Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors

Introduction: This study was undertaken to evaluate the efficacy, safety an d tolerability of policosanol, a new cholesterol-lowering drug, in patients with type II hypercholesterolemia and additional coronary risk factors. Patients and methods: After 5 weeks of a standard step-1 lipid-lowering die t, 437 patients were randomized to receive, under double-blind conditions, 5 mg policosanol or placebo once a day with the evening meal for 12 weeks a nd 10 mg policosanol or placebo for the next 12 weeks, Results: Both groups were similar at randomization, Policosanol (5 and 10 m g/day) significantly reduced (P < .001) serum low-density lipoprotein chole sterol (18.2% and 25.6%, respectively) and cholesterol (13.0% and 17.4%), a nd it significantly raised (P < .01) high-density lipoprotein cholesterol ( 15.5% and 28.4%). Triglycerides remained unchanged after the first 12 weeks and lowered significantly (5.2%; P < .01) at study completion, Policosanol was safe and well tolerated, and no drug-related disturbances were observe d. Two male patients who received placebo died during the study-one because of a myocardial infarction and the other because of a cardiac arrest that occurred during a surgical intervention, There were 11 serious adverse even ts (5.1%) in 10 patients who received placebo (4.6%), 7 of which were vascu lar, compared with no serious adverse events reported in patients receiving policosanol (P < .01). Conclusions: Subjects in the group treated with policosanol did not have se rious adverse events during the 24-week study. This study shows that polico sanol is effective, safe, and well tolerated in patients with hypercholeste rolemia and concomitant coronary risk factors.