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

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%) and poor sleeping (2.49%). Seven subjects were lost in the end because of adverse events.

Sibutramine of the dosage of 10 mg/day is an effective and safe therapy for weight reduction in obese subjects. Most adverse events of sibutramine are mild and tolerable.