Volume 9, Number 8, September 2002

The role of orlistat in the treatment of obese patients with mild to moderate hypercholesterolaemia: consequences for coronary risk
Iain Broom, Elixabeth Hughes, Paul Dodson, John Reckless, on behalf of the Orlistat UK Study Group

This study investigated the effect of orlistat on weight loss and serum lipid parameters in obese patients with hypercholesterolaemia. A total of 215 adult obese patients (body mass index ≥30 kg/m²) with hypercholesterolaemia (total plasma cholesterol ≥6.5 mmol/L or plasma low density lipoprotein cholesterol ≥4.2 mmol/L) were recruited for screening at 12 out-patient clinics in the UK. Of these, 142 patients were randomised to receive double-blind treatment for 24 weeks with orlistat 120 mg (n=71) or placebo (n=71) three times daily in combination with a mildly hypocaloric diet. Patients completing the double-blind phase (orlistat n=42, placebo n=55) were eligible to enter a further 28-week open-label phase and received orlistat 120 mg three times daily in combination with the hypocaloric diet.
Mean weight loss after 24 weeks was 4.4 kg (4.4%) in the orlistat group vs. 2.6 kg (2.5%) with placebo (p<0.01). At the end of the double-blind phase, 44.0% of orlistat-treated patients vs. 18.0% of placebo recipients had lost ≥5% of their initial body weight (p<0.001), and 7.6% vs. 4.2% had lost ≥10% (p=NS). Patients who continued on orlistat during the open-label phase had a mean weight loss of 4.97 kg (4.86%) after 52 weeks. Patients who switched to orlistat had a mean weight loss of 4.28 kg (4.23%). Orlistat was associated with significantly greater reductions than placebo in plasma total cholesterol (-10.88 + 1.36% vs. -3.25 + 1.33%; p<0.001) and LDL-cholesterol (-14.14 + 2.68% vs. -3.68 + 3.61%; p<0.05) during the double-blind phase. Despite similar weight loss at the end of the 52-week period, patients who remained on orlistat throughout the study had greater improvements in plasma lipid concentrations than patients who switched to orlistat after 24 weeks.
Orlistat, in combination with a mildly hypocaloric diet, promotes clinically meaningful weight loss and improvements in lipid concentrations in obese patients with hypercholesterolaemia.

Br J Cardiol 2002;9:460-468.

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