ONE-YEAR STUDY OF THE EFFECT OF POLICOSANOL ON LIPID PROFILE IN PATIENTS WITH TYPE-II HYPERCHOLESTEROLEMIA

A 1-year, double-blind, placebo-controlled study of the efficacy, safe ty, and tolerability of policosanol 5 mg twice a day was conducted in 97 patients with type II hypercholesterolemia whose total and low-dens ity lipoprotein (LDL) cholesterol was inadequately controlled by diet. After 2 months of policosanol therapy, significant reductions in tota l and LDL cholesterol were noted that persisted during the 1-year foll ow-up. Twelve months after therapy, LDL-C and total cholesterol decrea sed by 27.5% and 16.3%, respectively. Ratios of LDL to high-density li poprotein (HDL) and total cholesterol to HDL were also significantly d ecreased after 2 months; reductions of 37.1% and 28%, respectively, we re apparent 1 year after treatment. HDL increased during the study, bu t the increase (25.9%) reached statistical significance only after 12 months of therapy. Triglycerides changed nonsignificantly compared wit h baseline and placebo. Six patients (4 from the placebo group and 2 f rom the policosanol group) withdrew from the trial; no patient withdre w because of adverse experiences. No drug-related clinical or biochemi cal disturbances were observed. Adverse experiences reported were mild and transient and did not differ significantly from those seen with p lacebo. Policosanol (10 mg/d) administered for 1 year showed sustained efficacy, as well as very good safety and tolerability.