Boosting weight loss after conversional RYGB with liraglutide and placebo use. A double-blind- randomized controlled trial

Abstract

Background: Conversional bariatric surgery inherently has less weight loss (WL) compared to primary procedures. Adjunctive use of the GLP-1analogue, liraglutide with conversional Roux-en-RYGB Gastric Bypass (cRYGB) may maximize the WL benefits of surgery. Material and methods: This single-center randomized double-blind placebo-controlled trial included 80 patients randomized into two groups; the liraglutide group (40 patients) who received daily injections of liraglutide, and the placebo group (40 patients) who received normal saline starting at 6-weeks from cRYGB and continued for 6 months. After discontinuing the drugs at 6 months and unblinding, the patient were followed up to 12 months. The endpoints were percentage of total weight loss (%TWL) and percentage of excess weight loss (%EWL), and changes in the metabolic biomarkers, and complications within 30 and 90 days according to the global outcome benchmark (GOB) stratification. Results: In total, 38 patients in the liraglutide group and 31 in the placebo group completed the 24 weeks. Liraglutide group experienced better WL with a significantly higher mean %TWL at one month (10.27±1.39 vs. 8.41±2.08), at 6 weeks (12.65±1.77 vs. 10.47±2.23), at 6 months (18.29 ±1.74vs. 15.58 ±1.65), and at 12 months 24.15±2.35 versus 22.70±2.13 (all P<0.001). For %EWL, this was also significantly higher in the liraglutide group at all time points. A %TWL of>20% at 6 months of treatment was recorded in 6 (15.8%) patients in the liraglutide group and none in the placebo group (P=0.029). Both groups had comparable changes in metabolic biomarkers. Adverse events were recorded in 11 (27.5%) patients in the liraglutide, with no adverse events in the placebo group (P<0.001). Both groups had Clavien-Dindo scores I and II (5.0% and 2.5%), and GOB values indicated that 90.0% and 97.5% were low-risk patients. Conclusion: Adjunctive use of liraglutide with cRYGB gives significantly higher WL and resolution of associated medical problems.