Journal of Obesity & Metabolic Syndrome



J Korean Soc Study Obes 2001; 10(4): 336-347

Published online December 31, 2001

Copyright © Korean Society for the Study of Obesity.

A Phase 3 Double-blind, Parallel-group, Placebo-controlled Trial of the Efficacy and Safety of Sibutramine (Reductil ) in the Treatment of Obese Patients

Cheol Young Park,Young Seol Kim,Mee Sook Ryu,Su Youn Nam1,Hye Soon Park2,Sang Man Kim3

Department of Internal Medicine, Kyung hee and Yonsei1 University School of Medicine, Seoul, KoreaDepartment of Family Medicine, Asan Medical center, University of Ulsan College of Medicine, Seoul, Korea2Department of Family Practice and Community Medicine, Samsung Cheil hospital, Seoul, Korea3


Background: Sibutramine (ReductilⓇ) is a weight control drug that inhibits the reuptake of both serotonin and norepinephrine. This study was performed to evaluate the efficacy and safety of oral treatment with the sibutramine in obese patients.
Methods: This study was 12-week, double blind, multi-center trial following a 2 weeks screening period. The study protocol included a screening visit to assess patient eligibility; a screening period of 2 weeks, a titration period of 4 weeks, and a subsequent 8-week maintenance period. Eligible patients had a body mass index (BMI) greater than 30 kg/m2 or between 27 and 30 with controlled hypertension, diabetes and hyperlipidemia. Ninetynine obese patients were randomized either to sibutramine (50 patients) or placebo (49 patients) at 4 participating centers.
Results: After 12 weeks treatment, sibutramine resulted in significant reduction in weight. Among patients receiving sibutramine, 68.2% of patients lost 5% or more of body weight compared with 13.0% in the placebo group. Mean absolute weight change at 12 weeks was -5.9±3.8 kg in the sibutramine group and -1.6±2.6 kg in the placebo group. Sibutramineinduced weight loss was not associated with significant improvements in serum levels of lipid profile. Most adverse events were mild to moderate in severity and transient. The common adverse events were anorexia, headache, and constipation. Sibutramine group did not increase significantly mean.
Conclusion: Overall, the results showed that sibutramine is well tolerated and a useful, effective therapy for obesity in Korean.

Keywords: Obesity, Weight loss, Sibutramine