Weight Loss With Naltrexone SR/Bupropion SR Combination Therapy as an Adjunct to Behavior Modification: The COR‐BMOD Trial |
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| Authors: | Thomas A Wadden John P Foreyt Gary D Foster James O Hill Samuel Klein Patrick M O'Neil Michael G Perri F Xavier Pi‐Sunyer Cheryl L Rock Janelle S Erickson Holly N Maier Dennis D Kim Eduardo Dunayevich |
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| Institution: | 1. Department of Psychiatry, Center for Weight and Eating Disorders, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA;2. Department of Medicine, Baylor College of Medicine, Houston, Texas, USA;3. Department of Medicine, Center for Obesity Research and Education, Temple University, Philadelphia, Pennsylvania, USA;4. Department of Pediatrics, Center for Human Nutrition, University of Colorado at Denver and Health Sciences Center, Denver, Colorado, USA;5. Department of Medicine, Washington University School of Medicine, St Louis, Missouri, USA;6. Department of Psychiatry and Behavioral Sciences, Weight Management Center, Medical University of South Carolina, Charleston, South Carolina, USA;7. Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, Florida, USA;8. Department of Medicine, Obesity Research Center, St Luke's‐Roosevelt Hospital Center, New York, New York, USA;9. Department of Family and Preventive Medicine, School of Medicine, University of California, San Diego, California, USA;10. inVentiv Clinical Solutions, LLC, Houston, Texas, USA;11. Orexigen Therapeutics, Inc., La Jolla, California, USA |
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| Abstract: | This 56‐week, randomized, placebo‐controlled trial examined the efficacy and safety of naltrexone plus bupropion as an adjunct to intensive behavior modification (BMOD). A total of 793 participants (BMI = 36.5 ± 4.2 kg/m2) was randomly assigned in a 1:3 ratio to: (i) placebo + BMOD (N = 202); or (ii) naltrexone sustained‐release (SR, 32 mg/day), combined with bupropion SR (360 mg/day) plus BMOD (i.e., NB32 + BMOD; N = 591). Both groups were prescribed an energy‐reduced diet and 28 group BMOD sessions. Co‐primary end points were percentage change in weight and the proportion of participants who lost ≥5% weight at week 56. Efficacy analyses were performed on a modified intent‐to‐treat population (ITT; i.e., participants with ≥1 postbaseline weight while taking study drug (placebo + BMOD, N = 193; NB32 + BMOD, N = 482)). Missing data were replaced with the last observation obtained on study drug. At week 56, weight loss was 5.1 ± 0.6% with placebo + BMOD vs. 9.3 ± 0.4% with NB32 + BMOD (P < 0.001). A completers analysis revealed weight losses of 7.3 ± 0.9% (N = 106) vs. 11.5 ± 0.6% (N = 301), respectively (P < 0.001). A third analysis, which included all randomized participants, yielded losses of 4.9 ± 0.6 vs. 7.8 ± 0.4%, respectively (P < 0.001). Significantly more NB32 + BMOD‐ vs. placebo + BMOD‐treated participants lost ≥5 and ≥10% of initial weight, and the former had significantly greater improvements in markers of cardiometabolic disease risk. NB32 + BMOD was generally well tolerated, although associated with more reports of nausea than placebo + BMOD. The present findings support the efficacy of combined naltrexone/bupropion therapy as an adjunct to intensive BMOD for obesity. |
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