are good.”
“These guys are smart guys. And they’ve done a lot of work on [the movement of food through the gut] and how that correlates with obesity and response to some therapies,” said Dr. Bessesen, who is also a spokesperson for the Obesity Society. “So their scientific work does line up with this area.”
Validation of any research is important because the obesity industry has been known for a lot of lose-weight-quick strategies, some with little or no science behind them, he said.
It is also essential, he said, because “anytime you do something commercial in the area of obesity, you have to acknowledge that people with obesity are a vulnerable population. These people face stigma and bias all the time.”
Removing the stigma
If knowing your obesity type ends up making a difference, it could change the conversation people have with their medical provider, Dr. Acosta said. It could also help remove some of the stigma around obesity.
“We’re going to change the conversation because now we can say: ‘Hey, you have obesity because you have ‘Hungry Gut’ phenotype. And because of that, you’re going to respond to this medication,” Dr. Acosta said. The phenotyping suggests a strong genetic tendency – a biologic basis for obesity.
“So it’s not only a way of taking the blame out, but it’s also way of explaining that there’s a reason why you have obesity,” Dr. Acosta said. It tells people: “You’re not a failure.”
More cost-effective treatment?
Targeting obesity treatment could also save on overall health care costs, Dr. Almandoz said. He estimated a cost of $1,400 per month “for forever and ever semaglutide” or at least $1,400 a month for a 3-month trial to see if this medication works in a particular person with obesity.
“That’s a lot of money when you extrapolate that out over the number of people who probably meet the criteria for treatment,” he said. A total 42% of Americans meet the Centers for Disease Control and Prevention definition for obesity.
“You can imagine the potential cost if we were to provide antiobesity therapies to everybody and we were to use what is the most effective class of medication, which is more than a thousand dollars per month, indefinitely,” Dr. Almandoz said. “Not that we should not treat everybody. That’s not the message I’m saying. But if we’re looking at yield or value in terms of treating obesity in a setting with limited resources, it may be best to start with who is most likely to benefit.”
How they created four obesity types
Starting in 2015, Dr. Acosta and colleagues started comparing tests in people with normal weight versus obesity. They used artificial intelligence and machine learning to classify obesity into 11 types at first. They realized this many obesity types were not practical for doctors and people with obesity, so they combined them into four phenotypes.
“The AI machine learning was followed by, as I like to call, HI, or human intelligence,” he said.
The saliva test checks for about 6,000 relevant genetic single-nucleotide polymorphisms. Six thousand genetic changes may sound like a large number to check; however, the average individual carries 5 million and 6 million SNPs in their DNA.
The results are translated to a score that yields a low risk or high risk for Hungry Gut or other types of obesity. “You can have all six thousand genetic mutations, or you can have zero,” Dr. Acosta said.
Moving forward
After the soft launch of Hungry Gut testing in April, Phenomix plans to continue studying their saliva test on other obesity types.
Dr. Acosta is not aware of any direct competitors to Phenomix, although that could change. “I think we’re the only diagnostic company in the space right now. But if it’s really a $14.8 billion market, we’re going to see a lot of diagnostic companies trying to do what we’re doing – if we’re successful,” he said.
An October 2022 report from Polaris Market Research estimates that the global market for obesity treatment – medications, surgery, and all others – was about $14 billion in 2021. The same report predicts the market will grow to $32 billion by 2030.
A version of this article first appeared on WebMD.com.
Diabetes, cholesterol meds use drops after bariatric surgery
compared with patients with obesity who did not have such an operation. However, these declines didn’t extend to cardiovascular medication use.
“In this study, undergoing bariatric surgery was associated with a substantial and long-lasting reduction in the use of lipid-lowering and antidiabetic medications, compared with no surgery for obesity, while for cardiovascular medications this reduction was only transient,” the authors report in research published in JAMA Surgery.
“The results can aid in informed decision-making when considering bariatric surgery for patients with morbid obesity and inform patients and professionals about the expected long-term effects of medication use for obesity-related comorbidities,” they write.
The study “highlights the benefits of mandated databases that report metabolic bariatric surgery, obesity-related comorbidities, and medications,” writes Paulina Salminen, MD, in an accompanying editorial.
However, key limitations include a lack of weight data, which is important in light of previous studies showing that suboptimal weight loss after bariatric surgery is linked to a higher incidence of type 2 diabetes, dyslipidemia, and hypertension, note Dr. Salminen, of the department of digestive surgery, University Hospital, Turku, Finland, and colleagues.
Swedish, Finnish obesity data probed
When significant weight loss is achieved, bariatric surgery has been well documented to be associated with improvements in a variety of comorbidities, quality of life, and even life expectancy.
Key comorbidities shown to improve with the surgery include hyperlipidemia, cardiovascular disease, and type 2 diabetes.
However, data are lacking on the association between bariatric surgery and the use of medications for those conditions, particularly compared with people with obesity who don’t have bariatric surgery.
To investigate, first author Joonas H. Kauppila, MD, PhD, of Upper Gastrointestinal Surgery, Karolinska University Hospital, Stockholm, and colleagues conducted a population-based cohort study, evaluating data on 26,396 patients who underwent bariatric surgery with gastric bypass or sleeve gastrectomy in Sweden between 2005 and 2020 or Finland between 1995 and 2018.
Overall, 66.4% of patients were women and their median age was 50.
They were compared with five times as many matched controls with obesity who had not had bariatric surgery from the same population databases, representing a total of 131,980 patients who were matched based on age, country, sex, calendar year, and medication use.
In terms of lipid-lowering medication, rates of use after bariatric surgery decreased from 20.3% at baseline to 12.9% after 2 years and bounced back somewhat to 17.6% after 15 years. Comparatively, in the no surgery group, baseline lipid-lowering medication use of 21.0% increased to 44.6% after 15 years, more than twice the rate of usage in the bariatric surgery group in the same period.
Antidiabetic medications were used by 27.7% of patients in the bariatric surgery group at baseline, with a drop to 10.0% after 2 years, followed by an increase to 23.5% after 15 years. In the no surgery group, the rate of antidiabetic medication use steadily increased from 27.7% at baseline to 54.2% after 15 years, which again was nearly double the rate of antidiabetic medication use in the bariatric surgery group at 15 years.
Meanwhile, cardiovascular medications were used by 60.2% of patients receiving bariatric surgery at baseline, with the rate decreasing to 43.2% after 2 years but increasing to 74.6% after 15 years. Among the nonbariatric surgery patients, use of cardiovascular medications increased from 54.4% at baseline to 83.3% after 15 years.
Causes?
As for the cause of the lack of any decline in use of cardiovascular medications versus other medications in the surgery patients, the authors speculate that the effect “may be related to aging and regain of weight over time after bariatric surgery, a phenomenon caused by hormonal, dietary, physical, and behavioral factors.”
“In contrast, as expected, a gradual increase in the use of all three medication groups was observed over time among the patients treated with no surgery for obesity,” they note.
The lower medication use with bariatric surgery can also translate to economic benefits, the authors add.
“Economically, the long-lasting reductions in medication use for hyperlipidemia, cardiovascular morbidity, and diabetes suggest that surgical treatment of morbid obesity may infer savings in medication expenses for patients, health care, and society,” they report.
“Future research may focus on subgroups that are most likely to benefit from bariatric surgery, including resolution and severity of comorbidities,” they continue.
In their editorial, Dr. Salminen and colleagues note that previous research has shown remission of dyslipidemia in up to 70% of patients after bariatric surgery that was independent of weight loss, which appears to support the sustained reduction in lipid-lowering medications following surgery observed in the current study, suggesting some benefits on lipids beyond weight loss.
Other limitations, however, include that the bariatric surgery group in the study was older and had more comorbidities than those in previous bariatric surgery studies.
“Future studies should assess this in a younger cohort with less disease at baseline and differentiation within cardiovascular disease regarding at least hypertension, ischemic heart disease, and heart failure,” the authors conclude.
The authors have reported no relevant financial relationships. Dr. Salminen has reported receiving grants from the Sigrid Jusélius Foundation, Academy of Finland, Government Research Grant Foundation, and the University of Turku (Finland).
A version of this article first appeared on Medscape.com.
compared with patients with obesity who did not have such an operation. However, these declines didn’t extend to cardiovascular medication use.
“In this study, undergoing bariatric surgery was associated with a substantial and long-lasting reduction in the use of lipid-lowering and antidiabetic medications, compared with no surgery for obesity, while for cardiovascular medications this reduction was only transient,” the authors report in research published in JAMA Surgery.
“The results can aid in informed decision-making when considering bariatric surgery for patients with morbid obesity and inform patients and professionals about the expected long-term effects of medication use for obesity-related comorbidities,” they write.
The study “highlights the benefits of mandated databases that report metabolic bariatric surgery, obesity-related comorbidities, and medications,” writes Paulina Salminen, MD, in an accompanying editorial.
However, key limitations include a lack of weight data, which is important in light of previous studies showing that suboptimal weight loss after bariatric surgery is linked to a higher incidence of type 2 diabetes, dyslipidemia, and hypertension, note Dr. Salminen, of the department of digestive surgery, University Hospital, Turku, Finland, and colleagues.
Swedish, Finnish obesity data probed
When significant weight loss is achieved, bariatric surgery has been well documented to be associated with improvements in a variety of comorbidities, quality of life, and even life expectancy.
Key comorbidities shown to improve with the surgery include hyperlipidemia, cardiovascular disease, and type 2 diabetes.
However, data are lacking on the association between bariatric surgery and the use of medications for those conditions, particularly compared with people with obesity who don’t have bariatric surgery.
To investigate, first author Joonas H. Kauppila, MD, PhD, of Upper Gastrointestinal Surgery, Karolinska University Hospital, Stockholm, and colleagues conducted a population-based cohort study, evaluating data on 26,396 patients who underwent bariatric surgery with gastric bypass or sleeve gastrectomy in Sweden between 2005 and 2020 or Finland between 1995 and 2018.
Overall, 66.4% of patients were women and their median age was 50.
They were compared with five times as many matched controls with obesity who had not had bariatric surgery from the same population databases, representing a total of 131,980 patients who were matched based on age, country, sex, calendar year, and medication use.
In terms of lipid-lowering medication, rates of use after bariatric surgery decreased from 20.3% at baseline to 12.9% after 2 years and bounced back somewhat to 17.6% after 15 years. Comparatively, in the no surgery group, baseline lipid-lowering medication use of 21.0% increased to 44.6% after 15 years, more than twice the rate of usage in the bariatric surgery group in the same period.
Antidiabetic medications were used by 27.7% of patients in the bariatric surgery group at baseline, with a drop to 10.0% after 2 years, followed by an increase to 23.5% after 15 years. In the no surgery group, the rate of antidiabetic medication use steadily increased from 27.7% at baseline to 54.2% after 15 years, which again was nearly double the rate of antidiabetic medication use in the bariatric surgery group at 15 years.
Meanwhile, cardiovascular medications were used by 60.2% of patients receiving bariatric surgery at baseline, with the rate decreasing to 43.2% after 2 years but increasing to 74.6% after 15 years. Among the nonbariatric surgery patients, use of cardiovascular medications increased from 54.4% at baseline to 83.3% after 15 years.
Causes?
As for the cause of the lack of any decline in use of cardiovascular medications versus other medications in the surgery patients, the authors speculate that the effect “may be related to aging and regain of weight over time after bariatric surgery, a phenomenon caused by hormonal, dietary, physical, and behavioral factors.”
“In contrast, as expected, a gradual increase in the use of all three medication groups was observed over time among the patients treated with no surgery for obesity,” they note.
The lower medication use with bariatric surgery can also translate to economic benefits, the authors add.
“Economically, the long-lasting reductions in medication use for hyperlipidemia, cardiovascular morbidity, and diabetes suggest that surgical treatment of morbid obesity may infer savings in medication expenses for patients, health care, and society,” they report.
“Future research may focus on subgroups that are most likely to benefit from bariatric surgery, including resolution and severity of comorbidities,” they continue.
In their editorial, Dr. Salminen and colleagues note that previous research has shown remission of dyslipidemia in up to 70% of patients after bariatric surgery that was independent of weight loss, which appears to support the sustained reduction in lipid-lowering medications following surgery observed in the current study, suggesting some benefits on lipids beyond weight loss.
Other limitations, however, include that the bariatric surgery group in the study was older and had more comorbidities than those in previous bariatric surgery studies.
“Future studies should assess this in a younger cohort with less disease at baseline and differentiation within cardiovascular disease regarding at least hypertension, ischemic heart disease, and heart failure,” the authors conclude.
The authors have reported no relevant financial relationships. Dr. Salminen has reported receiving grants from the Sigrid Jusélius Foundation, Academy of Finland, Government Research Grant Foundation, and the University of Turku (Finland).
A version of this article first appeared on Medscape.com.
compared with patients with obesity who did not have such an operation. However, these declines didn’t extend to cardiovascular medication use.
“In this study, undergoing bariatric surgery was associated with a substantial and long-lasting reduction in the use of lipid-lowering and antidiabetic medications, compared with no surgery for obesity, while for cardiovascular medications this reduction was only transient,” the authors report in research published in JAMA Surgery.
“The results can aid in informed decision-making when considering bariatric surgery for patients with morbid obesity and inform patients and professionals about the expected long-term effects of medication use for obesity-related comorbidities,” they write.
The study “highlights the benefits of mandated databases that report metabolic bariatric surgery, obesity-related comorbidities, and medications,” writes Paulina Salminen, MD, in an accompanying editorial.
However, key limitations include a lack of weight data, which is important in light of previous studies showing that suboptimal weight loss after bariatric surgery is linked to a higher incidence of type 2 diabetes, dyslipidemia, and hypertension, note Dr. Salminen, of the department of digestive surgery, University Hospital, Turku, Finland, and colleagues.
Swedish, Finnish obesity data probed
When significant weight loss is achieved, bariatric surgery has been well documented to be associated with improvements in a variety of comorbidities, quality of life, and even life expectancy.
Key comorbidities shown to improve with the surgery include hyperlipidemia, cardiovascular disease, and type 2 diabetes.
However, data are lacking on the association between bariatric surgery and the use of medications for those conditions, particularly compared with people with obesity who don’t have bariatric surgery.
