[Sibutramine--antidepressive agent tested against obesity]

Abstract

Eight European centers recruited 605 obese patients (BMI 30-45 kg/m2) for a six month period of weight loss with sibutramine (10 mg/d) combined with an individualized 600 kcal/d deficit. 467 (77%) patients with > 5% weight loss were then randomized to sibutramine (10 mg/day) and placebo groups over a further 18 months. Initially weight loss progressed to a total of -11.3 +/- 5.5 kg. After randomization the placebo group regained weight to -4.7 +/- 7.2 kg from baseline at 2 years; the sibutramine group only showed slight weight regain to -10.2 kg +/- 9.3 kg (mean group difference 5.5 kg, 95% C.I. 2.9, 8.1, p < 0.001). VLDL fell and HDL increased more than expected by weight loss. Twenty (3%) patients were withdrawn because of increases in blood pressure. This individualized management program achieves metabolically significant and sustained weight loss in 77% of obese patients.