Sibutramine Plus Meal Replacement Therapy for Body Weight Loss and Maintenance in Obese Patients
Article first published online: 6 SEP 2012
2007 North American Association for the Study of Obesity (NAASO)
Volume 15, Issue 6, pages 1464–1472, June 2007
How to Cite
Early, J. L., Apovian, C. M., Aronne, L. J., Fernstrom, M. H., Frank, A., Greenway, F. L., Heber, D., Kushner, R. F., Cwik, K. M., Walch, J. K., Hewkin, A. C. and Blakesley, V. (2007), Sibutramine Plus Meal Replacement Therapy for Body Weight Loss and Maintenance in Obese Patients. Obesity, 15: 1464–1472. doi: 10.1038/oby.2007.175
- Issue published online: 6 SEP 2012
- Article first published online: 6 SEP 2012
- Received for review March 24, 2006, Accepted in final from December 11, 2006
- clinical management;
- behavior modification;
- risk factor;
- meal replacement
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 ≥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 ∼1200–1500) or daily placebo + three low-calorie meals (total kcal/d ∼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 ≥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 ≥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.