Abstract

This study was undertaken to investigate the effects of policosanol administered for 1 year on the lipid profile and cardiac events of older hyper-cholesterolaemic patients with coronary heart disease (CHD). 280 older patients of both sexes with type II hypercholesterolaemia and CHD were included. Patients were randomised after 6 weeks of a standard step I cholesterol-lowering diet to treatment with policosanol (5mg) or placebo tablets once daily for 1 year. The starting dose was 5 mg/day, which was doubled to 10 mg/day if predefined goals were not reached after 6 months on therapy. Cardiac events were defined as death from cardiovascular causes [fatal myocardial infarction (MI), sudden cardiac death] and nonfatal MI, unstable angina pectoris or coronary surgery. Policosanol significantly (p < 0.00001) lowered serum low-density lipoprotein-cholesterol (LDL-C) [21.3%], total cholesterol (TC) [15.9%], TC to high-density lipoprotein-cholesterol (HDL-C) ratio [22.7%] and LDL-C/HDL-C ratio (26.1%), as well as triglycerides (7.8%, p < 0.001). HDL-C was significantly increased (18.2%, p < 0.001). The frequency of cardiac events was lower (p < 0.001) in policosanol (1 event, 0.7%) than in placebo (11 events, 7.9%) recipients. Likewise, the frequency of all vascular serious adverse events (four events, 2.9%) and all-cause hospitalisations in the policosanol group (five events, 3.6%) was lower (p < 0.001) than in the placebo group (15 and 20 events, 10.7 and 14.3%, respectively). No patient died during the study. Policosanol was well tolerated. Long-term policosanol is effective in lowering LDL-C and TC and in increasing HDL-C levels in older patients with CHD, and also showed benefits in the occurrence of cardiac events and overall frequency of serious adverse events of vascular aetiology.

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