Open-label study of the efficacy, safety, and tolerability of policosanol in patients with high global coronary risk

Abstract

In the present open-label, short-term study the effects of policosanol in the treatment of patients with type II hypercholesterolemia and high global coronary risk were investigated. After dietary stabilization during a 5-week baseline period, 54 patients were instructed to take policosanol 20 mg once daily with the evening meal for 8 weeks. All of the patients had a family history of death caused by coronary artery disease and one or more personal coronary risk factors other than hypercholesterolemia (eg, hypertension [64,8%], previous coronary events [40.7%], smoking [31.5%], and obesity [18.5%]). Fifty percent of the patients were postmenopausal women and 24.1% were men aged >45 years. In addition, 25 patients (46.3%) showed severe hypercholesterolemia (total cholesterol >7.8 mmol/L). At 8 weeks, policosanol significantly reduced low-density lipoprotein cholesterol (LDL-C) (22.6%) and total cholesterol (16.9%) and significantly increased high-density lipoprotein cholesterol (HDL-C) (20.0%). Consequently, the ratios of total cholesterol:HDL-C and LDL-C:HDL-C decreased significantly (25.5% and 29.9%, respectively). Triglycerides did not change significantly after treatment with policosanol. Forty patients (80%) of the 50 patients who completed the study had >15% reductions in LDL-C levels after 8 weeks of therapy. The treatment was well tolerated. No drug-related clinical or blood biochemical adverse effects were detected. Four patients reported mild adverse effects, but none of the patients withdrew from the study because of such effects. The present study suggests that policosanol 20 mg once daily in patients with type II hypercholesterolemia and high global coronary risk was safe, well tolerated, and effective in lowering cholesterol. This highest recommended dosage needs to be studied further among a larger population for a longer duration to make recommendations for lowering cholesterol and to judge the effects of policosanol on the outcomes of patients with global coronary risk.