To investigate, first author Joonas H. Kauppila, MD, PhD, of Upper Gastrointestinal Surgery, Karolinska University Hospital, Stockholm, and colleagues conducted a population-based cohort study, evaluating data on 26,396 patients who underwent bariatric surgery with gastric bypass or sleeve gastrectomy in Sweden between 2005 and 2020 or Finland between 1995 and 2018.
Overall, 66.4% of patients were women and their median age was 50.
They were compared with five times as many matched controls with obesity who had not had bariatric surgery from the same population databases, representing a total of 131,980 patients who were matched based on age, country, sex, calendar year, and medication use.
In terms of lipid-lowering medication, rates of use after bariatric surgery decreased from 20.3% at baseline to 12.9% after 2 years and bounced back somewhat to 17.6% after 15 years. Comparatively, in the no surgery group, baseline lipid-lowering medication use of 21.0% increased to 44.6% after 15 years, more than twice the rate of usage in the bariatric surgery group in the same period.
Antidiabetic medications were used by 27.7% of patients in the bariatric surgery group at baseline, with a drop to 10.0% after 2 years, followed by an increase to 23.5% after 15 years. In the no surgery group, the rate of antidiabetic medication use steadily increased from 27.7% at baseline to 54.2% after 15 years, which again was nearly double the rate of antidiabetic medication use in the bariatric surgery group at 15 years.
Meanwhile, cardiovascular medications were used by 60.2% of patients receiving bariatric surgery at baseline, with the rate decreasing to 43.2% after 2 years but increasing to 74.6% after 15 years. Among the nonbariatric surgery patients, use of cardiovascular medications increased from 54.4% at baseline to 83.3% after 15 years.
Causes?
As for the cause of the lack of any decline in use of cardiovascular medications versus other medications in the surgery patients, the authors speculate that the effect “may be related to aging and regain of weight over time after bariatric surgery, a phenomenon caused by hormonal, dietary, physical, and behavioral factors.”
“In contrast, as expected, a gradual increase in the use of all three medication groups was observed over time among the patients treated with no surgery for obesity,” they note.
The lower medication use with bariatric surgery can also translate to economic benefits, the authors add.
“Economically, the long-lasting reductions in medication use for hyperlipidemia, cardiovascular morbidity, and diabetes suggest that surgical treatment of morbid obesity may infer savings in medication expenses for patients, health care, and society,” they report.
“Future research may focus on subgroups that are most likely to benefit from bariatric surgery, including resolution and severity of comorbidities,” they continue.
In their editorial, Dr. Salminen and colleagues note that previous research has shown remission of dyslipidemia in up to 70% of patients after bariatric surgery that was independent of weight loss, which appears to support the sustained reduction in lipid-lowering medications following surgery observed in the current study, suggesting some benefits on lipids beyond weight loss.
Other limitations, however, include that the bariatric surgery group in the study was older and had more comorbidities than those in previous bariatric surgery studies.
“Future studies should assess this in a younger cohort with less disease at baseline and differentiation within cardiovascular disease regarding at least hypertension, ischemic heart disease, and heart failure,” the authors conclude.
The authors have reported no relevant financial relationships. Dr. Salminen has reported receiving grants from the Sigrid Jusélius Foundation, Academy of Finland, Government Research Grant Foundation, and the University of Turku (Finland).
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY
Does Ozempic cause hair loss?
Should people be concerned about possible hair loss when taking Wegovy, Ozempic, or Mounjaro for weight loss (where the latter two drugs are being used off label) – as was recently claimed by some people on social media and reported in news stories?
The consensus among dermatologists and endocrinologists is no.
It’s up to the individual to weigh the benefits of treating obesity against the risks of the therapy, including the low risk of developing temporary hair loss, says one expert.
Wegovy, Ozempic, and Mounjaro
Of these three newer medications, only the glucagonlike peptide–1 (GLP-1) receptor agonist semaglutide (Wegovy) is approved by the Food and Drug Administration (since June 2021) for weight management – specifically for people with either obesity (body mass index ≥ 30 kg/m2) or overweight (BMI ≥ 27) plus at least one weight-related comorbidity such as hypertension, type 2 diabetes, and high cholesterol – with a dosage up to a 2.4-mg weekly injection.
When there was a short supply of Wegovy soon after it became available, some people turned to the same drug – semaglutide, but marketed as Ozempic for type 2 diabetes, which is titrated up to a 2-mg weekly injection. Still others opted for tirzepatide (Mounjaro), a dual GLP-1 agonist and glucose-dependent insulinotropic polypeptide (GIP) agonist. Tirzepatide is approved for type 2 diabetes in the United States but is not yet approved for weight loss.
Wegovy shortages continue to be reported.
; of interest, it was more common after bariatric surgery.
In clinical trials, 3% of patients receiving Wegovy (a 2.4-mg/wk injection) versus 1% of patients receiving placebo reported alopecia. Hair loss was not reported as a side effect in clinical trials of Ozempic (a 2-mg/wk injection) for type 2 diabetes. In a clinical trial of tirzepatide for weight loss in obesity, 5.7% of patients taking the highest dose (a 15-mg once-weekly injection) reported alopecia vs 1% of those who got a placebo.
In contrast, a review of 18 mostly observational studies reported that 57% of patients had hair loss after bariatric surgery.
Is it the drug or the rapid weight loss?
None of the experts consulted for this article had seen patients who came to them about hair loss while taking these drugs for weight loss.
“I have not seen patients complaining of hair loss from these medications, but perhaps it is just a matter of time,” said Lynne J. Goldberg, MD, a professor of dermatology and pathology and laboratory medicine, at Boston University, and director of the hair clinic at Boston Medical Center.
“Some of my patients lose hair when they lose weight, generally as a result of the weight loss itself and not as a side effect of these medications,” said Katharine H. Saunders, MD, an obesity medicine physician, cofounder of Intellihealth, and an assistant professor of medicine at Weill Cornell Medicine, New York.
“Hair loss from rapid weight loss is very common [and] not necessarily a side effect of the medication itself but more as a result of how quickly the weight loss occurs,” echoed Susan Massick, MD, associate professor of dermatology, Ohio State University, and a dermatologist at Ohio State’s Wexner Medical Center, both in Columbus.
“Hair loss is tricky,” observed Anne Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles. “Losing weight and/or changing your diet causes hair loss. Stress can cause hair loss. So, it is hard to separate weight loss from medication effect.”
Telogen effluvium (stress shedding) with rapid weight loss
The hair loss seems to be associated with rapid weight loss, the experts agreed.
“It is rare, but we can see patients who have a period of diffuse hair loss, called telogen effluvium, or ‘stress shedding’ with rapid weight loss,” said Michael A. Weintraub, MD, an endocrinologist at NYU Langone Health, New York.
This hair loss occurs in relation to either physical (surgery, pregnancy, illness) or emotional stress, added Dr. Weintraub, who is an assistant professor at NYU Grossman School of Medicine.
Hair loss caused by rapid weight loss could be caused by an antiobesity medication, but it could also occur with other obesity treatments, such as bariatric surgery or drastic dietary changes, he said. The hair shedding is typically short lived and reversible.
About 80%-85% of hair is in the anagen (growth) phase, about 5% is in a transitional (catagen) phase, and the rest is in telogen (resting, or shedding) phase, Dr. Massick explained. In telogen effluvium, hairs that are normally in the growth phase get suddenly shifted to telogen phase and are shed rapidly.
“Telogen effluvium can be caused by rapid weight loss, major surgery, severe COVID infection, high fever, or death in the family,” she noted. “You will not go bald with telogen effluvium, but you might find that you may lose a good volume of hair,” much more than the normal loss of up to 100 hairs a day.
“I counsel my patients about the possibility of losing hair before they undergo bariatric surgery,” Dr. Saunders said. “Generally, the health benefits of weight loss and weight maintenance outweigh the risk of temporary hair loss.”
Nutritional deficiencies and malnutrition can contribute to hair loss as well, and iron deficiency is sometimes a culprit, she added.
“If someone is worried” about hair loss associated with weight loss, “they should see their doctor,” Dr. Peters said. “If they are on thyroid hormone, in particular, the levels should be retested after weight loss.”
Hair loss appears more common after bariatric surgery than with antiobesity medications,” Dr. Weintraub observed, and it is unclear whether this is because the weight loss is more dramatic after surgery and thus a greater stressor, or whether it is caused by nutrient deficiency or a different mechanism entirely.
“Unlike certain forms of bariatric surgery, which can lead to malabsorption (e.g., Roux-en-Y gastric bypass), medications such as GLP-1 agonists and GLP-1/GIP dual agonists do not cause malabsorption,” Dr. Weintraub noted. “So nutritional deficiencies are less likely to be the cause of new hair loss in those taking antiobesity medications than [in] someone who underwent bariatric surgery.”
Iron and vitamin D deficiencies are the most common nutritional deficiencies that can cause hair loss, he noted.
Slow and steady weight loss rather than rapid
“I would suggest that patients try to keep the weight loss slow and steady, rather than rapid,” Dr. Goldberg said, “and follow any vitamin/mineral supplementation plan that they are given. Patients with bariatric surgery have nutritional guidance and a supplementation plan.”
“Follow a well-balanced dietary strategy with ample protein, vegetables, and some fruit,” Dr. Saunders said. Health care providers should monitor lab tests to check for and treat vitamin deficiencies, and registered dietitians can be crucial to ensure proper nutrition. She advises patients: “Find coping strategies to reduce stress and get enough sleep. If iron levels are low, start an iron supplement under your provider’s supervision.”
“Some of my patients swear by biotin supplements, prenatal vitamins or ‘hair, skin, and nails’ vitamins,” she added. If hair loss doesn’t stop, a dermatologist can look for other contributors and discuss strategies for hair restoration.
Individuals who undergo bariatric surgery require lifelong vitamin supplementation and yearly (or more frequent) lab testing, she noted.
“With, for example, bariatric surgery or any type of diet change you want to make sure you still maintain a balanced diet, whether its calories, protein, iron, zinc, vitamins (vitamin D for example),” Dr. Massick echoed.
Similarly, Dr. Peters advised: “I would say to maintain a normal healthy diet even if eating less. Exercise. Do all those healthy things. Taking a daily multivitamin isn’t a bad idea. Talk with a nutritionist. Use the appetite suppression of the medication to combine with healthy eating.”
“If someone is having new hair loss, they should see their clinician to evaluate for all possible causes,” Dr. Weintraub said. “Their provider can evaluate for underlying causes like thyroid dysfunction, iron deficiency, and vitamin D deficiency.”
However, if a patient’s pattern of hair loss is not diffuse but occurs in patches, this has an entirely different set of etiologies probably unrelated to antiobesity medication and should be evaluated.
Working with a nutritionist to ensure that patients have sufficient protein and micronutrient intake can lower the risk of developing hair loss and other complications, Dr. Weintraub said. “This is particularly important for certain forms of bariatric surgery such as Roux-en-Y gastric bypass, since that can lead to malabsorption of specific vitamins and minerals that need to be periodically measured and supplemented.”
In individuals starting an antiobesity medication, beginning a daily multivitamin has little harm, he added, and can ensure they are getting essential minerals and vitamins. However, no studies have specifically investigated this yet.
“Ultimately, it’s important to weigh the benefits of antiobesity medications against the potential risks, as we do with any medical intervention,” according to Dr. Weintraub.
“The purpose of treating obesity,” he stressed, “is to reduce the risk of heart disease, stroke, and multiple types of cancers. It’s up to the individual to weigh these benefits against the risks of the treatment, including the low risk of developing temporary hair loss.”
Dr. Peters writes a column for Medscape and disclosed that she served as a consultant for Blue Circle Health, Vertex, and Abbott Diabetes Care; received a research grant from Abbott Diabetes Care; and received stock options from Teladoc and Omada Health. Dr. Goldberg, Dr. Saunders, Dr. Massick, and Dr. Weintraub declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Should people be concerned about possible hair loss when taking Wegovy, Ozempic, or Mounjaro for weight loss (where the latter two drugs are being used off label) – as was recently claimed by some people on social media and reported in news stories?
The consensus among dermatologists and endocrinologists is no.
It’s up to the individual to weigh the benefits of treating obesity against the risks of the therapy, including the low risk of developing temporary hair loss, says one expert.
Wegovy, Ozempic, and Mounjaro
Of these three newer medications, only the glucagonlike peptide–1 (GLP-1) receptor agonist semaglutide (Wegovy) is approved by the Food and Drug Administration (since June 2021) for weight management – specifically for people with either obesity (body mass index ≥ 30 kg/m2) or overweight (BMI ≥ 27) plus at least one weight-related comorbidity such as hypertension, type 2 diabetes, and high cholesterol – with a dosage up to a 2.4-mg weekly injection.
When there was a short supply of Wegovy soon after it became available, some people turned to the same drug – semaglutide, but marketed as Ozempic for type 2 diabetes, which is titrated up to a 2-mg weekly injection. Still others opted for tirzepatide (Mounjaro), a dual GLP-1 agonist and glucose-dependent insulinotropic polypeptide (GIP) agonist. Tirzepatide is approved for type 2 diabetes in the United States but is not yet approved for weight loss.
Wegovy shortages continue to be reported.
; of interest, it was more common after bariatric surgery.
In clinical trials, 3% of patients receiving Wegovy (a 2.4-mg/wk injection) versus 1% of patients receiving placebo reported alopecia. Hair loss was not reported as a side effect in clinical trials of Ozempic (a 2-mg/wk injection) for type 2 diabetes. In a clinical trial of tirzepatide for weight loss in obesity, 5.7% of patients taking the highest dose (a 15-mg once-weekly injection) reported alopecia vs 1% of those who got a placebo.
In contrast, a review of 18 mostly observational studies reported that 57% of patients had hair loss after bariatric surgery.
Is it the drug or the rapid weight loss?
None of the experts consulted for this article had seen patients who came to them about hair loss while taking these drugs for weight loss.
“I have not seen patients complaining of hair loss from these medications, but perhaps it is just a matter of time,” said Lynne J. Goldberg, MD, a professor of dermatology and pathology and laboratory medicine, at Boston University, and director of the hair clinic at Boston Medical Center.
“Some of my patients lose hair when they lose weight, generally as a result of the weight loss itself and not as a side effect of these medications,” said Katharine H. Saunders, MD, an obesity medicine physician, cofounder of Intellihealth, and an assistant professor of medicine at Weill Cornell Medicine, New York.
