Objective: To evaluate the safety and efficacy of Sibutramine 10 mg per os, once a day in obese patients over a period of 6 months.
Design: A monocenter, double-blind, placebo-controlled, parallel, prospective clinical trial.
Subjects: 109 male and female obese patients (BMI>30 kg/m2) from 16 to 65 y entered the trial.
Measurements: Body weight, body mass index (BMI), waist and waist/hip ratio, medical history, assessment of hunger, satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and ECG.
Results: 40 out of 55 patients in the Sibutramine group and 44 out of 54 patients in the placebo group completed the trial. Using the method of last observation carried forward (LOCF), the weight loss in the Sibutramine group was 7.52 kg (95% confidence intervals (95% CI) 6.15; 8.9) and that in the placebo group was 3.56 kg (95% CI 2.41; 4.7). The BMI loss was 3.14 kg/m2 (95% CI 2.58; 3.69) in the Sibutramine group and 1.46 kg/m2 (95% CI 0.99; 1.93) in the placebo group. The waist reduction was 12. 51 cm (95% CI 9.25; 15.77) in the Sibutramine group and 3.26 cm (95% CI 1.38; 5.14) in the placebo group (P<0.05 by paired Student's t-test for all the intragroup comparisons). 32 Sibutramine patients had 45 adverse events, the most frequent adverse events in the Sibutramine group being dry mouth (n=19), increase in blood pressure (n=5), constipation (n=5) and tachycardia (n=5); 23 placebo patients had 29 adverse events, mainly increase in blood pressure (n=11) and dry mouth (n=10). Two Sibutramine patients withdrew from the trial due to adverse events.
Conclusion: Sibutramine induces significant loss of body weight, BMI and waist, but does not significantly affect cardiovascular function. Sibutramine was well tolerated by most of the patients.