Efficacy and tolerability of policosanol compared with lovastatin in patients with type II hypercholesterolemia and concomitant coronary risk factors

Objective: This randomized, double-blind study was undertaken to compare the efficacy and tolerability of policosanol 10 mg/d and lovastatin 20 mg/d in patients with type II hypercholesterolemia who were at high risk for coronary events. Methods: After 4 weeks on a lipid-lowering diet, 59 patients who met study conduct criteria were assigned randomly to receive, in a double-blind trial, policosanol or lovastatin tablets QD for 12 weeks. Results: Policosanol significantly (P < 0.00001) reduced low-density lipoprotein cholesterol (LDL-C) (32.4%), total cholesterol (TC) (22.4%), and the ratios of LDL-C/high-density lipoprotein cholesterol (HDL-C) (39.3%) and TC/HDL-C (32.0%). Lovastatin significantly (P < 0.0001) reduced LDL-C (27.6%), TC (19.8%), and the ratios (P < 0.001) of LDL-C/HDL-C (32.8%) and TC/HDL-C (25.2%). Policosanol significantly (P < 0.05) increased levels of HDL-C (14.3%); lovastatin treatment did not significantly affect HLC-C levels. Between-group comparisons thus showed that policosanol was more effective (P < 0.05) than lovastatin in reducing the LDL-C/HDL-C HDL-C ratio and increasing HDL-C levels. Both treatments were well tolerated. Lovastatin significantly (P < 0.05) increased creatine kinase levels; individual values in both groups, however, remained within normal limits. Two patients receiving lovastatin discontinued the study because of moderate adverse experiences (rash and gastrointestinal disturbances). No patient in the policosanol group withdrew from the study. Conclusions: We concluded that policosanol 10 mg/d and lovastatin 20 mg/d were similarly effective and well tolerated in treating patients with type II hypercholesterolemia and concomitant multiple coronary risk factors. Modest advantages were shown with regard to the changes in HDL-C levels and the LDL-C/HDL-C ratio.