The relationship between early weight loss and weight loss maintenance with naltrexone-bupropion therapy. (July 2022)

• Record Type: Journal Article
• Authors: le Roux, Carel W.; Fils-Aimé, Nadège; Camacho, Fernando; Gould, Errol; Barakat, Maxime
• Is Part Of: EClinicalMedicine. Volume 49(2022)
• Publication Date: 2022-07
• Subjects: Naltrexone/bupropion -- Maintenance -- Weight loss -- COR-BMOD -- COR-DM -- COR-I -- COR-II -- LIGHT -- IGNITE; AHEAD Action in Health for Diabetes -- BMI body mass index -- BMOD behavior modification therapy -- CBT cognitive behavioral therapy -- CI confidence interval -- CLI comprehensive lifestyle intervention -- COR Contrave Obesity Research -- DM diabetes mellitus -- ER extended-release -- MACE major adverse cardiovascular events -- NAFLD non-alcoholic fatty liver disease -- NB naltrexone/bupropion -- NWCR National Weight Control Registry -- SAEs serious adverse events -- SD standard deviation -- SMD standardized mean difference; Medicine -- Research -- Periodicals; Medical policy -- Periodicals; Clinical Medicine; Health Policy; Public Health; Medical policy; Medicine -- Research; Periodical; Electronic journals; Periodicals; 613
• DOI: 10.1016/j.eclinm.2022.101436
• Languages: English
• ISSNs: 2589-5370

Abstract

Summary: Background: Extended-release (ER) naltrexone/bupropion (NB) was associated with greater weight loss than placebo in four randomized, 56-week trials. The association of NB with longer-term maintenance of weight loss remains unknown. Methods: We conducted a post-hoc analysis of four phase III, randomized, double-blind, placebo-controlled, 56-week studies (COR-I, COR-II, COR-BMOD, and COR-DM), the placebo-controlled cardiovascular outcomes trial LIGHT (208 weeks), and the randomized, open-label trial IGNITE (78 weeks). Included subjects were treated with NB 32 mg/360 mg or placebo, with baseline, week 16, and final time point data. The primary outcome was Kaplan-Meier-estimated weight loss maintenance in each study for up to 204 weeks. Findings: Our analysis included data from 10, 198 particpants (NB=5412; placebo=4786). Proportions of patients with ≥5% or ≥10% weight loss maintenance were numerically higher for NB vs. placebo in all studies and time points. Differences were statistically significant for ≥5% weight loss maintenance in COR-BMOD and COR-I/-II at weeks 52 and 56 and the LIGHT study at weeks 52, 104, and 208. For ≥10% weight loss maintenance, differences were statistically significant in COR-I/COR-II at weeks 52 and 56. Interpretation: These data suggest that NB could be used as part of long-term, comprehensive weight loss and weight loss maintenance strategies. Funding: Orexigen Therapeutics, Inc. and Bausch Health Canada.