Oral Abstracts
2021; Wiley; Volume: 29; Issue: S2 Linguagem: Inglês
10.1002/oby.23328
ISSN1930-739X
AutoresJaclyn S Lo, Dabom New, York Ny, Robert Hold, Pa-C New, George Fielding, New Ny, Bradley Schwack, Leah Kaufman, Cdn New, Zipporah Oksman, Gabrielle Maranga, Sean Heffron, Christine Fielding, Emily W. Flanagan, Abby D. Altazan, Kristen E. Boyle, Aurora Co, Leanne M. Redman, Ftos Baton, Naser Jafari, Boston Ma, Manohar Kolla, Tova Meshulam, Jordan Shafran, Yuhan Qiu, Allison N. Casey, Carla Mazzeo, Nabil Rabhi, Stephen G. Farmer, Gerald V. Denis, Ningxiang Zeng, Elam Cutts, Christian Blanco, Simran Kaur, SONJA VIRKUS, Andrew Hardaway, Birmingham Al, Lizeth Cifuentes, Rochester Mn, Alison Mcrae, Sneha Singh, Gerardo Calderón, Alejandro Campos, María Laura, Ricardo Silgado, Jessica Stutzman, Megan Shaefer, Duane D. Burton, Andres Acosta, Sophia V. Hua, Aviva A. Musicus, Scd Boston, Anne N. Thorndike, Erica L. Kenney, Eric B. Rimm,
Tópico(s)Pharmaceutical studies and practices
ResumoBackground: Obesity is a global epidemic.Bariatric surgeries, Roux-en-Y gastric bypass (RYGB) with lifestyle modification, remains the gold standard for treating obesity.Still, weight regain (WR) is common after RYGB.Conservative modalities can be unsuccessful in reversing WR and revisional surgeries can increase patients' risk.Liraglutide (LA) is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved for weight management at 3.0 mg/day via subcutaneous injection.This study examines the effects of LA 3.0 mg/day on WR after RYGB.Methods: A 56 week, double-blind, placebo-controlled study was conducted in 132 patients who achieved ≥25% total body weight loss (TBWL) after RYGB and had WR ≥ 10% TBWL after reaching post-operative nadir weight.Patients were 18-120 months post-RYGB and met criteria for weight management pharmacotherapy.Using a 2:1 block randomization method, patients were stratified by gender and percent post-operative TBWL (≤25% or 25-49.9%) to receive LA 3.0 mg/day (n = 89) or placebo (n = 43).Both arms attended clinic visits every 3 months from baseline to 56 weeks and received lifestyle counseling from registered dieticians.The primary endpoint was the proportion of patients losing >5% of baseline body weight (BWL-B).Results: At baseline, patients were 47.2 years (SD = 10.1),99.3 kg (SD = 18.8), had a BMI 35.6 kg/m2 (SD = 4.7), and had RYGB 73.1 months (SD = 47.8)prior.At week 56, the median weight lost from BWL-B was 9.7% (IQR = 2.4-15.0)and -1.8% (IQR = -4.2-0.7) in the LA and placebo arms, respectively (p < 0.00001).After 56 weeks, 69% of LA arm lost ≥5% BWL-B versus 4.8% of placebo arm (p < 0.0001).48.3% of LA arm lost ≥10% BWL-B (p < 0.0001) and 24.1% lost ≥15% BWL-B (p < 0.013); none on placebo met these goals.20.7% of LA arm met or exceeded their post-op nadir weight; none on placebo met this goal (p = 0.024).41.6% of LA arm had GI related side effects; serious adverse events (SAE) were fewer in LA (n = 4) than in placebo (n = 6) (p = 0.009).No deaths occurred in either group. Conclusions:In this study, liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events.
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