Effects of orlistat on obesity-related diseases – a six-month randomized trial

Aim:  To assess the effect of orlistat on body weight and concomitant diseases in patients with body mass index (BMI) of > 28 kg/m2 and poorly controlled type 2 diabetes, hypertension or hypercholesterolaemia. Methods:  This trial was a six-month, randomized, double-blind, placebo-controlled study of orlistat 120 mg three times daily plus a mildly reduced-calorie diet. 1004 obese patients (BMI 28–40 kg/m2) were included by 253 private endocrinologists and received orlistat (n = 499) or placebo (n = 505). Patients were stratified by concomitant disorder (type 2 diabetes, n = 193; hypertension, n = 614; hypercholesterolaemia, n = 197). Body weight, anthropometry, lipid and glycaemic control parameters and blood pressure. Results:  After six months, orlistat produced a significantly greater weight loss than placebo in type 2 diabetes (−4.2% vs. −1.4%), hypertension (−6.2% vs. −1.9%) and hypercholesterolaemia (−5.5% vs. −2.3%) groups (p < 0.0001 for all). There was a greater decrease in HbA1c in the type 2 diabetes group (−0.54 vs. −0.18%; p = 0.002) and low-density lipoprotein (LDL)-cholesterol in the hypercholesterolaemia group (−11.7% vs. −4.5%; p = 0.004) with orlistat vs. placebo. Early weight loss (≥ 5% at 12 weeks) was associated with the highest weight loss in each group, and the highest decreases in HbA1c, LDL-cholesterol and diastolic blood pressure in patients with type 2 diabetes, hypercholesterolaemia and hypertension, respectively, at six months. The incidence of adverse events was similar for orlistat and placebo, except for certain generally well-tolerated gastrointestinal events that were more common with orlistat. Conclusion:  Orlistat plus a mildly reduced-calorie diet produced clinically meaningful weight loss and improvements in risk factors in overweight and obese patients with poorly controlled type 2 diabetes, hypertension or hypercholesterolaemia.