Sibutramine in weight control: a dose-ranging, efficacy study.
We tested the safety and efficacy of sibutramine, 5 and 20 mg, and placebo on weight loss. Medication was added to caloric restriction, behavior modification, and exercise in a parallel-group, double-blind clinical trial. Participants were 130% to 180% of ideal body weight and in good health. The study lasted 12 weeks over Thanksgiving, Christmas, and New Year's Day. Weight loss during 8 weeks of study medication was: placebo, 1.4 +/- 2.1 kg (n = 19); 5 mg sibutramine, 2.9 +/- 2.3 kg (n = 18); and 20 mg sibutramine, 5.0 +/- 2.7 kg (n = 18) (p less than 0.05 sibutramine, 5 and 20 mg, versus placebo; p less than 0.05 sibutramine, 20 mg versus 5 mg). There is a significant dose-effect relationship. Five participants left the study before completion, all because of adverse events; placebo (one patient), 5 mg sibutramine (one patient), and 20 mg sibutramine (three patients). Sleep difficulties were noted by eight participants (20 mg sibutramine, seven patients; 5 mg, one patient; and placebo, no patients). Six of 21 participants receiving 20 mg complained of irritability, unusual impatience, or "excitation." Sibutramine, 5 and 20 mg, added to a multimodal program assisted participants in losing weight.
Department of Community and Preventive Medicine, University of Rochester School of Medicine and Dentistry, NY.
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Weintraub
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Rubio
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Golik
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Byrne
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Scheinbaum
D000328:Adult; D001521:Behavior Therapy; D001835:Body Weight / Q000187:drug effects*; D003503:Cyclobutanes / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004341:Drug Evaluation; D002149:Energy Intake; D015444:Exercise; D006801:Humans; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy*; D010349:Patient Compliance; D011897:Random Allocation
D003503:Cyclobutanes; C058254:sibutramine