“Hair loss from rapid weight loss is very common [and] not necessarily a side effect of the medication itself but more as a result of how quickly the weight loss occurs,” echoed Susan Massick, MD, associate professor of dermatology, Ohio State University, and a dermatologist at Ohio State’s Wexner Medical Center, both in Columbus.
“Hair loss is tricky,” observed Anne Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles. “Losing weight and/or changing your diet causes hair loss. Stress can cause hair loss. So, it is hard to separate weight loss from medication effect.”
Telogen effluvium (stress shedding) with rapid weight loss
The hair loss seems to be associated with rapid weight loss, the experts agreed.
“It is rare, but we can see patients who have a period of diffuse hair loss, called telogen effluvium, or ‘stress shedding’ with rapid weight loss,” said Michael A. Weintraub, MD, an endocrinologist at NYU Langone Health, New York.
This hair loss occurs in relation to either physical (surgery, pregnancy, illness) or emotional stress, added Dr. Weintraub, who is an assistant professor at NYU Grossman School of Medicine.
Hair loss caused by rapid weight loss could be caused by an antiobesity medication, but it could also occur with other obesity treatments, such as bariatric surgery or drastic dietary changes, he said. The hair shedding is typically short lived and reversible.
About 80%-85% of hair is in the anagen (growth) phase, about 5% is in a transitional (catagen) phase, and the rest is in telogen (resting, or shedding) phase, Dr. Massick explained. In telogen effluvium, hairs that are normally in the growth phase get suddenly shifted to telogen phase and are shed rapidly.
“Telogen effluvium can be caused by rapid weight loss, major surgery, severe COVID infection, high fever, or death in the family,” she noted. “You will not go bald with telogen effluvium, but you might find that you may lose a good volume of hair,” much more than the normal loss of up to 100 hairs a day.
“I counsel my patients about the possibility of losing hair before they undergo bariatric surgery,” Dr. Saunders said. “Generally, the health benefits of weight loss and weight maintenance outweigh the risk of temporary hair loss.”
Nutritional deficiencies and malnutrition can contribute to hair loss as well, and iron deficiency is sometimes a culprit, she added.
“If someone is worried” about hair loss associated with weight loss, “they should see their doctor,” Dr. Peters said. “If they are on thyroid hormone, in particular, the levels should be retested after weight loss.”
Hair loss appears more common after bariatric surgery than with antiobesity medications,” Dr. Weintraub observed, and it is unclear whether this is because the weight loss is more dramatic after surgery and thus a greater stressor, or whether it is caused by nutrient deficiency or a different mechanism entirely.
“Unlike certain forms of bariatric surgery, which can lead to malabsorption (e.g., Roux-en-Y gastric bypass), medications such as GLP-1 agonists and GLP-1/GIP dual agonists do not cause malabsorption,” Dr. Weintraub noted. “So nutritional deficiencies are less likely to be the cause of new hair loss in those taking antiobesity medications than [in] someone who underwent bariatric surgery.”
Iron and vitamin D deficiencies are the most common nutritional deficiencies that can cause hair loss, he noted.
Slow and steady weight loss rather than rapid
“I would suggest that patients try to keep the weight loss slow and steady, rather than rapid,” Dr. Goldberg said, “and follow any vitamin/mineral supplementation plan that they are given. Patients with bariatric surgery have nutritional guidance and a supplementation plan.”
“Follow a well-balanced dietary strategy with ample protein, vegetables, and some fruit,” Dr. Saunders said. Health care providers should monitor lab tests to check for and treat vitamin deficiencies, and registered dietitians can be crucial to ensure proper nutrition. She advises patients: “Find coping strategies to reduce stress and get enough sleep. If iron levels are low, start an iron supplement under your provider’s supervision.”
“Some of my patients swear by biotin supplements, prenatal vitamins or ‘hair, skin, and nails’ vitamins,” she added. If hair loss doesn’t stop, a dermatologist can look for other contributors and discuss strategies for hair restoration.
Individuals who undergo bariatric surgery require lifelong vitamin supplementation and yearly (or more frequent) lab testing, she noted.
“With, for example, bariatric surgery or any type of diet change you want to make sure you still maintain a balanced diet, whether its calories, protein, iron, zinc, vitamins (vitamin D for example),” Dr. Massick echoed.
Similarly, Dr. Peters advised: “I would say to maintain a normal healthy diet even if eating less. Exercise. Do all those healthy things. Taking a daily multivitamin isn’t a bad idea. Talk with a nutritionist. Use the appetite suppression of the medication to combine with healthy eating.”
“If someone is having new hair loss, they should see their clinician to evaluate for all possible causes,” Dr. Weintraub said. “Their provider can evaluate for underlying causes like thyroid dysfunction, iron deficiency, and vitamin D deficiency.”
However, if a patient’s pattern of hair loss is not diffuse but occurs in patches, this has an entirely different set of etiologies probably unrelated to antiobesity medication and should be evaluated.
Working with a nutritionist to ensure that patients have sufficient protein and micronutrient intake can lower the risk of developing hair loss and other complications, Dr. Weintraub said. “This is particularly important for certain forms of bariatric surgery such as Roux-en-Y gastric bypass, since that can lead to malabsorption of specific vitamins and minerals that need to be periodically measured and supplemented.”
In individuals starting an antiobesity medication, beginning a daily multivitamin has little harm, he added, and can ensure they are getting essential minerals and vitamins. However, no studies have specifically investigated this yet.
“Ultimately, it’s important to weigh the benefits of antiobesity medications against the potential risks, as we do with any medical intervention,” according to Dr. Weintraub.
“The purpose of treating obesity,” he stressed, “is to reduce the risk of heart disease, stroke, and multiple types of cancers. It’s up to the individual to weigh these benefits against the risks of the treatment, including the low risk of developing temporary hair loss.”
Dr. Peters writes a column for Medscape and disclosed that she served as a consultant for Blue Circle Health, Vertex, and Abbott Diabetes Care; received a research grant from Abbott Diabetes Care; and received stock options from Teladoc and Omada Health. Dr. Goldberg, Dr. Saunders, Dr. Massick, and Dr. Weintraub declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Should people be concerned about possible hair loss when taking Wegovy, Ozempic, or Mounjaro for weight loss (where the latter two drugs are being used off label) – as was recently claimed by some people on social media and reported in news stories?
The consensus among dermatologists and endocrinologists is no.
It’s up to the individual to weigh the benefits of treating obesity against the risks of the therapy, including the low risk of developing temporary hair loss, says one expert.
Wegovy, Ozempic, and Mounjaro
Of these three newer medications, only the glucagonlike peptide–1 (GLP-1) receptor agonist semaglutide (Wegovy) is approved by the Food and Drug Administration (since June 2021) for weight management – specifically for people with either obesity (body mass index ≥ 30 kg/m2) or overweight (BMI ≥ 27) plus at least one weight-related comorbidity such as hypertension, type 2 diabetes, and high cholesterol – with a dosage up to a 2.4-mg weekly injection.
When there was a short supply of Wegovy soon after it became available, some people turned to the same drug – semaglutide, but marketed as Ozempic for type 2 diabetes, which is titrated up to a 2-mg weekly injection. Still others opted for tirzepatide (Mounjaro), a dual GLP-1 agonist and glucose-dependent insulinotropic polypeptide (GIP) agonist. Tirzepatide is approved for type 2 diabetes in the United States but is not yet approved for weight loss.
Wegovy shortages continue to be reported.
; of interest, it was more common after bariatric surgery.
In clinical trials, 3% of patients receiving Wegovy (a 2.4-mg/wk injection) versus 1% of patients receiving placebo reported alopecia. Hair loss was not reported as a side effect in clinical trials of Ozempic (a 2-mg/wk injection) for type 2 diabetes. In a clinical trial of tirzepatide for weight loss in obesity, 5.7% of patients taking the highest dose (a 15-mg once-weekly injection) reported alopecia vs 1% of those who got a placebo.
In contrast, a review of 18 mostly observational studies reported that 57% of patients had hair loss after bariatric surgery.
Is it the drug or the rapid weight loss?
None of the experts consulted for this article had seen patients who came to them about hair loss while taking these drugs for weight loss.
“I have not seen patients complaining of hair loss from these medications, but perhaps it is just a matter of time,” said Lynne J. Goldberg, MD, a professor of dermatology and pathology and laboratory medicine, at Boston University, and director of the hair clinic at Boston Medical Center.
“Some of my patients lose hair when they lose weight, generally as a result of the weight loss itself and not as a side effect of these medications,” said Katharine H. Saunders, MD, an obesity medicine physician, cofounder of Intellihealth, and an assistant professor of medicine at Weill Cornell Medicine, New York.
“Hair loss from rapid weight loss is very common [and] not necessarily a side effect of the medication itself but more as a result of how quickly the weight loss occurs,” echoed Susan Massick, MD, associate professor of dermatology, Ohio State University, and a dermatologist at Ohio State’s Wexner Medical Center, both in Columbus.
“Hair loss is tricky,” observed Anne Peters, MD, director of clinical diabetes programs at the University of Southern California, Los Angeles. “Losing weight and/or changing your diet causes hair loss. Stress can cause hair loss. So, it is hard to separate weight loss from medication effect.”
Telogen effluvium (stress shedding) with rapid weight loss
The hair loss seems to be associated with rapid weight loss, the experts agreed.
“It is rare, but we can see patients who have a period of diffuse hair loss, called telogen effluvium, or ‘stress shedding’ with rapid weight loss,” said Michael A. Weintraub, MD, an endocrinologist at NYU Langone Health, New York.
This hair loss occurs in relation to either physical (surgery, pregnancy, illness) or emotional stress, added Dr. Weintraub, who is an assistant professor at NYU Grossman School of Medicine.
Hair loss caused by rapid weight loss could be caused by an antiobesity medication, but it could also occur with other obesity treatments, such as bariatric surgery or drastic dietary changes, he said. The hair shedding is typically short lived and reversible.
About 80%-85% of hair is in the anagen (growth) phase, about 5% is in a transitional (catagen) phase, and the rest is in telogen (resting, or shedding) phase, Dr. Massick explained. In telogen effluvium, hairs that are normally in the growth phase get suddenly shifted to telogen phase and are shed rapidly.
“Telogen effluvium can be caused by rapid weight loss, major surgery, severe COVID infection, high fever, or death in the family,” she noted. “You will not go bald with telogen effluvium, but you might find that you may lose a good volume of hair,” much more than the normal loss of up to 100 hairs a day.
“I counsel my patients about the possibility of losing hair before they undergo bariatric surgery,” Dr. Saunders said. “Generally, the health benefits of weight loss and weight maintenance outweigh the risk of temporary hair loss.”
Nutritional deficiencies and malnutrition can contribute to hair loss as well, and iron deficiency is sometimes a culprit, she added.
“If someone is worried” about hair loss associated with weight loss, “they should see their doctor,” Dr. Peters said. “If they are on thyroid hormone, in particular, the levels should be retested after weight loss.”
Hair loss appears more common after bariatric surgery than with antiobesity medications,” Dr. Weintraub observed, and it is unclear whether this is because the weight loss is more dramatic after surgery and thus a greater stressor, or whether it is caused by nutrient deficiency or a different mechanism entirely.
“Unlike certain forms of bariatric surgery, which can lead to malabsorption (e.g., Roux-en-Y gastric bypass), medications such as GLP-1 agonists and GLP-1/GIP dual agonists do not cause malabsorption,” Dr. Weintraub noted. “So nutritional deficiencies are less likely to be the cause of new hair loss in those taking antiobesity medications than [in] someone who underwent bariatric surgery.”
Iron and vitamin D deficiencies are the most common nutritional deficiencies that can cause hair loss, he noted.
Slow and steady weight loss rather than rapid
“I would suggest that patients try to keep the weight loss slow and steady, rather than rapid,” Dr. Goldberg said, “and follow any vitamin/mineral supplementation plan that they are given. Patients with bariatric surgery have nutritional guidance and a supplementation plan.”
“Follow a well-balanced dietary strategy with ample protein, vegetables, and some fruit,” Dr. Saunders said. Health care providers should monitor lab tests to check for and treat vitamin deficiencies, and registered dietitians can be crucial to ensure proper nutrition. She advises patients: “Find coping strategies to reduce stress and get enough sleep. If iron levels are low, start an iron supplement under your provider’s supervision.”
“Some of my patients swear by biotin supplements, prenatal vitamins or ‘hair, skin, and nails’ vitamins,” she added. If hair loss doesn’t stop, a dermatologist can look for other contributors and discuss strategies for hair restoration.
Individuals who undergo bariatric surgery require lifelong vitamin supplementation and yearly (or more frequent) lab testing, she noted.
“With, for example, bariatric surgery or any type of diet change you want to make sure you still maintain a balanced diet, whether its calories, protein, iron, zinc, vitamins (vitamin D for example),” Dr. Massick echoed.
Similarly, Dr. Peters advised: “I would say to maintain a normal healthy diet even if eating less. Exercise. Do all those healthy things. Taking a daily multivitamin isn’t a bad idea. Talk with a nutritionist. Use the appetite suppression of the medication to combine with healthy eating.”
“If someone is having new hair loss, they should see their clinician to evaluate for all possible causes,” Dr. Weintraub said. “Their provider can evaluate for underlying causes like thyroid dysfunction, iron deficiency, and vitamin D deficiency.”
However, if a patient’s pattern of hair loss is not diffuse but occurs in patches, this has an entirely different set of etiologies probably unrelated to antiobesity medication and should be evaluated.
Working with a nutritionist to ensure that patients have sufficient protein and micronutrient intake can lower the risk of developing hair loss and other complications, Dr. Weintraub said. “This is particularly important for certain forms of bariatric surgery such as Roux-en-Y gastric bypass, since that can lead to malabsorption of specific vitamins and minerals that need to be periodically measured and supplemented.”
In individuals starting an antiobesity medication, beginning a daily multivitamin has little harm, he added, and can ensure they are getting essential minerals and vitamins. However, no studies have specifically investigated this yet.
“Ultimately, it’s important to weigh the benefits of antiobesity medications against the potential risks, as we do with any medical intervention,” according to Dr. Weintraub.
“The purpose of treating obesity,” he stressed, “is to reduce the risk of heart disease, stroke, and multiple types of cancers. It’s up to the individual to weigh these benefits against the risks of the treatment, including the low risk of developing temporary hair loss.”
