A clinical trial of the use of Sibutramine for the treatment of patients suffering essential obesity

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, prospecti ve clinical trial. SUBJECTS: 109 male and female obese patients (BMI > 30 kg/m(2)) 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, stand ard laboratory assessments, blood pressure, heart rate and EGG. RESULTS: 40 out of 55 patients in the Sibutramine group and 44 out of 54 pa tients in the placebo group completed the trial. Using the method of last o bservation 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/m(2) (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 plac ebo group (P < 0.05 by paired Student's t-test for all the intragroup compa risons). 32 Sibutramine patients had 45 adverse events, the most frequent a dverse 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) an d 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 wa ist, but does not significantly affect cardiovascular function. Sibutramine was well tolerated by most of the patients.