The effect of orlistat on body weight and coronary heart disease risk profile in obese patients: The Swedish Multimorbidity Study

Objective. To assess the effect of orlistat on body weight and cardiovascul ar risk amongst obese patients at high coronary risk. Design. After screening, patients entered a two-week single-blind placebo l ead-in period, during which they followed a mildly hypocaloric diet, before being randomized to double-blind treatment with either orlistat 120 mg or placebo three times daily, in conjunction with dietary intervention for 1 y ears. Setting. The study was conducted at 33 primary care centres in Sweden. Subjects. A total of 382 obese adults (body mass index 28-38 kg m(-2)) with type 2 diabetes, hypercholesterolaemia and/or hypertension were recruited. of whom 376 were randomized to orlistat (n = 190) or placebo (n = 186). Main outcome measures. Change in body weight, waist and hip circumferences, blood pressure, serum lipid profile, fasting glucose and HbA1c. Results. After 1 years, mean weight loss was significantly greater with orl istat compared with placebo (5.9% vs. 4.6%: P<0.05). Moreover, significantl y more orlistat-treated patients than placebo recipients maintained weight loss of greater than or equal to 5% (54.2% vs. 40.9%; P<0.001). Orlistat wa s also associated with significantly greater improvements than placebo in t otal serum cholesterol (- 3.3% vs. -0.5%; P < 0.05), LDL-cholesterol (- 7.0 % vs. -1.1%; P< 0.05), fasting glucose (5.1% vs. -0.1% P < 0.01) and HbA1c (- 2.7% vs. -0.5%; P(0.05). Similar results were reported for the subgroup of patients with type 2 diabetes. Orlistat was well tolerated. Conclusions. Treatment with orlistat in conjunction with diet promotes sign ificantly greater weight loss and cardiovascular risk factor reduction than diet alone amongst obese patients at high risk of future coronary events.