OBJECTIVETo evaluate the effects and safety of policosanol combined with simvastatin on serum lipids and sex hormones in male patients with hyperlipidemia.

METHODSThis randomized, single-blinded, placebo-controlled study included 120 male patients with hyperlipidemia. Patients were divided randomly into treatment group(n = 60) and control group(n = 60). Patients in the treatment group were administrated with simvastatin (40 mg/d) plus policosanol (20 mg/d),and those in the control group were treated with simvastatin (40 mg/d) plus placebo (20 mg/d). The values of total cholesterol(TC), triglyceride(TG), high density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol(LDL-C), testosterone(T) and estradiol (E2) were assessed before and after 16 weeks treatment.Drug-induced adverse effects were observed.

RESULTSBaseline characteristics were similar between groups. TC,TG, LDL-C were (5.74 ± 0.99) , (1.62 ± 0.69), (3.60 ± 0.56) mmol/L in the treatment group at baseline and significantly reduced after 16 weeks treatment (4.57 ± 0.58), (1.54 ± 0.55), (2.68 ± 0.38) mmol/L (all P < 0.05). TC, LDL-C were (5.99 ± 0.93) , (3.76 ± 0.42) mmol/L in the control group at baseline and significantly reduced after 16 weeks treatment (5.03 ± 0.59) , (2.98 ± 0.28) mmol/L (all P < 0.05) while TG remained unchanged post 16 weeks therapy in the control group. Simvastatin plus policosanol achieved a significantly greater reduction in LDL-C and TC than simvastatin plus placebo (P < 0.05). HDL-C,T and E2 were similar before and after 16 weeks treatments in both groups (P > 0.05) .The adverse reactions were similar between the two groups, most of them were mild and happened at the beginning of drug therapy and could be well tolerated.

CONCLUSIONSimvastatin/policosanol produces greater decreases in TC, LDL-C than simvastatin/placebo without resulting more side effects and changes on sex hormones.