Abstract

OBJECTIVE:

Our objective was to assess the efficacy and safety of sibutramine with a low-calorie diet (LCD) and commercial meal-replacement product in achieving weight loss and weight-loss maintenance in obese patients.

RESEARCH METHODS AND PROCEDURES:

Eight U.S. centers recruited 148 obese patients for a 3-month comprehensive weight-loss therapy (Phase I) comprising daily sibutramine 10 mg + LCD (two Slim-Fast meal-replacement shakes, one low-calorie meal; total kcal/d = 1200-1500). Patients (N = 113) who lost > or =5% of initial body weight during Phase I were randomized for a 9-month period (Phase II) to daily sibutramine 15 mg + LCD (one meal-replacement shake; two low-calorie meals: total kcal/d approximately 1200-1500) or daily placebo + three low-calorie meals (total kcal/d approximately 1200-1500). Both phases included behavior modification. Efficacy was assessed by body weight change during each phase and by the number of patients at endpoint maintaining > or =80% of the weight they had lost by the end of Phase I. Other outcomes included changes in cardiovascular and metabolic risk factors, adverse events, and vital signs.

RESULTS:

Mean body weight change during Phase I was -8.3 kg (p < 0.001). Patients randomized to sibutramine in Phase II had an additional -2.5 kg mean weight loss vs. a 2.8-kg increase in the placebo group (p < 0.001). More sibutramine patients maintained > or =80% of their Phase I weight loss at the end of Phase II (85.5% vs. placebo 36.7%, p < 0.001). Most adverse events were mild or moderate in severity, and all serious adverse events were unrelated to sibutramine.

DISCUSSION:

Sibutramine plus LCD with meal replacements and behavior modification is a safe and effective strategy for achieving and sustaining weight loss in obese patients.