The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was shown to be safe and effective for the treatment of weight gain after Roux-en-Y gastric bypass (RYGB) in a randomized controlled trial.
That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% again were randomized in a 2: 1 ratio and received liraglutide plus frequent lifestyle advice from a registered dietitian or just lifestyle advice.
After one year, 69%, 48%, and 24% of patients who received liraglutide lost at least 5%, 10%, and 15% of their entry weight, respectively. In contrast, only 5% of the patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.
“Liraglutide 3.0 mg / day with lifestyle change was significantly more effective than placebo at treating RYGB weight gain without increasing the risk of serious side effects,” summarized Holly F. Lofton, MD, in an oral session on the week virtual ObesityWeek together ® meeting 2021.
Lofton, a clinical associate professor of surgery and medicine and director of the weight management program at NYU, Langone Health, New York City, told Medscape Medical News that she initiated the study after following a “full” session on weight gain had attended bariatric surgery at a previous conference of the American Society of Metabolic and Bariatric Surgery.
“The lecturers recommended conservative measures (such as repeating dietary recommendations, exercise, [and] Counseling) and revision surgery, “she said in an email, but at the time,” there was “no literature providing guidance on which pharmacotherapies are best for this population group”.
A decrease in endogenous GLP-1 levels was known to coincide with an increase in weight, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight control at the time. Therefore, she developed the current study protocol.
The results are especially helpful for patients who are not candidates for bariatric surgery revision, she noted. More research is needed to examine the effect of newer GLP-1 agonists such as semaglutide (Wegovy) on weight gain after various bariatric surgery.
When asked for comment, Wendy C. King, PhD, who was not involved in this study, said that more than two-thirds of the patients treated with subcutaneous injections of 3 mg of liraglutide per day in the current study had at least 5% of their own Starting weight lost a year later, and 20% of them gained weight as low or lower as their lowest weight after bariatric surgery (nadir weight).
“The fact that both groups received lifestyle advice from registered nutritionists for a little over a year, but only patients in the liraglutide group lost an average of weight, suggests the difficulty of losing weight after gaining weight after bariatric surgery “added King. Associate Professor of Epidemiology at the University of Pittsburgh in Pennsylvania.
This study “provides data that can help doctors and patients understand the potential effect of adding liraglutide 3.0 mg / day to their weight loss efforts,” she told Medscape Medical News in an email.
“Given that 42% of patients receiving liraglutide reported gastrointestinal side effects, patients should also be given advice on this potential outcome and suggestions to minimize such side effects,” suggested King.
Frequent weight gain, repeated surgery carries risks
Weight gain is common years after bariatric surgery. Repeated surgery carries some risk, and lifestyle approaches alone are rarely successful in reversing the weight gain, Lofton told the audience.
The researchers enrolled 132 adults who had an average weight of 134 kg (295 pounds) when they underwent RYGB and who had lost at least 25% of their original weight (average weight loss of 38%), but also increased again, after surgery at least 10% of their starting weight.
At baseline, patients had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg / m2. None of the patients had diabetes.
Patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.
Their average age was 48 and around 59% were white and 25% were black.
All patients had clinic visits every 3 months where they received lifestyle advice from a registered dietitian.
After 12 months, the patients in the liraglutide group had lost an average of 8.8% of their starting weight, while the patients in the placebo group had gained an average of 1.48% of their starting weight.
There were no significant intergroup differences in cardiometabolic variables.
None of the patients in the control group achieved a weight according to RYGB that was as low as their nadir weight.
The rates of nausea (25%), constipation (16%) and abdominal pain (10%) were higher in the liraglutide group than in the placebo group (7%, 14% and 5%, respectively) but similar to the rates of gastrointestinal side effects in other studies with this active ingredient.
Lofton announced that it has received consulting fees and speaker office fees for Novo Nordisk, and has received research grants from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. King has not reported any relevant financial relationships.
ObesityWeek® 2021. Presented November 2, 2021.
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