Long-term Effects with Policosanol on Lipid Profile According to Hypercholesterolemia Severity in Older Patients

Background: End-point based studies have demonstrated a direct relationship between coronary disease and elevated serum levels of low density lipoprotein cholesterol (LDL-C) and total cholesterol, as well as the benefits of lowering LDL-C with statins on clinical end-points. Policosanol is a mixture of very long chain fatty alcohols purified from sugar cane wax, with dislipidemia controlling effects, proved in numerous clinical assays in which patients with different conditions were included. The efficacy and tolerability of policosanol in the elderly have been also investigated in several clinical trials, being effective, safe and well tolerated. Objectives: To investigate the effects of policosanol treatment during three years on lipid profile with a proportional intensity to the initial dislipidemia severity in older hypercholesterolemic patients. Methods: The present analysis was obtained from the data of all patients treated with policosanol included in a previous prevention study. One thousand, ford hundred seventy old patients of both sexes, between 60 to 85 years old, with type II hypercholesterolemia, and ³ 1 non-lipid coronary risk factors, were randomized in two groups and treated with policosanol or placebo, during three years. Significant changes on lipid profile with a proportional intensity to the initial dislipidemia severity were considered primary efficacy variables. The analysis was done by Intention-to-treat method. Results: An analysis of the response intensity show that after treatment, reductions of LDL-C, total cholesterol and triglycerides were greater, and according to the initial hypercholesterolemia severity, so that, patients with severe hypercholesterolemia showed the better responses, followed by moderate and mild hypercholesterolemia. An opposite pattern, however, was observed for HDL-C serum concentration. Triglycerides did not respond in the same way. The frequency of vascular serious adverse events was lower in the policosanol group (15 events) compared with those on placebo group (49 events). There were 109 patients who experienced serious adverse events: 83 (11.3 %) in placebo and 26 (3.5 %) in policosanol group (p<0.0001). Twenty-three deaths occurred up to study completion: 19 patients belonging to placebo group (2.6 %) and 4 to the policosanol group (0.5 %). Conclusions: The treatment with policosanol produce positive changes on serum lipid profile according to hypercholesterolemia severity and with a significant lower amount of vascular serious adverse events, mortality, and frequency of total adverse events in older patients.