Naltrexone-Bupropion Positively Affects Body Composition

TOPLINE:

Compared with placebo, extended-release naltrexone-bupropion combination therapy reduced total fat mass and improved the lean-to-fat mass ratio in individuals with obesity or overweight and controlled hypertension, dyslipidemia, or both.

METHODOLOGY:

• Although most weight-loss studies focus on overall body weight or body mass index (BMI) as outcomes, changes in body composition are often overlooked, despite being associated with several key health improvements.
• Researchers conducted a sub-study of the COR-I trial to evaluate the effects of extended-release naltrexone-bupropion on body composition, among participants who underwent dual-energy x-ray absorptiometry (DEXA) at baseline and week 52.
• Participants in CORI-I had either a BMI of 3src-45 and uncomplicated obesity or BMI ≥ 27 with controlled hypertension or dyslipidemia.
• They were randomized to receive either 32 mg of naltrexone with 36src mg of bupropion daily, 16 mg of naltrexone with 36src mg of bupropion daily, or placebo.
• All participants were instructed to follow a hypocaloric diet (5srcsrc kcal deficit per day) and given lifestyle modification advice.
• The primary goal of this sub-study analysis was to assess the absolute change in total fat mass from baseline to week 52; secondary objectives included the assessment of changes in total fat and lean mass from baseline to week 52.

TAKEAWAY:

• Researchers included 82 participants (mean age, 45.6 years; 84.1% women) with comparable baseline characteristics, of whom 56 received naltrexone-bupropion and 26 received placebo.
• At week 52, a significant mean reduction in total body mass was observed in the naltrexone-bupropion group vs the placebo group (7.2 kg vs 2.8 kg; P <.srcsrc1).
• In the naltrexone-bupropion group, total fat mass decreased by 5.src kg and total lean mass by 2.3 kg, whereas the placebo group saw a smaller reductions of 2.src kg and src.8 kg, respectively.
• Due to a larger reduction in fat mass in the naltrexone-bupropion group, the adjusted change in the lean-to-fat mass ratio was src.src69, reflecting a relative gain in lean mass, whereas the placebo group experienced a src.src56 decrease in the ratio, indicating a relative loss of lean mass.

IN PRACTICE:

“Collecting data based on real-world evidence will offer valuable insights into how [naltrexone/bupropion] impacts body composition in a broader and more diverse population, ultimately resulting in improved clinical decision-making,” the authors wrote.

SOURCE:

This study was led by Vanessa Tardio, MD, Royal Victoria Hospital, Montreal, Quebec, Canada, and published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The exploratory nature of this study and its small sample size may have introduced potential bias. The use of DEXA had inherent limitations, such as potential inaccuracies in measuring body fat percentage in individuals with depleted body protein or bone mineral mass. Lack of information on adherence to a hypocaloric diet and increased physical activity prevented the assessment of the contribution of these interventions to the results.

DISCLOSURES:

This study was funded by Bausch Health Canada. Some authors reported receiving speaker honoraria or consulting fees from Bausch Health and other pharmaceutical companies. Two authors reported being employees of and shareholders in Bausch Health Companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.