Dr. Peters writes a column for Medscape and disclosed that she served as a consultant for Blue Circle Health, Vertex, and Abbott Diabetes Care; received a research grant from Abbott Diabetes Care; and received stock options from Teladoc and Omada Health. Dr. Goldberg, Dr. Saunders, Dr. Massick, and Dr. Weintraub declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Tweaking food delivery apps can lower calories purchased
DUBLIN – , show three new randomized trials from the United Kingdom.
The prominent positioning of low-calorie menu items, and restaurants with low-calorie main meals, on a food app emerged as the most promising approach to promote healthier eating, followed by preselecting smaller portions by default, and finally calorie labels, Anna Keleher, MPA, a behavioral scientist at Nesta, London, reported at the European Congress on Obesity (ECO) meeting.
“Many out-of-home meals have more calories than meals cooked in-home and using delivery apps is linked with a higher risk of becoming overweight or obese,” she remarked. “We’re interested in understanding more about delivery apps because they can be modified at scale easily and can reach millions of people with interventions to promote healthier and more nutritious options in these settings.”
Food delivery apps have surged in use in the United Kingdom with a 55% increase since 2015; examples include Uber Eats, Just Eat, and Deliveroo. “This trend is similar in the United States, with more and more consumers using delivery apps to buy food,” said Ms. Keleher, a senior adviser at the Behavioral Insights Team, New York.
Emma Boyland, PhD, an obesity psychologist from Liverpool (England) University, said: “Apps are an increasingly popular way for people to buy food and the virtual food environment is becoming as prominent as the physical food environment in how we go about obtaining meals.”
She highlighted the need to understand more about how food apps change the way we purchase and eat, but noted that “the work presented today” showed that “moving the position of food choices and information, as well as the brand name and imagery, influences what people end up buying and consuming.
“I think there’s a place for interventions that challenge these things and improve dietary health,” said Dr. Boyland, who chaired the session during which Ms. Keleher presented her results. “However, as we’ve seen with calorie labeling, they don’t always have the biggest effect on their own, so as is often the case, we need to take multiple actions, incorporating all the elements of the environment to make a meaningful difference.”
Three trials changing displays on simulated food delivery apps
“Delivery apps could reach millions of people and help us select healthier food options, and yet there is very little research looking at what works to promote healthier and more nutritious options in these settings,” Filippo Bianchi, MD, a colleague working with Ms. Keleher, said in a press release issued by ECO.
So the research team carried out a proof-of-concept testing of health-promoting interventions by developing a simulated food delivery app and asking 23,783 adults who typically use such services to choose a meal for themselves as if it were a real-life food delivery order.
“As a first step, we developed a simulated online food delivery platform to generate evidence on the effectiveness of our interventions,” Ms. Keleher explained, noting that the simulated platform included 21 restaurants and almost 600 food and drink items to choose from.
The research evaluated 14 interventions across three randomized controlled trials, displaying various food-ordering options that promoted lower-calorie options against a control. The trials investigated default choices (promoting the selection of small portion sizes through defaults, n = 6,000); positioning (promoting the selection of less calorie-dense options through positioning, n = 9,003); and labeling (promoting the selection of less calorific options through calorie labels, n = 8,780).
The primary outcome was the total number of calories in the basket at checkout. The results were adjusted for potentially confounding factors, such as body mass index, age, gender, and income.
For the trial that promoted smaller portions by default, “all of our interventions significantly reduced calorie purchases, with each additional intervention element increasing the effect sizes, which ranged from a 6% to 13% reduction in calories [–5.5% to –12.5% kcal/order; P < .05],” reported Ms. Keleher.
The second trial varied the position of both items on the menu and the order of restaurants – effectively, lower-calorie menu options were more prominent, and restaurant options with lower-calorie main meals were placed at the top of the restaurant selection page.
Ms. Keleher noted that there have been some concerns about whether this strategy would negatively affect restaurant business, so the research team counteracted this by also incorporating an option where low-calorie but high-price options were placed near the top of the display to promote healthier options but without loss of income for participating restaurants. This last intervention with low-calorie/high-price options placed near the top also led to reduced calorie intake.
“This showed that promoting low-calorie options does not necessarily mean damaging business revenue,” she said. “We hope that the industry can evolve to meet the widely recognized needs of society and consumers.”
Repositioning restaurants emerged as more effective than repositioning foods on the menu, while all interventions significantly reduced calorie purchases. “Effect sizes ranged from 6% to 15% reductions in calories purchased per order [P < .05],” reported Ms. Keleher.
The last trial tested seven calorie labels: four that changed the font size and location of the label, two that added a switch on/off filter for calorie label display, and one that was a calorie summary at checkout.
“All these standard calorie labels directionally reduced the number of excess calories with two [options] reaching statistical significance. Five out of seven labels significantly reduced calorie purchases with effect sizes ranging from 4.3% to –7.8% kcal/order (P < .05),” reported Ms. Keleher.
“This research is important for policymakers so they can understand the best way for companies to display calorie labels and what to include in regulations and guidelines,” she summarized.
Qualitative think-aloud study explored views around food delivery apps
Another piece of research, the think-aloud study, by the same authors, was presented at ECO, and explored how best to enhance the effectiveness and acceptability of calorie labels in food delivery apps in consultation with 20 adult delivery app users in the United Kingdom.
Researchers tried to document the range of views people have about calorie labels, including variation both between people and within an individual.
“For example, on a weekend, people might not want to engage with calories at all because they are more concerned to treat themselves, whereas at a mid-week lunch that same person might really want the ability to check the calorie content of their food,” Ms. Keleher reported.
She said that considerations varied significantly between people such that they described different ways in which calorie labeling impacted their food-ordering experience.
“Some people felt labels supported their existing intentions, whereas others felt labels built their knowledge. Still others felt calorie labels were insufficient to support their health and wanted more information, such as on macronutrients,” said Ms. Keleher, quoting one participant: “There’s no situation in which I would look at [calories]. I look at nutrients. I prefer the traffic light system [color-coding salt, fat, and sugar content],” she relayed.
The key recommendations based on the think-aloud study included providing a filter that allows users to switch calorie labels on and off; communicating recommended energy intake per meal (that is, 600 kcal) and not just per day (that is, 2,000 kcal); and avoiding framing calorie label messaging or formatting as judgmental (for example, red fonts).
“These studies provide encouraging proof-of-concept evidence that small tweaks in delivery apps could help many people to identify and select healthier foods. Testing similar initiatives with real restaurants and delivery apps will be important to assess the long-term impact of these interventions in the real world. Further research should also explore the best way to balance desired health impacts while minimizing effects on businesses and on cost-of-living concerns for consumers,” concluded Dr. Bianchi.
A version of this article first appeared on Medscape.com.
DUBLIN – , show three new randomized trials from the United Kingdom.
The prominent positioning of low-calorie menu items, and restaurants with low-calorie main meals, on a food app emerged as the most promising approach to promote healthier eating, followed by preselecting smaller portions by default, and finally calorie labels, Anna Keleher, MPA, a behavioral scientist at Nesta, London, reported at the European Congress on Obesity (ECO) meeting.
“Many out-of-home meals have more calories than meals cooked in-home and using delivery apps is linked with a higher risk of becoming overweight or obese,” she remarked. “We’re interested in understanding more about delivery apps because they can be modified at scale easily and can reach millions of people with interventions to promote healthier and more nutritious options in these settings.”
Food delivery apps have surged in use in the United Kingdom with a 55% increase since 2015; examples include Uber Eats, Just Eat, and Deliveroo. “This trend is similar in the United States, with more and more consumers using delivery apps to buy food,” said Ms. Keleher, a senior adviser at the Behavioral Insights Team, New York.
Emma Boyland, PhD, an obesity psychologist from Liverpool (England) University, said: “Apps are an increasingly popular way for people to buy food and the virtual food environment is becoming as prominent as the physical food environment in how we go about obtaining meals.”
She highlighted the need to understand more about how food apps change the way we purchase and eat, but noted that “the work presented today” showed that “moving the position of food choices and information, as well as the brand name and imagery, influences what people end up buying and consuming.
“I think there’s a place for interventions that challenge these things and improve dietary health,” said Dr. Boyland, who chaired the session during which Ms. Keleher presented her results. “However, as we’ve seen with calorie labeling, they don’t always have the biggest effect on their own, so as is often the case, we need to take multiple actions, incorporating all the elements of the environment to make a meaningful difference.”
Three trials changing displays on simulated food delivery apps
“Delivery apps could reach millions of people and help us select healthier food options, and yet there is very little research looking at what works to promote healthier and more nutritious options in these settings,” Filippo Bianchi, MD, a colleague working with Ms. Keleher, said in a press release issued by ECO.
So the research team carried out a proof-of-concept testing of health-promoting interventions by developing a simulated food delivery app and asking 23,783 adults who typically use such services to choose a meal for themselves as if it were a real-life food delivery order.
“As a first step, we developed a simulated online food delivery platform to generate evidence on the effectiveness of our interventions,” Ms. Keleher explained, noting that the simulated platform included 21 restaurants and almost 600 food and drink items to choose from.
The research evaluated 14 interventions across three randomized controlled trials, displaying various food-ordering options that promoted lower-calorie options against a control. The trials investigated default choices (promoting the selection of small portion sizes through defaults, n = 6,000); positioning (promoting the selection of less calorie-dense options through positioning, n = 9,003); and labeling (promoting the selection of less calorific options through calorie labels, n = 8,780).
The primary outcome was the total number of calories in the basket at checkout. The results were adjusted for potentially confounding factors, such as body mass index, age, gender, and income.
For the trial that promoted smaller portions by default, “all of our interventions significantly reduced calorie purchases, with each additional intervention element increasing the effect sizes, which ranged from a 6% to 13% reduction in calories [–5.5% to –12.5% kcal/order; P < .05],” reported Ms. Keleher.
The second trial varied the position of both items on the menu and the order of restaurants – effectively, lower-calorie menu options were more prominent, and restaurant options with lower-calorie main meals were placed at the top of the restaurant selection page.
Ms. Keleher noted that there have been some concerns about whether this strategy would negatively affect restaurant business, so the research team counteracted this by also incorporating an option where low-calorie but high-price options were placed near the top of the display to promote healthier options but without loss of income for participating restaurants. This last intervention with low-calorie/high-price options placed near the top also led to reduced calorie intake.
“This showed that promoting low-calorie options does not necessarily mean damaging business revenue,” she said. “We hope that the industry can evolve to meet the widely recognized needs of society and consumers.”
Repositioning restaurants emerged as more effective than repositioning foods on the menu, while all interventions significantly reduced calorie purchases. “Effect sizes ranged from 6% to 15% reductions in calories purchased per order [P < .05],” reported Ms. Keleher.
The last trial tested seven calorie labels: four that changed the font size and location of the label, two that added a switch on/off filter for calorie label display, and one that was a calorie summary at checkout.
“All these standard calorie labels directionally reduced the number of excess calories with two [options] reaching statistical significance. Five out of seven labels significantly reduced calorie purchases with effect sizes ranging from 4.3% to –7.8% kcal/order (P < .05),” reported Ms. Keleher.
“This research is important for policymakers so they can understand the best way for companies to display calorie labels and what to include in regulations and guidelines,” she summarized.
Qualitative think-aloud study explored views around food delivery apps
Another piece of research, the think-aloud study, by the same authors, was presented at ECO, and explored how best to enhance the effectiveness and acceptability of calorie labels in food delivery apps in consultation with 20 adult delivery app users in the United Kingdom.
Researchers tried to document the range of views people have about calorie labels, including variation both between people and within an individual.
“For example, on a weekend, people might not want to engage with calories at all because they are more concerned to treat themselves, whereas at a mid-week lunch that same person might really want the ability to check the calorie content of their food,” Ms. Keleher reported.
She said that considerations varied significantly between people such that they described different ways in which calorie labeling impacted their food-ordering experience.
“Some people felt labels supported their existing intentions, whereas others felt labels built their knowledge. Still others felt calorie labels were insufficient to support their health and wanted more information, such as on macronutrients,” said Ms. Keleher, quoting one participant: “There’s no situation in which I would look at [calories]. I look at nutrients. I prefer the traffic light system [color-coding salt, fat, and sugar content],” she relayed.
The key recommendations based on the think-aloud study included providing a filter that allows users to switch calorie labels on and off; communicating recommended energy intake per meal (that is, 600 kcal) and not just per day (that is, 2,000 kcal); and avoiding framing calorie label messaging or formatting as judgmental (for example, red fonts).
“These studies provide encouraging proof-of-concept evidence that small tweaks in delivery apps could help many people to identify and select healthier foods. Testing similar initiatives with real restaurants and delivery apps will be important to assess the long-term impact of these interventions in the real world. Further research should also explore the best way to balance desired health impacts while minimizing effects on businesses and on cost-of-living concerns for consumers,” concluded Dr. Bianchi.
A version of this article first appeared on Medscape.com.
DUBLIN – , show three new randomized trials from the United Kingdom.
The prominent positioning of low-calorie menu items, and restaurants with low-calorie main meals, on a food app emerged as the most promising approach to promote healthier eating, followed by preselecting smaller portions by default, and finally calorie labels, Anna Keleher, MPA, a behavioral scientist at Nesta, London, reported at the European Congress on Obesity (ECO) meeting.
“Many out-of-home meals have more calories than meals cooked in-home and using delivery apps is linked with a higher risk of becoming overweight or obese,” she remarked. “We’re interested in understanding more about delivery apps because they can be modified at scale easily and can reach millions of people with interventions to promote healthier and more nutritious options in these settings.”
Food delivery apps have surged in use in the United Kingdom with a 55% increase since 2015; examples include Uber Eats, Just Eat, and Deliveroo. “This trend is similar in the United States, with more and more consumers using delivery apps to buy food,” said Ms. Keleher, a senior adviser at the Behavioral Insights Team, New York.
Emma Boyland, PhD, an obesity psychologist from Liverpool (England) University, said: “Apps are an increasingly popular way for people to buy food and the virtual food environment is becoming as prominent as the physical food environment in how we go about obtaining meals.”
She highlighted the need to understand more about how food apps change the way we purchase and eat, but noted that “the work presented today” showed that “moving the position of food choices and information, as well as the brand name and imagery, influences what people end up buying and consuming.
“I think there’s a place for interventions that challenge these things and improve dietary health,” said Dr. Boyland, who chaired the session during which Ms. Keleher presented her results. “However, as we’ve seen with calorie labeling, they don’t always have the biggest effect on their own, so as is often the case, we need to take multiple actions, incorporating all the elements of the environment to make a meaningful difference.”
