• Am. J. Med. · Feb 1999

    Randomized Controlled Trial Clinical Trial

    Long-term maintenance of weight loss after a very-low-calorie diet: a randomized blinded trial of the efficacy and tolerability of sibutramine.

    • M Apfelbaum, P Vague, O Ziegler, C Hanotin, F Thomas, and E Leutenegger.
    • Nutrition Department, Bichat Hospital, Paris, France.
    • Am. J. Med. 1999 Feb 1; 106 (2): 179184179-84.

    BackgroundVery-low-calorie diets are a well established method to achieve substantial short-term weight loss in obese patients, but long-term maintenance of the weight loss is very disappointing. A combined very-low-calorie diet and pharmacologic approach could be an effective means of prolonging its benefits.Patients And MethodsEligible patients had a body-mass index greater than 30 kg/m2; those who lost 6 kg or more during a 4-week treatment with a very-low-calorie diet were randomly assigned to 1 year of treatment with sibutramine (10 mg) or identical placebo.ResultsIn an intention-to-treat analysis, mean (+/-SD) absolute weight change at 1 year (or study endpoint) was -5.2 (+/-7.5) kg in the 81 patients in the sibutramine group and +0.5 (+/-5.7) kg in the 78 patients in the placebo group (P = 0.004). When compared with their weight at study entry (before the very-low-calorie diet), 86% of patients in the sibutramine group had lost at least 5% of their weight, compared with only 55% of those in the placebo group (P <0.001) at the study endpoint. Similarly, at month 12, 75% of subjects in the sibutramine group maintained at least 100% of the weight loss achieved with a very-low-calorie diet, compared with 42% in the placebo group (P <0.01).ConclusionFollowing a very-low-calorie diet, sibutramine is effective in maintaining and improving weight loss for up to 1 year.

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