Weight reduction and long-term maintenance after 18 months treatment with orlistat for obesity

OBJECTIVE: To determine the effect of orlistat on weight reduction and the long-term maintenance of this weight loss when associated with a continuous mildly reduced energy diet. DESIGN: A multicenter, 18-month, double-blind study conducted in 81 hospital centers. Patients were randomized to orlistat 120 mg or placebo three times daily in conjunction with a mildly reduced-energy diet maintained throughout the study. SUBJECTS: In total, 696 otherwise healthy, overweight patients aged 18-65y (BMI greater than or equal to 28 kg/m(2)) were randomized to treatment with orlistat (n = 346) or placebo (n = 350). MEASUREMENTS: Body weight, anthropometry, lipid and glycemic control parameters and blood pressure. RESULTS: After 18 months, patients treated with orlistat lost significantly more body weight compared with placebo (-6.5 +/- 0.8 vs -3.0+/-0.8%; P=0.0005). After 12 months, 32.9% of orlistat vs 24.5% of placebo patients lost greater than or equal to 10% of their initial weight (P=0.04). A significantly greater number of patients receiving orlistat treatment maintained this greater than or equal to 10% weight loss compared to those receiving placebo (28.1 vs 13.8%; P<0.0001). Compared with placebo, orlistat was associated with a greater decrease in fasting blood glucose (-0.86+/-0.12 vs -0.29+/-0.18mmol/l; P<0.05) and LDL-cholesterol (-13.0+/-1.3 vs -7.0+/-1.3%; P<0.001). CONCLUSION: A clinically meaningful reduction in body weight and the maintenance of this weight loss is achievable with orlistat treatment and dietary restriction over a period of 18 months. This weight loss resulted in an improvement in risk factors for coronary heart disease.