Outcomes from the BARI-OPTIMISE randomised clinical trial, which assessed 24 weeks of liraglutide (3.0mg) as an adjunct to a lifestyle intervention in people with poor weight loss and a suboptimal GLP-1 response after metabolic surgery, has concluded the medication was safe, well tolerated and led to clinically meaningful reductions in body weight. The results were featured in the paper, ‘Safety and Efficacy of Liraglutide, 3.0 mg, Once Daily vs Placebo in Patients With Poor Weight Loss Following Metabolic Surgery - The BARI-OPTIMISE Randomized Clinical Trial’, published in JAMA Surgery.
“To our knowledge, the BARI-OPTIMISE trial is the first randomized clinical trial to evaluate the efficacy and safety of liraglutide, 3.0 mg, compared to placebo as an adjunct to a lifestyle intervention in people with suboptimal weight loss after metabolic surgery,” the paper’s authors write.
BARI-OPTIMISE is a double-blinded, randomised, placebo-controlled, parallel group trial, that recruited patients with poor weight loss and a suboptimal nutrient-stimulated GLP-1 response at least 12 months following primary RYGB or SG. The trial, undertaken at University College London Hospital (UCLH), recruited patients from UCLH and Homerton University Hospital, London, UK.
The investigators defined ‘poor weight loss’ as 20% or less total body weight loss from the day of surgery and suboptimal GLP-1 response was defined as a two-fold or less increase in circulating active GLP-1 between 0 and 30 minutes following a meal (circulating GLP-1 levels were measured in the fasted state and 30 minutes following a 500-kcal test meal).
In total, 70 participants (52 [74%] female) were randomly assigned (1:1) to either liraglutide 3.0mg (Novo Nordisk) or placebo (saline solution), via self-administered once daily subcutaneous injections with identical-appearing pens. The primary end point was percentage change in body weight from baseline to week 24.
At follow-up, there were 31 participants in the liraglutide 3.0mg group and 26 in the placebo group (the pandemic lockdown measures impacted upon conduct of final visit blood tests, dual energy X-ray absorptiometry, and physical functional testing).
From baseline to week 24, participants in the 3.0-mg liraglutide group had a greater reduction in percentage body weight, compared with the placebo group (p<0.001). The mean difference in percentage body weight change was −8.03. In the per-protocol analysis, the liraglutide 3.0mg group showed greater percentage change in body weight vs. the placebo group - consistent with the results for the primary analysis. In addition, a greater proportion of participants in the liraglutide group lost 5% or more of their body weight (71.9% vs 8.8%).
Adverse events, predominantly gastrointestinal, were more common in the liraglutide group (28 events [80%]) vs placebo 20 events [57%]). There were no serious adverse events in either group, no reports of acute cholecystitis or pancreatitis, and no treatment-related deaths.
“Our findings show that liraglutide, 3.0 mg, for 24 weeks led to a significantly greater reduction in percentage body weight compared to placebo, coupled with reduced fat mass, favourable changes in cardiometabolic risk factors, and improvement in health-related quality of life,” the author’s concluded. “…Our findings therefore suggest that liraglutide, 3.0 mg, may have a role in the treatment of people with poor weight loss following metabolic surgery.”
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