RESUMO
Orlistat, a gastrointestinal lipase inhibitor, decreases fat absorption and thus it reduces caloric intake. The objectives of this placebo-controlled, double-blind, multicentre trial were to evaluate the efficacy of orlistat in terms of weight reduction, the effects on serum lipid levels and its tolerability profile. 119 obese patients (body mass index, BMI > or = 30 kg/m2) with hyperlipidemia (LDL-cholesterol > or = 4, 2 mmol/l) were randomized to receive either orlistat capsules 120 mg (n = 60) or placebo capsules (n = 59), three times daily, during 24 weeks. All patients were also on a mild hypocaloric diet. Mean weight reduction was 10.75 kg (10.7%) in orlistat group and 7.34 kg (7.5%) in placebo group. All serum lipid parameters improved in the orlistat group. The only adverse event more frequently noted with orlistat was stool fat. Orlistat in combination with diet provides increased weight loss than diet alone, improvements of serum lipids in subjects with hyperlipidemia and it has a good tolerability profile without systemic effects.