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 18-65 y (BMI Z28 kg/m 2 ) were randomized to treatment with orlistat (n ¼ 346) or placebo (n ¼ 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 (À6.570.8 vs À3.070.8%; P ¼ 0.0005). After 12 months, 32.9% of orlistat vs 24.5% of placebo patients lost Z10% of their initial weight (P ¼ 0.04). A significantly greater number of patients receiving orlistat treatment maintained this Z10% weight loss compared to those receiving placebo (28.1 vs 13.8%; Po0.0001). Compared with placebo, orlistat was associated with a greater decrease in fasting blood glucose (À0.8670.12 vs À0.2970.18 mmol/l; Po0.05) and LDL-cholesterol (À13.071.3 vs À7.071.3%; Po0.001). 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.
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