Three trials changing displays on simulated food delivery apps
“Delivery apps could reach millions of people and help us select healthier food options, and yet there is very little research looking at what works to promote healthier and more nutritious options in these settings,” Filippo Bianchi, MD, a colleague working with Ms. Keleher, said in a press release issued by ECO.
So the research team carried out a proof-of-concept testing of health-promoting interventions by developing a simulated food delivery app and asking 23,783 adults who typically use such services to choose a meal for themselves as if it were a real-life food delivery order.
“As a first step, we developed a simulated online food delivery platform to generate evidence on the effectiveness of our interventions,” Ms. Keleher explained, noting that the simulated platform included 21 restaurants and almost 600 food and drink items to choose from.
The research evaluated 14 interventions across three randomized controlled trials, displaying various food-ordering options that promoted lower-calorie options against a control. The trials investigated default choices (promoting the selection of small portion sizes through defaults, n = 6,000); positioning (promoting the selection of less calorie-dense options through positioning, n = 9,003); and labeling (promoting the selection of less calorific options through calorie labels, n = 8,780).
The primary outcome was the total number of calories in the basket at checkout. The results were adjusted for potentially confounding factors, such as body mass index, age, gender, and income.
For the trial that promoted smaller portions by default, “all of our interventions significantly reduced calorie purchases, with each additional intervention element increasing the effect sizes, which ranged from a 6% to 13% reduction in calories [–5.5% to –12.5% kcal/order; P < .05],” reported Ms. Keleher.
The second trial varied the position of both items on the menu and the order of restaurants – effectively, lower-calorie menu options were more prominent, and restaurant options with lower-calorie main meals were placed at the top of the restaurant selection page.
Ms. Keleher noted that there have been some concerns about whether this strategy would negatively affect restaurant business, so the research team counteracted this by also incorporating an option where low-calorie but high-price options were placed near the top of the display to promote healthier options but without loss of income for participating restaurants. This last intervention with low-calorie/high-price options placed near the top also led to reduced calorie intake.
“This showed that promoting low-calorie options does not necessarily mean damaging business revenue,” she said. “We hope that the industry can evolve to meet the widely recognized needs of society and consumers.”
Repositioning restaurants emerged as more effective than repositioning foods on the menu, while all interventions significantly reduced calorie purchases. “Effect sizes ranged from 6% to 15% reductions in calories purchased per order [P < .05],” reported Ms. Keleher.
The last trial tested seven calorie labels: four that changed the font size and location of the label, two that added a switch on/off filter for calorie label display, and one that was a calorie summary at checkout.
“All these standard calorie labels directionally reduced the number of excess calories with two [options] reaching statistical significance. Five out of seven labels significantly reduced calorie purchases with effect sizes ranging from 4.3% to –7.8% kcal/order (P < .05),” reported Ms. Keleher.
“This research is important for policymakers so they can understand the best way for companies to display calorie labels and what to include in regulations and guidelines,” she summarized.
Qualitative think-aloud study explored views around food delivery apps
Another piece of research, the think-aloud study, by the same authors, was presented at ECO, and explored how best to enhance the effectiveness and acceptability of calorie labels in food delivery apps in consultation with 20 adult delivery app users in the United Kingdom.
Researchers tried to document the range of views people have about calorie labels, including variation both between people and within an individual.
“For example, on a weekend, people might not want to engage with calories at all because they are more concerned to treat themselves, whereas at a mid-week lunch that same person might really want the ability to check the calorie content of their food,” Ms. Keleher reported.
She said that considerations varied significantly between people such that they described different ways in which calorie labeling impacted their food-ordering experience.
“Some people felt labels supported their existing intentions, whereas others felt labels built their knowledge. Still others felt calorie labels were insufficient to support their health and wanted more information, such as on macronutrients,” said Ms. Keleher, quoting one participant: “There’s no situation in which I would look at [calories]. I look at nutrients. I prefer the traffic light system [color-coding salt, fat, and sugar content],” she relayed.
The key recommendations based on the think-aloud study included providing a filter that allows users to switch calorie labels on and off; communicating recommended energy intake per meal (that is, 600 kcal) and not just per day (that is, 2,000 kcal); and avoiding framing calorie label messaging or formatting as judgmental (for example, red fonts).
“These studies provide encouraging proof-of-concept evidence that small tweaks in delivery apps could help many people to identify and select healthier foods. Testing similar initiatives with real restaurants and delivery apps will be important to assess the long-term impact of these interventions in the real world. Further research should also explore the best way to balance desired health impacts while minimizing effects on businesses and on cost-of-living concerns for consumers,” concluded Dr. Bianchi.
A version of this article first appeared on Medscape.com.
AT ECO 2023
Eating disorders in children is a global public health emergency
The high figures are concerning from a public health perspective and highlight the need to implement strategies for preventing eating disorders.
These disorders include anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorder–not otherwise specified. The prevalence of these disorders in young people has markedly increased globally over the past 50 years. Eating disorders are among the most life-threatening mental disorders; they were responsible for 318 deaths worldwide in 2019.
Because some individuals with eating disorders conceal core symptoms and avoid or delay seeking specialist care because of feelings of embarrassment, stigma, or ambivalence toward treatment, most cases of eating disorders remain undetected and untreated.
Brazilian researchers conducted studies to assess risky behaviors and predisposing factors among young people. The researchers observed that the probability of experiencing eating disorders was higher among young people who had an intense fear of gaining weight, who experienced thin-ideal internalization, who were excessively concerned about food, who experienced compulsive eating episodes, or who used laxatives. As previously reported, most participants in these studies had never sought professional help.
A study conducted in 2020 concluded that the media greatly influences the construction of one’s body image and the creation of aesthetic standards, particularly for adolescents. Adolescents then change their eating patterns and become more vulnerable to mental disorders related to eating.
A group of researchers from several countries, including Brazilians connected to the State University of Londrina, conducted the Global Proportion of Disordered Eating in Children and Adolescents – A Systematic Review and Meta-analysis. The study was coordinated by José Francisco López-Gil, PhD, of the University of Castilla–La Mancha (Spain). The investigators determined the rate of disordered eating among children and adolescents using the SCOFF (Sick, Control, One, Fat, Food) questionnaire, which is the most widely used screening measure for eating disorders.
Methods and results
Four databases were systematically searched (PubMed, Scopus, Web of Science, and the Cochrane Library); date limits were from January 1999 to November 2022. Studies were required to meet the following criteria: participants – studies of community samples of children and adolescents aged 6-18 years – and outcome – disordered eating assessed by the SCOFF questionnaire. The exclusion criteria were studies conducted with young people who had been diagnosed with physical or mental disorders; studies that were published before 1999, because the SCOFF questionnaire was designed in that year; studies in which data were collected during the COVID-19 pandemic, because of the possibility of selection bias; studies that employed data from the same surveys/studies, to avoid duplication; and systematic reviews and/or meta-analyses and qualitative and case studies.
In all, 32 studies, which involved a total of 63,181 participants from 16 countries, were included in the systematic review and meta-analysis, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The overall proportion of children and adolescents with disordered eating was 22.36% (95% confidence interval, 18.84%-26.09%; P < .001; n = 63,181). According to the researchers, girls were significantly more likely to report disordered eating (30.03%; 95% CI, 25.61%-34.65%; n = 27,548) than boys (16.98%; 95% CI, 13.46%-20.81%; n = 26,170; P < .001). It was also observed that disordered eating became more elevated with increasing age (B, 0.03; 95% CI, 0-0.06; P = .049) and BMI (B, 0.03; 95% CI, 0.01-0.05; P < .001).
Translation of outcomes
According to the authors, this was the first meta-analysis that comprehensively examined the overall proportion of children and adolescents with disordered eating in terms of gender, mean age, and BMI. They identified 14,856 (22.36%) children and adolescents with disordered eating in the population analyzed (n = 63,181). A relevant consideration made by the researchers is that, in general, disordered eating and eating disorders are not similar. “Not all children and adolescents who reported disordered eating behaviors (for example, selective eating) will necessarily be diagnosed with an eating disorder.” However, disordered eating in childhood or adolescence may predict outcomes associated with eating disorders in early adulthood. “For this reason, this high proportion found is worrisome and calls for urgent action to try to address this situation.”
The study also found that the proportion of children and adolescents with disordered eating was higher among girls than boys. The reasons for the difference in the prevalence with respect to the sex of the participants are not well understood. Boys are presumed to underreport the problem because of the societal perception that these disorders mostly affect girls and because disordered eating has usually been thought by the general population to be exclusive to girls and women. In addition, it has been noted that the current diagnostic criteria for eating disorders fail to detect disordered eating behaviors more commonly observed in boys than girls, such as intensely engaging in muscle mass gain and weight gain with the goal of improving body image satisfaction. On the other hand, the proportion of young people with disordered eating increased with increasing age and BMI. This finding is in line with the scientific literature worldwide.
The study has certain limitations. First, only studies that analyzed disordered eating using the SCOFF questionnaire were included. Second, because of the cross-sectional nature of most of the included studies, a causal relationship cannot be established. Third, owing to the inclusion of binge eating disorder and other eating disorders specified in the DSM-5, there is not enough evidence to support the use of SCOFF in primary care and community-based settings for screening for the range of eating disorders. Fourth, the meta-analysis included studies in which self-report questionnaires were used to assess disordered eating, and consequently, social desirability and recall bias could have influenced the findings.
Quick measures required
Identifying the magnitude of disordered eating and its distribution in at-risk populations is crucial for planning and executing actions aimed at preventing, detecting, and treating them. Eating disorders are a global public health problem that health care professionals, families, and other community members involved in caring for children and adolescents must not ignore, the researchers said. In addition to diagnosed eating disorders, parents, guardians, and health care professionals should be aware of symptoms of disordered eating, which include behaviors such as weight-loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics without medical prescription.
This article was translated from the Medscape Portuguese Edition. A version of this article appeared on Medscape.com.
The high figures are concerning from a public health perspective and highlight the need to implement strategies for preventing eating disorders.
These disorders include anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorder–not otherwise specified. The prevalence of these disorders in young people has markedly increased globally over the past 50 years. Eating disorders are among the most life-threatening mental disorders; they were responsible for 318 deaths worldwide in 2019.
Because some individuals with eating disorders conceal core symptoms and avoid or delay seeking specialist care because of feelings of embarrassment, stigma, or ambivalence toward treatment, most cases of eating disorders remain undetected and untreated.
Brazilian researchers conducted studies to assess risky behaviors and predisposing factors among young people. The researchers observed that the probability of experiencing eating disorders was higher among young people who had an intense fear of gaining weight, who experienced thin-ideal internalization, who were excessively concerned about food, who experienced compulsive eating episodes, or who used laxatives. As previously reported, most participants in these studies had never sought professional help.
A study conducted in 2020 concluded that the media greatly influences the construction of one’s body image and the creation of aesthetic standards, particularly for adolescents. Adolescents then change their eating patterns and become more vulnerable to mental disorders related to eating.
A group of researchers from several countries, including Brazilians connected to the State University of Londrina, conducted the Global Proportion of Disordered Eating in Children and Adolescents – A Systematic Review and Meta-analysis. The study was coordinated by José Francisco López-Gil, PhD, of the University of Castilla–La Mancha (Spain). The investigators determined the rate of disordered eating among children and adolescents using the SCOFF (Sick, Control, One, Fat, Food) questionnaire, which is the most widely used screening measure for eating disorders.
Methods and results
Four databases were systematically searched (PubMed, Scopus, Web of Science, and the Cochrane Library); date limits were from January 1999 to November 2022. Studies were required to meet the following criteria: participants – studies of community samples of children and adolescents aged 6-18 years – and outcome – disordered eating assessed by the SCOFF questionnaire. The exclusion criteria were studies conducted with young people who had been diagnosed with physical or mental disorders; studies that were published before 1999, because the SCOFF questionnaire was designed in that year; studies in which data were collected during the COVID-19 pandemic, because of the possibility of selection bias; studies that employed data from the same surveys/studies, to avoid duplication; and systematic reviews and/or meta-analyses and qualitative and case studies.
In all, 32 studies, which involved a total of 63,181 participants from 16 countries, were included in the systematic review and meta-analysis, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The overall proportion of children and adolescents with disordered eating was 22.36% (95% confidence interval, 18.84%-26.09%; P < .001; n = 63,181). According to the researchers, girls were significantly more likely to report disordered eating (30.03%; 95% CI, 25.61%-34.65%; n = 27,548) than boys (16.98%; 95% CI, 13.46%-20.81%; n = 26,170; P < .001). It was also observed that disordered eating became more elevated with increasing age (B, 0.03; 95% CI, 0-0.06; P = .049) and BMI (B, 0.03; 95% CI, 0.01-0.05; P < .001).
Translation of outcomes
According to the authors, this was the first meta-analysis that comprehensively examined the overall proportion of children and adolescents with disordered eating in terms of gender, mean age, and BMI. They identified 14,856 (22.36%) children and adolescents with disordered eating in the population analyzed (n = 63,181). A relevant consideration made by the researchers is that, in general, disordered eating and eating disorders are not similar. “Not all children and adolescents who reported disordered eating behaviors (for example, selective eating) will necessarily be diagnosed with an eating disorder.” However, disordered eating in childhood or adolescence may predict outcomes associated with eating disorders in early adulthood. “For this reason, this high proportion found is worrisome and calls for urgent action to try to address this situation.”
The study also found that the proportion of children and adolescents with disordered eating was higher among girls than boys. The reasons for the difference in the prevalence with respect to the sex of the participants are not well understood. Boys are presumed to underreport the problem because of the societal perception that these disorders mostly affect girls and because disordered eating has usually been thought by the general population to be exclusive to girls and women. In addition, it has been noted that the current diagnostic criteria for eating disorders fail to detect disordered eating behaviors more commonly observed in boys than girls, such as intensely engaging in muscle mass gain and weight gain with the goal of improving body image satisfaction. On the other hand, the proportion of young people with disordered eating increased with increasing age and BMI. This finding is in line with the scientific literature worldwide.
