A long-term, open-label study of the efficacy and tolerability of policosanol in patients with high global coronary risk

In the present long-term, open-label study, the effects of policosanol (20 mg/d) were investigated in the treatment of type II hypercholesterolemia in patients with high global coronary risk. After dietary stabilization during a 5-week baseline period, 68 patients took policosanol 20 mg once daily with the evening meal for 12 months. All of the patients had nonlipid coronary risk factors, such as a family history of coronary disease (88.2%), hypertension (70.6%), previous coronary events (60.3%), and severe hypercholesterolemia (total cholesterol >7.8 mmol/L) (60.3%). After 2 months of treatment with policosanol, low-density lipoprotein cholesterol (LDL-C) and total cholesterol decreased significantly (P < 0.00001) by 24.7% and 15.9%, respectively, and high-density lipoprortein cholesterol (HDLC) increased significantly (P < 0.0001) by 31.1%. The ratios of total cholesterol to HDL-C and LDL-C to HDL-C decreased significantly (P < 0.00001) by 29.3% and 37.8%, respectively. These effects continued to increase, although moderately, during the 12-month follow-up. At the end of the study, reductions were noted in total cholesterol (30.0%), LDL-C (44.8%), total cholesterol to HDL-C ratio (54.1%), and LDL-C to HDL-C ratio (62.7%), whereas HDL-C increased by 68.5%. Triglycerides, which decreased significantly from 4 until 12 months, were 21.2% lower at 12 months than at baseline. Of 59 patients who completed the study, 56 (94.9%) had reductions in LDL-C greater than or equal to 15% at study completion. The treatment was well tolerated; no drug-related clinical or biochemical adverse effects (AEs) were detected. None of the patients withdrew from the study because of AEs, and only 4 patients reported mild AEs during the study. Results of the present study show that policosanol 20 mg once daily for 1 year was effective and well tolerated in patients with type II hypercholesterolemia and high global coronary risk.