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Bupropion plus Naltrexone for Weight Loss?
Adverse effects were mild-to-moderate and transient.
The history of drug therapy for obesity is littered with compounds that were marginally effective for weight loss but had unacceptable side effects. Most recently, rimonabant was barred from the U.S. market because of serious neuropsychiatric side effects, and sibutramine also is in trouble (JW Gen Med Sep 2 2010). Now, the combination of bupropion and naltrexone is being studied for possible weight-loss effects through its synergistic action on appetite signaling and the mesolimbic reward system.
U.S. investigators randomized 1742 obese patients (85% female; mean body-mass index, 36 kg/m2) without diabetes or cardiovascular disease to fixed-dose combinations of bupropion (180 mg twice daily) and naltrexone (either 8 mg or 16 mg twice daily) or to placebo for 52 weeks (following 4 weeks of dose escalation). The study was supported by a company that has combined the two drugs in a single tablet.
About half of the people in each group withdrew from the study, most commonly during the first 16 weeks. In an intention-to-treat analysis, mean weight loss was significantly greater in the high- and low-dose bupropion/naltrexone groups than in the placebo group (–6.1%, –5.0%, and –1.3%, respectively). Adverse effects in the bupropion/naltrexone groups (e.g., nausea, vomiting, constipation, headache, dizziness, dry mouth) were mostly mild-to-moderate and transient.
Comment: Further studies should include broader populations and head-to-head comparisons of bupropion/naltrexone with other active weight-loss agents. An editorialist warns that known psychiatric and cardiovascular side effects of the two component drugs will require careful evaluation.
Published in Journal Watch General Medicine September 2, 2010
Citation(s):
Greenway FL et al. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): A multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2010 Aug 21; 376:595. (http://dx.doi.org/10.1016/S0140-6736(10)60888-4)
- Medline abstract (Free)
Astrup A. Is cardiometabolic risk improved by weight-loss drugs? Lancet 2010 Aug 21; 376:567. (http://dx.doi.org/10.1016/S0140-6736(10)60999-3)
- Medline abstract (Free)
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- Bupropion/Naltrexone study drop-out rate
Anthony K. Rice, Martinsburg WV, 3 Sep 2010 2:43 PM EST
The participant withdrawal rate seems high. I wonder if this was a result of some unmentioned factor in the study... [more] - Bupropion/Naltrexone study drop-out rate
Rachel G Sagar, 28 Sep 2010 7:44 AM EST
Maybe the ones who were feeling really ill from side effects withdrew! Why else would you withdraw from a study?... [more] - Withdraw maybe disease specific
Rogerio L Coelho, Family Practice - Curitiba Municipal Health System - Brasil, 4 Oct 2010 10:08 AM EST
Why indeed? And why do people quit tehir diets? And why do peple stop their excercise? And why do people... [more]
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