The study has certain limitations. First, only studies that analyzed disordered eating using the SCOFF questionnaire were included. Second, because of the cross-sectional nature of most of the included studies, a causal relationship cannot be established. Third, owing to the inclusion of binge eating disorder and other eating disorders specified in the DSM-5, there is not enough evidence to support the use of SCOFF in primary care and community-based settings for screening for the range of eating disorders. Fourth, the meta-analysis included studies in which self-report questionnaires were used to assess disordered eating, and consequently, social desirability and recall bias could have influenced the findings.
Quick measures required
Identifying the magnitude of disordered eating and its distribution in at-risk populations is crucial for planning and executing actions aimed at preventing, detecting, and treating them. Eating disorders are a global public health problem that health care professionals, families, and other community members involved in caring for children and adolescents must not ignore, the researchers said. In addition to diagnosed eating disorders, parents, guardians, and health care professionals should be aware of symptoms of disordered eating, which include behaviors such as weight-loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics without medical prescription.
This article was translated from the Medscape Portuguese Edition. A version of this article appeared on Medscape.com.
The high figures are concerning from a public health perspective and highlight the need to implement strategies for preventing eating disorders.
These disorders include anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorder–not otherwise specified. The prevalence of these disorders in young people has markedly increased globally over the past 50 years. Eating disorders are among the most life-threatening mental disorders; they were responsible for 318 deaths worldwide in 2019.
Because some individuals with eating disorders conceal core symptoms and avoid or delay seeking specialist care because of feelings of embarrassment, stigma, or ambivalence toward treatment, most cases of eating disorders remain undetected and untreated.
Brazilian researchers conducted studies to assess risky behaviors and predisposing factors among young people. The researchers observed that the probability of experiencing eating disorders was higher among young people who had an intense fear of gaining weight, who experienced thin-ideal internalization, who were excessively concerned about food, who experienced compulsive eating episodes, or who used laxatives. As previously reported, most participants in these studies had never sought professional help.
A study conducted in 2020 concluded that the media greatly influences the construction of one’s body image and the creation of aesthetic standards, particularly for adolescents. Adolescents then change their eating patterns and become more vulnerable to mental disorders related to eating.
A group of researchers from several countries, including Brazilians connected to the State University of Londrina, conducted the Global Proportion of Disordered Eating in Children and Adolescents – A Systematic Review and Meta-analysis. The study was coordinated by José Francisco López-Gil, PhD, of the University of Castilla–La Mancha (Spain). The investigators determined the rate of disordered eating among children and adolescents using the SCOFF (Sick, Control, One, Fat, Food) questionnaire, which is the most widely used screening measure for eating disorders.
Methods and results
Four databases were systematically searched (PubMed, Scopus, Web of Science, and the Cochrane Library); date limits were from January 1999 to November 2022. Studies were required to meet the following criteria: participants – studies of community samples of children and adolescents aged 6-18 years – and outcome – disordered eating assessed by the SCOFF questionnaire. The exclusion criteria were studies conducted with young people who had been diagnosed with physical or mental disorders; studies that were published before 1999, because the SCOFF questionnaire was designed in that year; studies in which data were collected during the COVID-19 pandemic, because of the possibility of selection bias; studies that employed data from the same surveys/studies, to avoid duplication; and systematic reviews and/or meta-analyses and qualitative and case studies.
In all, 32 studies, which involved a total of 63,181 participants from 16 countries, were included in the systematic review and meta-analysis, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The overall proportion of children and adolescents with disordered eating was 22.36% (95% confidence interval, 18.84%-26.09%; P < .001; n = 63,181). According to the researchers, girls were significantly more likely to report disordered eating (30.03%; 95% CI, 25.61%-34.65%; n = 27,548) than boys (16.98%; 95% CI, 13.46%-20.81%; n = 26,170; P < .001). It was also observed that disordered eating became more elevated with increasing age (B, 0.03; 95% CI, 0-0.06; P = .049) and BMI (B, 0.03; 95% CI, 0.01-0.05; P < .001).
Translation of outcomes
According to the authors, this was the first meta-analysis that comprehensively examined the overall proportion of children and adolescents with disordered eating in terms of gender, mean age, and BMI. They identified 14,856 (22.36%) children and adolescents with disordered eating in the population analyzed (n = 63,181). A relevant consideration made by the researchers is that, in general, disordered eating and eating disorders are not similar. “Not all children and adolescents who reported disordered eating behaviors (for example, selective eating) will necessarily be diagnosed with an eating disorder.” However, disordered eating in childhood or adolescence may predict outcomes associated with eating disorders in early adulthood. “For this reason, this high proportion found is worrisome and calls for urgent action to try to address this situation.”
The study also found that the proportion of children and adolescents with disordered eating was higher among girls than boys. The reasons for the difference in the prevalence with respect to the sex of the participants are not well understood. Boys are presumed to underreport the problem because of the societal perception that these disorders mostly affect girls and because disordered eating has usually been thought by the general population to be exclusive to girls and women. In addition, it has been noted that the current diagnostic criteria for eating disorders fail to detect disordered eating behaviors more commonly observed in boys than girls, such as intensely engaging in muscle mass gain and weight gain with the goal of improving body image satisfaction. On the other hand, the proportion of young people with disordered eating increased with increasing age and BMI. This finding is in line with the scientific literature worldwide.
The study has certain limitations. First, only studies that analyzed disordered eating using the SCOFF questionnaire were included. Second, because of the cross-sectional nature of most of the included studies, a causal relationship cannot be established. Third, owing to the inclusion of binge eating disorder and other eating disorders specified in the DSM-5, there is not enough evidence to support the use of SCOFF in primary care and community-based settings for screening for the range of eating disorders. Fourth, the meta-analysis included studies in which self-report questionnaires were used to assess disordered eating, and consequently, social desirability and recall bias could have influenced the findings.
Quick measures required
Identifying the magnitude of disordered eating and its distribution in at-risk populations is crucial for planning and executing actions aimed at preventing, detecting, and treating them. Eating disorders are a global public health problem that health care professionals, families, and other community members involved in caring for children and adolescents must not ignore, the researchers said. In addition to diagnosed eating disorders, parents, guardians, and health care professionals should be aware of symptoms of disordered eating, which include behaviors such as weight-loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics without medical prescription.
This article was translated from the Medscape Portuguese Edition. A version of this article appeared on Medscape.com.
FROM JAMA PEDIATRICS
‘Staggering’ weight loss and benefits in body composition with tirzepatide
DUBLIN – , according to the latest results of the SURMOUNT-1 study.
The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.
Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.
Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.
Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.
“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.
“This is staggering weight loss,” remarked Dr. Aronne. “To put it in perspective, mean weight loss in people having Lap-Band surgery is 17%, mean weight loss for sleeve gastrectomy is 25%, and gastric bypass is 33%, which puts the effects of tirzepatide squarely in the realm of bariatric surgery.”
“Something we have sought for decades, we have finally been able to achieve,” he asserted. “I still remember exactly where I was when I saw these results for the first time last April. I knew something big was happening,” declared Dr. Aronne when presenting the latest analyses at the 2023 European Congress on Obesity. Full study results were published in the New England Journal of Medicine.
Moderator Gabriella Lieberman, MD, endocrinologist and head of the Israeli Center for Weight Management, Sheba Medical Center, Ramat-Gan, Israel, welcomed the study but also expressed caution. “It’s very potent, but as we see generally with potent therapies, I think it will change how we look at nutritional advice and the role of the dietician will change. I’m a bit worried the drug is running fast and the support, which is crucial with these treatments, is not keeping up, and we’ll have to deal with some effects later, such as sarcopenia,” she pointed out in an interview.
“We have to treat these drugs as if they are bariatric surgery. I see patients on these types of drugs in clinic and their appetite is so suppressed that they think they can afford to eat things that are unhealthy because they lose weight, and that’s what they want. There has to be a responsible adult looking at what they’re eating, and not just clapping their hands for the weight loss, but ensuring they are not deprived of anything,” she said.
Weight loss and body composition explored
Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization.
The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m2 (class I, II, III obesity) or greater than or equal to 27 kg/m2 (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m2, and 94.5% of participants had BMI greater than or equal to 30 kg/m2.
Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m2, greater than or equal to 30 to less than 35 kg/m2 (class 1 obesity), greater than or equal to 35 to less than 40 kg/m2 (class 2 obesity), and greater than or equal to 40 kg/m2 (class 3 obesity).
In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).
The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).
The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.
By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category.
“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m2,” he explained. “It’s the higher BMI categories where we need the higher dose.”
As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.
“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”
Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported.
Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.
With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.
“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.
Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.
“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”
“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”
The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.
A version of this article first appeared on Medscape.com.
DUBLIN – , according to the latest results of the SURMOUNT-1 study.
The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.
Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.
Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.
Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.
“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.
“This is staggering weight loss,” remarked Dr. Aronne. “To put it in perspective, mean weight loss in people having Lap-Band surgery is 17%, mean weight loss for sleeve gastrectomy is 25%, and gastric bypass is 33%, which puts the effects of tirzepatide squarely in the realm of bariatric surgery.”
“Something we have sought for decades, we have finally been able to achieve,” he asserted. “I still remember exactly where I was when I saw these results for the first time last April. I knew something big was happening,” declared Dr. Aronne when presenting the latest analyses at the 2023 European Congress on Obesity. Full study results were published in the New England Journal of Medicine.
Moderator Gabriella Lieberman, MD, endocrinologist and head of the Israeli Center for Weight Management, Sheba Medical Center, Ramat-Gan, Israel, welcomed the study but also expressed caution. “It’s very potent, but as we see generally with potent therapies, I think it will change how we look at nutritional advice and the role of the dietician will change. I’m a bit worried the drug is running fast and the support, which is crucial with these treatments, is not keeping up, and we’ll have to deal with some effects later, such as sarcopenia,” she pointed out in an interview.
“We have to treat these drugs as if they are bariatric surgery. I see patients on these types of drugs in clinic and their appetite is so suppressed that they think they can afford to eat things that are unhealthy because they lose weight, and that’s what they want. There has to be a responsible adult looking at what they’re eating, and not just clapping their hands for the weight loss, but ensuring they are not deprived of anything,” she said.
Weight loss and body composition explored
Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization.
The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m2 (class I, II, III obesity) or greater than or equal to 27 kg/m2 (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m2, and 94.5% of participants had BMI greater than or equal to 30 kg/m2.
Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m2, greater than or equal to 30 to less than 35 kg/m2 (class 1 obesity), greater than or equal to 35 to less than 40 kg/m2 (class 2 obesity), and greater than or equal to 40 kg/m2 (class 3 obesity).
In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).
The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).
The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.
By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category.
“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m2,” he explained. “It’s the higher BMI categories where we need the higher dose.”
As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.
“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”
Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported.
Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.
With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.
“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.
Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.
“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”
“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”
The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.
A version of this article first appeared on Medscape.com.
DUBLIN – , according to the latest results of the SURMOUNT-1 study.
The new analysis showed that up to 63% of participants achieved a reduction in body weight of at least 20%, and all three tirzepatide doses (5 mg, 10 mg, and 15 mg) led to substantial, clinically meaningful, and sustained body-weight reduction, compared with placebo at 72 weeks of follow-up.
Mean weight loss was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for placebo (all P < .001 vs. placebo). And among participants taking the highest 15-mg dose of tirzepatide, 96%, 90%, and 78% of patients achieved weight reductions of at least 5%, 10%, and 15%.
Tirzepatide is approved in the United States and the European Union for the treatment of type 2 diabetes but is not yet approved for obesity in any country. The manufacturer of tirzepatide, Eli Lilly, intends to seek approval for the drug as an obesity treatment from the U.S. Food and Drug Administration, European Medicines Agency, and in other territories beginning in 2023.
Regardless of baseline BMI category, 9 out of 10 people achieved the greater than or equal to 5% body weight reduction threshold across all doses of tirzepatide, and at the higher doses, over one-third achieved weight loss of 25% or more.
“Similar to lifestyle and surgical treatments, participants on tirzepatide had around a threefold greater percent reduction in fat mass, compared with lean mass, resulting in an overall improvement in body composition,” reported SURMOUNT-1 co-investigator Louis Aronne, MD, Comprehensive Weight Control Center, Weill Cornell Medicine, New York.
“This is staggering weight loss,” remarked Dr. Aronne. “To put it in perspective, mean weight loss in people having Lap-Band surgery is 17%, mean weight loss for sleeve gastrectomy is 25%, and gastric bypass is 33%, which puts the effects of tirzepatide squarely in the realm of bariatric surgery.”
“Something we have sought for decades, we have finally been able to achieve,” he asserted. “I still remember exactly where I was when I saw these results for the first time last April. I knew something big was happening,” declared Dr. Aronne when presenting the latest analyses at the 2023 European Congress on Obesity. Full study results were published in the New England Journal of Medicine.
Moderator Gabriella Lieberman, MD, endocrinologist and head of the Israeli Center for Weight Management, Sheba Medical Center, Ramat-Gan, Israel, welcomed the study but also expressed caution. “It’s very potent, but as we see generally with potent therapies, I think it will change how we look at nutritional advice and the role of the dietician will change. I’m a bit worried the drug is running fast and the support, which is crucial with these treatments, is not keeping up, and we’ll have to deal with some effects later, such as sarcopenia,” she pointed out in an interview.
“We have to treat these drugs as if they are bariatric surgery. I see patients on these types of drugs in clinic and their appetite is so suppressed that they think they can afford to eat things that are unhealthy because they lose weight, and that’s what they want. There has to be a responsible adult looking at what they’re eating, and not just clapping their hands for the weight loss, but ensuring they are not deprived of anything,” she said.
Weight loss and body composition explored
Tirzepatide is a novel glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that works to activate the GIP and GLP-1 receptors, respectively, found in areas of the brain important for appetite regulation, decreasing food intake, and modulating fat utilization.
The phase 3, double-blind, randomized, controlled trial included data from 2,539 adults with a BMI greater than or equal to 30 kg/m2 (class I, II, III obesity) or greater than or equal to 27 kg/m2 (overweight) with one or more weight-related complications, excluding diabetes. At baseline, mean body weight was 104.8 kg, mean BMI was 38.0 kg/m2, and 94.5% of participants had BMI greater than or equal to 30 kg/m2.
Patients were randomized to once-weekly subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks. The primary objective was to show that tirzepatide was superior to placebo in terms of percentage change in body weight and proportion of participants with body-weight reduction of greater than or equal to 5%. The percentage change from baseline body weight and proportion of participants with body weight reduction greater than or equal to 5% were also assessed across BMI categories of greater than or equal to 27 to less than 30 kg/m2, greater than or equal to 30 to less than 35 kg/m2 (class 1 obesity), greater than or equal to 35 to less than 40 kg/m2 (class 2 obesity), and greater than or equal to 40 kg/m2 (class 3 obesity).
