ObesityWeek 2021. Liraglutide helped patients who regained weight after successful gastric bypass surgery re-achieve their lowest weight with an acceptable safety profile.
Liraglutide 3 mg/day combined with lifestyle modification was significantly more effective than placebo in treating weight regain after Rouen-Y gastric bypass surgery (RYGB), found authors of a new study presented during ObesityWeek 2021.
Researchers, led by Holly F. Lofton, MD, DABOM, Clinical Associate Professor of Surgery and Medicine, NYU Grossman School of Medicine, report that after 56 weeks, more than two-thirds (69%) of patients receiving liraglutide had lost ≥5% of their total body weight (TBW) compared with less than 5% of those in the placebo group who lost the same amount. Nearly one-quarter of the liraglutide-treated patients had lost ≥15% of their TBW.
As context for their research, Lofton et al explain that while bariatric surgery, RYGB with lifestyle intervention, represent a gold standard for treatment of obesity, weight regain is common after the procedure. Reversing weight regain using conservative methods has a low success rate and revision surgeries put patients at increased risk, they write.
Liraglutide is approved for weight management and the current study was designed to evaluate the effects of the glucagon-like peptide-1 receptor agonist (GLP-1 RA) on weight regain in patients post-RYGB surgery.
Lofton and colleagues recruited 132 patients who were 18-120 months post-RYGB, had lost ≥25% of their TBW after the surgery, and had regained ≥10% of that TBW after reaching their lowest post-operative weight.
For the double-blind, placebo-controlled study, investigators used a 2:1 block randomization method, stratifying patients by gender and percentage of original post-operative total weight loss (≤25% or 25–49.9%) to receive liraglutide 3.0 mg/day (n=89) or placebo (n=43).
All participants made clinic visits every 3 months from study baseline to 56 weeks and received lifestyle counseling from registered dieticians.
As a primary endpoint, the authors were interested in the proportion of patients losing >5% of their baseline body weight.
At baseline, patients were aged 47.2 years (SD=10.1), weighed 99.3 kg (SD=18.8), had a BMI 35.6 kg/m2 (SD=4.7), and had undergone RYGB 73.1 months (SD=47.8) earlier.
At follow-up week 56, the authors report, the median weight loss from baseline for those in the liraglutide group was 9.7% (interquartile range [IQR]=2.4–15.0) and -1.8% for participants receiving placebo (IQR=-4.2–0.7) (p<.001).
After 56 weeks, 69% of patients receiving liraglutide had lost ≥5% of their baseline TBW vs 4.8% of those in the placebo arm ((p<.001). Further, according to the study abstract, 48.3% of liraglutide-treated participants has lost ≥10% of their baseline TBW (p<.001) and 24.1% had lost ≥15% of TBW (p<0.013). No participants in the placebo group reached those targets.
In the liraglutide group, the authors report, 20.7% of participants met or exceeded their lowest post-operative weight; none in the placebo group met this target (p=0.024).
Four in ten participants in the liraglutide treatment group experienced gastrointestinal-related side effects, a known class effect, and there were 4 serious adverse events in the liraglutide group vs 6 in the placebo group (p=0.009). No deaths were reported.
The authors conclude that weight regain after RYGB may be treated significantly more effectively with liraglutide 3.0 mg/day vs placebo with an acceptable safety profile.
Reference: Lofton HF, Hold RP, Fielding G, et al. A randomized, double-blind, placebo-controlled trial using liraglutide for weight regain after RYGB. Oral abstract 101, presented at ObesityWeek 2021, held online November 1-5, 2021.