THE EFFECT OF THE GASTROINTESTINAL LIPASE INHIBITOR, ORLISTAT, ON SERUM-LIPIDS AND LIPOPROTEINS IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA

The effect of orlistat, a nonabsorbed inhibitor of gastric and pancrea tic lipases, was examined in patients with primary hyperlipidaemia (se rum cholesterol greater than or equal to 16.2 mmol.l(-1) and triglycer ides less than or equal to 5.0 mmol l(-1)) not responsive to dietary c hange alone. In a multicentre, randomised, double-blind study, 103 men and 70 women received 30, 90, 180, or 360 mg of orlistat or placebo f or 8 weeks. Total and low-density lipoprotein cholesterol levels were reduced by 4% and 5% with 30 mg orlistat, by 7% and 8% with 90 mg orli stat, by 7% and 7% with 180 mg orlistat and by 11% and 10% with 360 mg orlistat compared to placebo. High density lipoprotein cholesterol le vels significantly decreased in the 360 mg orlistat group. Triglycerid e levels significantly increased in the placebo group but not in the d rug groups. Body weight decreased by 1.2 kg with 360 mg orlistat, desp ite a weight maintenance diet. Decreases in vitamin E and D levels occ urred, although both vitamins remained within the normal range. Advers e effects from the gastrointestinal tract were frequent, but led to di scontinuation of therapy in only seven patients. Orlistat is a new the rapeutic drug for the treatment of hyperlipidaemia that may be particu larly useful among overweight patients. Its potential place in therapy will await long-term studies. Vitamin supplementation should be consi dered during treatment.