Objective: To evaluate the effects of sibutramine on body weight, body fat mass, metabolism of plasma glucose and serum lipids, and insulin resistance (IR) in primary obesity patients.
Methods: A double-blind, double-placebo, randomized controlled, multi-center clinical trial was conducted. 359 voluntary obese subjects, whose body mass index (BMI) > or = 27 kg/m(2), without hypertension and diabetes, were enrolled. They were randomly divided into group A, B and C respectively. Sibutramine tablets or capsules were administered 10-20 mg/day for 24 weeks to the test groups and placebo to a control group. CT scan was used to measure the intra or subcutaneous-abdominal fat areas (IAFA, SAFA) at L(4)-L(5) level. Dual energy X-ray absorptiometry (DEXA) was used to measure total body fat mass (TBFM).
Results: 315 subjects continued to be followed for 24 weeks. After opening the blind, it was shown that group A received sibutramine tablet (n = 107), group B placebo (n = 104) and group C was capsule (n = 104). In group A and C body weight loss was 4.86 kg (6.42%) and 4.68 kg (6.38%), TBFM reduction was 4.07 kg (13.94%) and 4.09 kg (15.02%), SAFA decreased 7.30% and 7.45%, IAFA decreased 19.21% and 16. 98% respectively. Fasting plasma glucose decreased from 5.69 to 4.83 mmol/L and from 5.38 to 4.69 mmol/L in group A and C respectively. Fasting serum insulin decreased from 20.98 to 14.75 mU/L and from 21.11 to 14.68 mU/L, 2 h insulin decreased from 70.91 to 44.11 mU/L and from 73.13 to 41.93 mU/L in group A and C respectively. Serum triglyceride decreased from 1.98 to 1.73 mmol/L and 1.84 to 1.67 mmol/L, total cholesterol decreased from 5.08 to 4.75 mmol/L and from 5.06 to 4.46 mmol/L, high-density lipoprotein cholesterol increased from 1.13 to 1.28 mmol/L and 1.10 to 1.31 mmol/L in group A and C respectively, HOMA-IR index decreased from 5.32 to 3.32, and from 5.09 to 3.12 respectively in group A and C. Adverse drug reaction was 32.41%, 13.47% and 31.20% in group A, B and C.
Conclusions: Sibutramine tablet or capsule decreases comparably body weight and TBFM, especially IAFA regulates plasma glucose and serum lipid metabolism and also decreases IR. Sibutramine is well tolerated in most of the subjects.