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Only two agents-sibutramine and orlistat-are Food and Drug Administration (FDA)-approved for long-term pharmacotherapy of obesity in the United States. Although there is a growing consensus that pharmacotherapy is appropriate for many individuals who are unable to lose weight through less intensive measures, effective pharmacotherapy is not available for many patients. Current therapies are limited and maintenance of weight loss may be suboptimal ( ( 5)). Obesity is a major global health problem ( ( 1), ( 2)) that contributes significantly to risk for developing coronary artery disease, diabetes, hypertension, as well as premature disability and death ( ( 3), ( 4)). Subjects who completed 48 weeks maintained mean losses of initial body weight of 7.5% and 8.6% for bupropion SR 300 and 400 mg/d, respectively.ĭiscussion: Bupropion SR 300 and 400 mg/d were well-tolerated by obese adults and were associated with a 24-week weight loss of 7.2% and 10.1% and sustained weight losses at 48 weeks. Withdrawals, changes in pulse and blood pressure did not differ significantly from placebo at 24 weeks. placebo = 0.0008) for placebo, bupropion SR 300, and 400 mg/d, respectively. placebo < 0.0001) for placebo, bupropion SR 300, and 400 mg/d, respectively weight losses of ≥10% were 20%, 33%, and 46% ( p vs. The percentages of subjects who lost ≥5% of initial body weight were 46%, 59%, and 83% ( p vs. Compared with placebo, net weight losses were 2.2% ( p = 0.0468) and 5.1% ( p < 0.0001) for bupropion SR 300 and 400 mg/d, respectively. Percentage losses of initial body weight for subjects completing 24 weeks were 5.0%, 7.2%, and 10.1% for placebo, bupropion SR 300, and 400 mg/d, respectively. Results: Of 327 subjects enrolled, 227 completed 24 weeks 192 completed 48 weeks. During a 24-week extension, placebo subjects were randomized to bupropion SR 300 or 400 mg/d in a double-blinded manner. Subjects were counseled on energy-restricted diets, meal replacements, and exercise. Research Methods and Procedures: This 24-week multicenter, double-blind, placebo-controlled study randomized obese adults to placebo, bupropion SR 300, or 400 mg/d. Objective: To critically examine the efficacy of bupropion SR for weight loss.