In addition, in a retrospective subanalysis, body composition was evaluated in a subpopulation that underwent dual-energy x-ray absorptiometry, assessing change from baseline body composition within age subgroups less than 50 years (n = 99), 50-64.9 years (n = 41), and greater than or equal to 65 years (n = 20).
The average weight reduction over the 72 weeks of follow-up was –16.0%, –21.4%, and –22.5% with tirzepatide 5 mg, 10 mg, and 15 mg, compared with –2.4% for participants taking placebo (all P < .001 vs. placebo).
The percentages of participants reaching target weight reductions of greater than or equal to 5%, greater than or equal to 10%, greater than or equal to 15%, greater than or equal to 20%, and greater than or equal to 25% were recorded. Over 90% achieved greater than or equal to 5% weight loss, irrespective of BMI and tirzepatide dose, while 55.5% and 62.9% in the 10-mg and 15-mg groups achieved greater than or equal to 20% weight loss, and 35.0% and 39.7% in the 10-mg and 15-mg groups achieved greater than or equal to 25% weight loss, respectively.
By increasing BMI category, in the 10-mg group, weight loss was –18.2 kg, –21.9 kg, –22.0, and –20.7 kg; and in the 15-mg group, weight loss was –18.1kg, –21.2 kg, –24.5 kg, and –22.8 kg. Weight loss in the 5-mg group ranged from –16.6 kg to –15.9 kg from lowest to highest BMI category.
“In the lower-weight categories, there is less weight to lose, so we see a flattening of the curve [with a] maximum of around 18%, so it may be that as we learn more about a drug that is so potent, we recognize that we don’t need to use such a high dose in people with BMI 27-30 kg/m2,” he explained. “It’s the higher BMI categories where we need the higher dose.”
As with lifestyle and surgical treatments, participants taking tirzepatide had around a three times greater percentage reduction in fat mass than lean mass, resulting in an overall improvement in body composition, reported Dr. Aronne.
“We want loss of fat, not lean mass, and we know that we lose around one part lean to three parts fat mass when on a diet and exercise regimen,” he went on to explain. “We see exactly this [balance of lean-to-fat-mass loss] here with 33.9% total fat mass reduction in the treatment group, compared with 8.2% in the placebo group.”
Visceral fat mass reduction was 40% in the treatment group, compared with 7.3% with placebo. “It’s good to see there’s more loss of visceral fat,” said Dr. Aronne. Lean mass loss was 10.9%. “So around three times greater reduction in fat over lean mass loss, resulting in overall improvement of body composition,” he reported.
Also, in older people (≥ 65 years) there was approximately no difference in fat versus lean mass loss, compared with younger people, despite older people being more likely to lose more lean mass.
With respect to patient-reported outcomes based on the 36-item Short-Form Health Survey (SF-36), Dr. Aronne said that physical functioning scores significantly improved at 72 weeks, compared with placebo, particularly in participants with physical function limitations at baseline.
“In an interesting subanalysis, those with physical limitations at baseline showed a significant improvement versus placebo of over 5% difference [considered significant],” he added.
Safety and tolerability were previously reported in the NEJM article. The most common adverse events with tirzepatide were gastrointestinal, and adverse events causing treatment discontinuation occurred in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg doses or placebo, respectively.
“A revolution is coming in the treatment of obesity and cardiometabolic disease, and most physicians cannot grasp this. We’re finally getting the efficacy we’ve been looking for that will produce benefits in every realm,” concluded Dr. Aronne. “These data show that we are now hitting all the secondary endpoints and making our patients better.”
“I think this bodes well. I always envisioned a time when the treatment of obesity would come first before the treatment of cardiometabolic complications of obesity, and I think we’re on the verge of that era with semaglutide, tirzepatide, and the very exciting treatments to come.”
The SURMOUNT-1 trial was sponsored by Lilly. Dr. Aronne is cofounder, chief scientific advisor, and a member of the board of directors for Intellihealth. He is also a paid scientific advisory board member for Eli Lilly.
A version of this article first appeared on Medscape.com.
Ear acupuncture with diet aids weight loss
DUBLIN – with high levels of visceral fat and overweight/obesity.
Three months of auricular acupuncture stimulation and dietary restriction led to a mean weight loss of nearly 9 kg plus a drop in waist circumference of more than 10 cm.
According to the researchers, acupuncture beads, used in Japan to augment weight loss for more than 30 years, are thought to stimulate nerves and organs that regulate appetite, satiety, hunger, and food cravings.
Findings of the observational study were presented by Takahiro Fujimoto, MD, PhD, Clinic F, Tokyo, at this year’s European Congress on Obesity.
Together with a prior study using the same intervention in women, Dr. Fujimoto and colleagues have now gathered data in more than 1,000 individuals, he said. “We wanted a method that was simple and noninvasive that would serve as a support to exercise and dietary therapy,” Dr. Fujimoto said in an interview.
“We believe there is an effect,” he asserted. “Acupuncture’s effect lies in stimulating the satiety center with benefits in helping individuals to control their food cravings and intake when reducing meals,” he said, pointing out that similar techniques have been used in patients undergoing withdrawal from drug addiction and in smoking cessation. He explained that acupuncture beads are believed to help individuals change their lifestyle habits, and added that “the relapse rate after 6 months is addressed in another paper, and it is very low.”
Professor Jason C.G. Halford, PhD, head of school at the University of Leeds, England, and president of the European Association for the Study of Obesity, commented on the findings. “There is no control group here receiving everything but the acupuncture,” he noted. “As such, it could be other elements of the intervention driving this [effect] including the act of keeping a food diary increasing awareness of one’s diet. A randomized controlled trial would be the next step.”
In women, the technique led to significantly more weight loss than in those who were untreated, and weight loss was maintained for 6 months after the end of treatment.
The researchers added that acupuncture stimulation with beads was a simpler method than traditional use of intradermal needles requiring expert acupuncturists. The stimulation is applied with 1.5-mm metal ear beads on 6 points of the outer ear (shen men, food pipe, upper stomach opening, stomach, lungs, and endocrine system) that correspond to meridian lines, and as such, restores the flow of qi by resolving any blockages or disruption. This may help with a variety of health conditions, according to the researchers. Placed on both ears, surgical tape was used to keep the beads in place to ensure participants continuously received uniform pressure on each of the six acupuncture points.
Dietary guidance was provided to participants to help reduce food intake by half, and nutritional supplements were given to compensate for any deficiencies. Participants attended twice-weekly clinic visits for bead sticking and diet progress monitoring. Body weight, body fat percentage, fat mass, lean mass, muscle mass, body mass index (BMI), and abdominal fat were assessed at the start and end of the study period.
“Since these tiny metal beads are attached to six points on the outer ear that stimulate nerves and organs which regulate appetite, satiety, and hunger, this type of acupuncture does not require complex knowledge or skill,” explained Dr. Fujimoto.
The results of the latest study, in men only, build on a prior study of more than 1,300 women who also received auricular acupuncture stimulation with beads as well as a halving of their food intake. In women, the weight loss program led to total body weight loss of 11.2% over 3 months.
At baseline, the 81 male participants, ages 21-78 years, had a mean BMI of 28.4 kg/m2 and mean waist circumference of 98.4 cm. Body fat percentage was 28.2%.
After 3 months, participants lost a mean of 8.6 kg (P < .001), decreased waist circumference by a mean of 10.4 cm (P < .001), and lost a mean of 4.0% of total body fat (P < .001). Visceral fat levels also fell by 2.2 points (P < .001), from 15.2 points at baseline to 13.0 points after 3 months. (A healthy visceral fat rating is between 1 and 12 points.) BMI decreased by almost 3 kg/m2 (from 28.4 at baseline to 25.5 at 3 months; P < .001).
Improvement in muscle-to-fat ratio was greater in men than women, whereas women had a greater decrease in percentage body fat than men.
“Whilst receiving ear acupuncture, the investigators asked participants to cut their food intake by half. It’s not unreasonable to expect that this major dietary change was the main reason participants lost weight,” remarked Graham Wheeler, PhD, statistical ambassador at the Royal Statistical Society, United Kingdom.
He also commented on the lack of a control group: “This study does not show us the impact of ear acupuncture on weight loss.”
Dr. Fujimoto and Dr. Halford have reported no relevant financial relationships. Dr. Wheeler is a statistical ambassador for the Royal Statistical Society, is employed by GSK, and holds an honorary senior lecturer post at Imperial College London.
A version of this article first appeared on Medscape.com.
DUBLIN – with high levels of visceral fat and overweight/obesity.
Three months of auricular acupuncture stimulation and dietary restriction led to a mean weight loss of nearly 9 kg plus a drop in waist circumference of more than 10 cm.
According to the researchers, acupuncture beads, used in Japan to augment weight loss for more than 30 years, are thought to stimulate nerves and organs that regulate appetite, satiety, hunger, and food cravings.
Findings of the observational study were presented by Takahiro Fujimoto, MD, PhD, Clinic F, Tokyo, at this year’s European Congress on Obesity.
Together with a prior study using the same intervention in women, Dr. Fujimoto and colleagues have now gathered data in more than 1,000 individuals, he said. “We wanted a method that was simple and noninvasive that would serve as a support to exercise and dietary therapy,” Dr. Fujimoto said in an interview.
“We believe there is an effect,” he asserted. “Acupuncture’s effect lies in stimulating the satiety center with benefits in helping individuals to control their food cravings and intake when reducing meals,” he said, pointing out that similar techniques have been used in patients undergoing withdrawal from drug addiction and in smoking cessation. He explained that acupuncture beads are believed to help individuals change their lifestyle habits, and added that “the relapse rate after 6 months is addressed in another paper, and it is very low.”
Professor Jason C.G. Halford, PhD, head of school at the University of Leeds, England, and president of the European Association for the Study of Obesity, commented on the findings. “There is no control group here receiving everything but the acupuncture,” he noted. “As such, it could be other elements of the intervention driving this [effect] including the act of keeping a food diary increasing awareness of one’s diet. A randomized controlled trial would be the next step.”
In women, the technique led to significantly more weight loss than in those who were untreated, and weight loss was maintained for 6 months after the end of treatment.
The researchers added that acupuncture stimulation with beads was a simpler method than traditional use of intradermal needles requiring expert acupuncturists. The stimulation is applied with 1.5-mm metal ear beads on 6 points of the outer ear (shen men, food pipe, upper stomach opening, stomach, lungs, and endocrine system) that correspond to meridian lines, and as such, restores the flow of qi by resolving any blockages or disruption. This may help with a variety of health conditions, according to the researchers. Placed on both ears, surgical tape was used to keep the beads in place to ensure participants continuously received uniform pressure on each of the six acupuncture points.
Dietary guidance was provided to participants to help reduce food intake by half, and nutritional supplements were given to compensate for any deficiencies. Participants attended twice-weekly clinic visits for bead sticking and diet progress monitoring. Body weight, body fat percentage, fat mass, lean mass, muscle mass, body mass index (BMI), and abdominal fat were assessed at the start and end of the study period.
“Since these tiny metal beads are attached to six points on the outer ear that stimulate nerves and organs which regulate appetite, satiety, and hunger, this type of acupuncture does not require complex knowledge or skill,” explained Dr. Fujimoto.
The results of the latest study, in men only, build on a prior study of more than 1,300 women who also received auricular acupuncture stimulation with beads as well as a halving of their food intake. In women, the weight loss program led to total body weight loss of 11.2% over 3 months.
At baseline, the 81 male participants, ages 21-78 years, had a mean BMI of 28.4 kg/m2 and mean waist circumference of 98.4 cm. Body fat percentage was 28.2%.
After 3 months, participants lost a mean of 8.6 kg (P < .001), decreased waist circumference by a mean of 10.4 cm (P < .001), and lost a mean of 4.0% of total body fat (P < .001). Visceral fat levels also fell by 2.2 points (P < .001), from 15.2 points at baseline to 13.0 points after 3 months. (A healthy visceral fat rating is between 1 and 12 points.) BMI decreased by almost 3 kg/m2 (from 28.4 at baseline to 25.5 at 3 months; P < .001).
Improvement in muscle-to-fat ratio was greater in men than women, whereas women had a greater decrease in percentage body fat than men.
“Whilst receiving ear acupuncture, the investigators asked participants to cut their food intake by half. It’s not unreasonable to expect that this major dietary change was the main reason participants lost weight,” remarked Graham Wheeler, PhD, statistical ambassador at the Royal Statistical Society, United Kingdom.
He also commented on the lack of a control group: “This study does not show us the impact of ear acupuncture on weight loss.”
Dr. Fujimoto and Dr. Halford have reported no relevant financial relationships. Dr. Wheeler is a statistical ambassador for the Royal Statistical Society, is employed by GSK, and holds an honorary senior lecturer post at Imperial College London.
A version of this article first appeared on Medscape.com.
DUBLIN – with high levels of visceral fat and overweight/obesity.
Three months of auricular acupuncture stimulation and dietary restriction led to a mean weight loss of nearly 9 kg plus a drop in waist circumference of more than 10 cm.
According to the researchers, acupuncture beads, used in Japan to augment weight loss for more than 30 years, are thought to stimulate nerves and organs that regulate appetite, satiety, hunger, and food cravings.
Findings of the observational study were presented by Takahiro Fujimoto, MD, PhD, Clinic F, Tokyo, at this year’s European Congress on Obesity.
Together with a prior study using the same intervention in women, Dr. Fujimoto and colleagues have now gathered data in more than 1,000 individuals, he said. “We wanted a method that was simple and noninvasive that would serve as a support to exercise and dietary therapy,” Dr. Fujimoto said in an interview.
“We believe there is an effect,” he asserted. “Acupuncture’s effect lies in stimulating the satiety center with benefits in helping individuals to control their food cravings and intake when reducing meals,” he said, pointing out that similar techniques have been used in patients undergoing withdrawal from drug addiction and in smoking cessation. He explained that acupuncture beads are believed to help individuals change their lifestyle habits, and added that “the relapse rate after 6 months is addressed in another paper, and it is very low.”
