PMID: 15387958Sep 25, 2004Paper

A multicenter and open study on efficacy and safety of sibutramine in obese subjects

Zhonghua yi xue za zhi
Guang Ning, Coordination Group of Post-Marketing Evaluation of Qumei, Shanghai 200025, China

Abstract

To evaluate the clinical efficacy and safety of sibutramine (Qumei, produced by Fuling Pharmaceutical Factory affiliated to Taiji Group) in obese subjects. The clinical data of 481 obese subjects, with the BMI > 25 kg/m(2), aged 18 approximately 65, in 8 centers treated by sibutramine 10 mg everyday with a low calorie diet for 24 weeks were collected and analyzed. After 24 weeks, study was completed on 429 out of the 481 subjects with a loss-to-follow-up rate of 10.6% and a rejection rate of 0.21%. The average BMI 24 weeks after the study was 28 kg/m(2) +/- 3 kg/m(2), significantly lower than that before the study (29 kg/m(2) +/- 3 kg/m(2)), and the average weight 24 weeks after the study was 73 kg +/- 12 kg, significantly lower than that before the study (78 kg +/- 12 kg), both P < 0.0001. So were the other indexes such as waist circumference, hip circumference, systolic blood pressure, diastolic blood pressure, uric acid, and fasting insulin. The level of high-density lipoprotein was significantly increased. The average heart rate increased from 76 time/min +/- 8 time/min to 77 time/min +/- 7 time/min (P < 0.05). The incidence of adverse events was 35.14%, manifested by thirst (21.41%), constipation (8.32%), dizziness (2.70%)...Continue Reading

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