Zhonghua yi xue za zhi · 2004
[A multicenter and open study on efficacy and safety of sibutramine in obese subjects].
Клиническое исследованиеАннотация на английскомСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Ning Guang, Coordination Group of Post-Marketing Evaluation of Qumei, Shanghai 200025, China
Аннотация
OBJECTIVE: To evaluate the clinical efficacy and safety of sibutramine (Qumei, produced by Fuling Pharmaceutical Factory affiliated to Taiji Group) in obese subjects.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.