Professor Jason C.G. Halford, PhD, head of school at the University of Leeds, England, and president of the European Association for the Study of Obesity, commented on the findings. “There is no control group here receiving everything but the acupuncture,” he noted. “As such, it could be other elements of the intervention driving this [effect] including the act of keeping a food diary increasing awareness of one’s diet. A randomized controlled trial would be the next step.”
In women, the technique led to significantly more weight loss than in those who were untreated, and weight loss was maintained for 6 months after the end of treatment.
The researchers added that acupuncture stimulation with beads was a simpler method than traditional use of intradermal needles requiring expert acupuncturists. The stimulation is applied with 1.5-mm metal ear beads on 6 points of the outer ear (shen men, food pipe, upper stomach opening, stomach, lungs, and endocrine system) that correspond to meridian lines, and as such, restores the flow of qi by resolving any blockages or disruption. This may help with a variety of health conditions, according to the researchers. Placed on both ears, surgical tape was used to keep the beads in place to ensure participants continuously received uniform pressure on each of the six acupuncture points.
Dietary guidance was provided to participants to help reduce food intake by half, and nutritional supplements were given to compensate for any deficiencies. Participants attended twice-weekly clinic visits for bead sticking and diet progress monitoring. Body weight, body fat percentage, fat mass, lean mass, muscle mass, body mass index (BMI), and abdominal fat were assessed at the start and end of the study period.
“Since these tiny metal beads are attached to six points on the outer ear that stimulate nerves and organs which regulate appetite, satiety, and hunger, this type of acupuncture does not require complex knowledge or skill,” explained Dr. Fujimoto.
The results of the latest study, in men only, build on a prior study of more than 1,300 women who also received auricular acupuncture stimulation with beads as well as a halving of their food intake. In women, the weight loss program led to total body weight loss of 11.2% over 3 months.
At baseline, the 81 male participants, ages 21-78 years, had a mean BMI of 28.4 kg/m2 and mean waist circumference of 98.4 cm. Body fat percentage was 28.2%.
After 3 months, participants lost a mean of 8.6 kg (P < .001), decreased waist circumference by a mean of 10.4 cm (P < .001), and lost a mean of 4.0% of total body fat (P < .001). Visceral fat levels also fell by 2.2 points (P < .001), from 15.2 points at baseline to 13.0 points after 3 months. (A healthy visceral fat rating is between 1 and 12 points.) BMI decreased by almost 3 kg/m2 (from 28.4 at baseline to 25.5 at 3 months; P < .001).
Improvement in muscle-to-fat ratio was greater in men than women, whereas women had a greater decrease in percentage body fat than men.
“Whilst receiving ear acupuncture, the investigators asked participants to cut their food intake by half. It’s not unreasonable to expect that this major dietary change was the main reason participants lost weight,” remarked Graham Wheeler, PhD, statistical ambassador at the Royal Statistical Society, United Kingdom.
He also commented on the lack of a control group: “This study does not show us the impact of ear acupuncture on weight loss.”
Dr. Fujimoto and Dr. Halford have reported no relevant financial relationships. Dr. Wheeler is a statistical ambassador for the Royal Statistical Society, is employed by GSK, and holds an honorary senior lecturer post at Imperial College London.
A version of this article first appeared on Medscape.com.
AT ECO 2023
Half of teens drop below obesity cutoff with semaglutide
DUBLIN – according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.
The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.
“In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery,” remarked Aaron S. Kelly, MD, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis, who presented the latest data at this year’s European Congress on Obesity.
“There was a 22.7-higher odds of dropping below the obesity threshold if assigned to semaglutide versus odds on placebo (P < .0001), and a 23.5-fold higher odds of dropping BMI by one category if on semaglutide (P < .0001),” he reported.
This analysis follows the 2022 publication of the main results of STEP TEENS published in the New England Journal of Medicine, which showed semaglutide helped adolescents lose weight. The drug was subsequently approved by the U.S. Food and Drug Administration for the treatment of obesity in those aged 12 and over in January of this year.
The new analysis was presented at ECO and simultaneously published in Obesity.
Grace O’Malley, PhD, Child & Adolescent Obesity Service, Children’s Health Ireland, Dublin, commented on the findings, noting that adolescents’ access to comprehensive health care is essential for the proper treatment of obesity.
“Treatment requires a long-term, multidisciplinary chronic-care approach, and usually, when treatment stops, the biological mechanisms driving the obesity begin again to drive the build-up of adipose tissue,” she said. This means that “long-term treatment including nutrition therapy, exercise ... behavioral support, and sleep therapy needs to be available to families in combination with pharmacotherapy and surgical intervention where required.”
“The results of the STEP TEENS study represent a promising development for the treatment of adolescent obesity and for associated complications related to liver function,” she added. “The observed improvements in obesity category and [liver enzyme] alanine transaminase will help clinicians plan more tailored care for adolescents with obesity,” she noted.
Semaglutide shifts BMI category
In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.
The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).
After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.
Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.
At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.
“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.
Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”
Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.
For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.
In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.
“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”
Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”
Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”
Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.
A version of this article first appeared on Medscape.com.
DUBLIN – according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.
The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.
“In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery,” remarked Aaron S. Kelly, MD, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis, who presented the latest data at this year’s European Congress on Obesity.
“There was a 22.7-higher odds of dropping below the obesity threshold if assigned to semaglutide versus odds on placebo (P < .0001), and a 23.5-fold higher odds of dropping BMI by one category if on semaglutide (P < .0001),” he reported.
This analysis follows the 2022 publication of the main results of STEP TEENS published in the New England Journal of Medicine, which showed semaglutide helped adolescents lose weight. The drug was subsequently approved by the U.S. Food and Drug Administration for the treatment of obesity in those aged 12 and over in January of this year.
The new analysis was presented at ECO and simultaneously published in Obesity.
Grace O’Malley, PhD, Child & Adolescent Obesity Service, Children’s Health Ireland, Dublin, commented on the findings, noting that adolescents’ access to comprehensive health care is essential for the proper treatment of obesity.
“Treatment requires a long-term, multidisciplinary chronic-care approach, and usually, when treatment stops, the biological mechanisms driving the obesity begin again to drive the build-up of adipose tissue,” she said. This means that “long-term treatment including nutrition therapy, exercise ... behavioral support, and sleep therapy needs to be available to families in combination with pharmacotherapy and surgical intervention where required.”
“The results of the STEP TEENS study represent a promising development for the treatment of adolescent obesity and for associated complications related to liver function,” she added. “The observed improvements in obesity category and [liver enzyme] alanine transaminase will help clinicians plan more tailored care for adolescents with obesity,” she noted.
Semaglutide shifts BMI category
In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.
The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).
After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.
Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.
At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.
“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.
Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”
Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.
For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.
In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.
“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”
Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”
Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”
Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.
A version of this article first appeared on Medscape.com.
DUBLIN – according to a secondary analysis of the STEP TEENS (Semaglutide Treatment Effect in People With Obesity) trial.
By comparison, only 12.1% of adolescents with obesity taking placebo in the trial dropped below the obesity threshold.
The study also found that 74% of participants shifted down by at least one body mass index (BMI) category after receiving the GLP-1 agonist, compared with 19% of those taking placebo.
“In a practical sense, we see that semaglutide reduced weight to a level below what is defined as clinical obesity in nearly 50% of the teens in our trial, which is historically unprecedented with treatments other than bariatric surgery,” remarked Aaron S. Kelly, MD, codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota, Minneapolis, who presented the latest data at this year’s European Congress on Obesity.
“There was a 22.7-higher odds of dropping below the obesity threshold if assigned to semaglutide versus odds on placebo (P < .0001), and a 23.5-fold higher odds of dropping BMI by one category if on semaglutide (P < .0001),” he reported.
This analysis follows the 2022 publication of the main results of STEP TEENS published in the New England Journal of Medicine, which showed semaglutide helped adolescents lose weight. The drug was subsequently approved by the U.S. Food and Drug Administration for the treatment of obesity in those aged 12 and over in January of this year.
The new analysis was presented at ECO and simultaneously published in Obesity.
Grace O’Malley, PhD, Child & Adolescent Obesity Service, Children’s Health Ireland, Dublin, commented on the findings, noting that adolescents’ access to comprehensive health care is essential for the proper treatment of obesity.
“Treatment requires a long-term, multidisciplinary chronic-care approach, and usually, when treatment stops, the biological mechanisms driving the obesity begin again to drive the build-up of adipose tissue,” she said. This means that “long-term treatment including nutrition therapy, exercise ... behavioral support, and sleep therapy needs to be available to families in combination with pharmacotherapy and surgical intervention where required.”
“The results of the STEP TEENS study represent a promising development for the treatment of adolescent obesity and for associated complications related to liver function,” she added. “The observed improvements in obesity category and [liver enzyme] alanine transaminase will help clinicians plan more tailored care for adolescents with obesity,” she noted.
Semaglutide shifts BMI category
In this new secondary analysis of STEP TEENS, the authors examined the effect of subcutaneous semaglutide 2.4 mg on moving adolescents from one BMI category to another, including dropping below the obesity threshold into the overweight or normal weight categories.
The study also looked at the effect of semaglutide on glucose metabolism and cardiovascular risk factors, as well as safety and tolerability. However, this particular analysis only examined adolescents with obesity (only one person had overweight, and so they were excluded), who were divided into three further subclasses: obesity class I (BMI ≥ 95th to < 20% above the 95th percentile); obesity class II (BMI ≥ 20% to < 40% above 95th percentile); and obesity class III (BMI ≥ 40% above the 95th percentile).
After a 12-week run-in period of lifestyle intervention only, a total of 200 adolescents (12-18 years) with obesity (in the top 5% of BMI) were randomized (2:1) to once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, after a 16-week titration period. All participants continued to receive counseling about healthy nutrition and were set a goal of 60 minutes per day of moderate- to high-intensity physical activity.
Dr. Kelly and colleagues determined levels of improvement in BMI category and attainment of normal weight, or overweight, BMI category by week 68.
At baseline, the percentage of participants in obesity class I, II, or III, in those taking placebo was 39.7%, 41.4%, and 19.0%, or taking semaglutide was 31.4%, 31.4%, and 37.3%, respectively.
“After 68 weeks, not a lot happened [in placebo participants]; however, 12.1% of placebo participants did drop below the obesity threshold into overweight or normal-weight categories,” reported Dr. Kelly.
Referring to participants taking semaglutide, he added that “a total of 45% of patients on semaglutide dropped below the clinical BMI cut point for obesity, such that 19.5% dropped into the overweight category and 25.4% reduced their BMI into the normal-weight category.”
Turning to obesity class, Dr. Kelly reported that of those initially with obesity class III taking placebo, 91% remained in that class and 9.1% dropped to obesity class II at week 68. For those adolescents with obesity class III taking semaglutide, 36.4% dropped to obesity class II, 18.2% dropped to obesity class I, 11% dropped below the obesity threshold, and 34.1% remained in obesity class III, he added.
For obesity class II specifically, 71% of placebo participants stayed in that category, while 12% moved up a category. “On semaglutide, over 50% (51.2%) reduced their BMI below the obesity cut point,” noted Dr. Kelly.
In obesity class I, 26% of patients taking placebo reduced their BMI below the obesity cut point. “On semaglutide, nearly 80% reduced their BMI below the obesity threshold, with 57% dropping their BMI into the normal category,” he said.
“When we looked at baseline factors that might predict the response to semaglutide or placebo, we did not find any factors that were ... significant due to small sample sizes,” he said. However, he pointed out that “females tended to respond better to semaglutide, likewise younger adolescents, and middle body weights tended to respond better to the drug, and there was a similar pattern with obesity classes.”
Commenting on the study, Jesse Bittman, MD, University of British Columbia, Vancouver, said: “Good to see more data on different populations that some semaglutide is used in and the variability in response to it. The focus on BMI was interesting because in obesity medicine we spend a lot of time telling our patients not to focus on BMIs and ‘normals’ because there are more important tools, and we see that when these become the focus of research outcomes they can become problematic.”
Asked whether rapid weight loss in adolescents might be problematic in some respects, Dr. Bittman pointed out that “one concern with these medications is whether people are going to have loss of muscle mass or malnutrition, or whether they develop eating disorders and other disturbed eating behaviors.”
Dr. Kelly has reported engaging in unpaid consulting and educational activities for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Vivus, and receiving donated drug/placebo from Novo Nordisk and Vivus for National Institutes of Health–funded clinical trials. Dr. O’Malley has declared having received grants in the past 3 years from the Health Research Board, Department of Health, Ireland, European Association for the Study of Obesity (via a Novo Nordisk educational grant), Healthy Ireland fund, and the Royal College of Surgeons in Ireland Strategic Academic Recruitment (StAR) Programme. Dr. Bittman has reported receiving funding from Novo Nordisk, Bayer, and Bausch Health.
A version of this article first appeared on Medscape.com.
FROM ECO 2023
Obesity drug with swallowable balloon boosts weight loss
DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.
said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.
“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.
“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.
The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m2.
The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.
The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”
Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”
“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
Average 40-lb weight loss with balloon and liraglutide
For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.
During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.
Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”
Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.
Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m2. After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m2 respectively.
After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m2.
Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.
When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”
Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).
Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.
The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.
“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”
A version of this article originally appeared on Medscape.com.
DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.
said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.
“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.
“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.
The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m2.
The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.
The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”
Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”
“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
Average 40-lb weight loss with balloon and liraglutide
For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.
During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.
Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”
Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.
Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m2. After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m2 respectively.
After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m2.
Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.
When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”
Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).
Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.
The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.
“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”
A version of this article originally appeared on Medscape.com.
DUBLIN – A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagonlike peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.
said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, who presented the findings at this year’s European Congress on Obesity.
“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she said in an interview.
“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.
The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m2.
The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.
The Allurion program delivered “excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in cases of suboptimal adherence with the program,” Dr. Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”
Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, said that he had over 6 years of experience with the Allurion balloon in around 2,500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”
“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide] with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
Average 40-lb weight loss with balloon and liraglutide
For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon and liraglutide, with the latter added 4-16 weeks after swallowing the balloon.
During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by x-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1-6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.
Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Dr. Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”
Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a time point or percentage weight loss.
Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m2. After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m2 respectively.
After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m2.
Dr. Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.
When describing the mechanism of action, Dr. Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”
Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).
Balloon removal because of intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.
The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.
“The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention, and ultimately, help the millions who struggle with obesity and its associated health complications.”
A version of this article originally appeared on Medscape.com.
AT ECO 2023