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KMID : 0388120010100040336
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Journal of Korean Society for the Study of Obesity
2001 Volume.10 No. 4 p.336 ~ p.347
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A Phase 3 Double-blind, Parallel-group, Placebo-controlled Trial of the Efficacy and Safety of Sibutramine(Reductil (R)) in the Treatment of Obese Patients
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Park Cheol-Young
Kim Young-Seoul
Ryu Mee-Sook
Nam Su-Youn
Park Hye-Soon
Kim Sang-Man
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Abstract
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Backgroud: Sibutramine(Reductil (R)) 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 30kg/㎡ or betwwen 27 and 30 with controlled hypertension, diabetes and hyperlipidemia. Ninety-nine 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±3.8kg in the sibutramine group and -1.6±2.6kg in the placebo group. Sibutramine-induced weight loss was not assciated 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.
Conslusion: Overall, the results showed that sibutramine is well tolerated and a sueful, effective therapy for obesity in Korean.
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KEYWORD
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Obesity, Weight loss, Sibutramine
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