A comparative study of policosanol versus acipimox in patients with type II hypercholesterolemia

An B-week, randomized, double-blind study comparing the efficacy and tolera bility of policosanol and acipimox was conducted in patients with type II h ypercholesterolemia. Prior to entry into active treatment, all patients fol lowed a standard cholesterol-lowering diet for 12 weeks. Sixty-three patien ts were randomized to receive either policosanol (10 mg/day) or acipimox (7 50 mg/day) tablets for 8 weeks under double-blind conditions. Both groups w ere similar at randomization. Policosanol significantly reduced total chole sterol (p <0.0001) (15.8 %), low-density lipoprotein (LDL)-cholesterol (21% ) and the ratios of LDL-cholesterol to high-density lipoprotein (HDL)-chole sterol (15.8%) and cholesterol to HDL-cholesterol (11.5%). Acipimox sig sig nificantly lowered both cholesterol and LDL cholesterol by 7.5%. The percen t changes of total cholesterol, LDL-cholesterol and both ratios were larger in the policosanol group than in the acipimox group. Both drugs were well tolerated Acipimox significantly increased (p >0.001) aspartate amino trans ferase levels but only four patients showed increases above the normal limi t. Policosanol significantly reduced creatinine values (p >0.05) but no pat ients had values out of the normal range. Four patients withdrew from the s tudy (two from each group) but none withdrew because of adverse effects. No adverse effects were reported in the policosanol group, while five patient s on acipimox reported adverse effects (hot flushes, nausea, vomiting, head ache, hypochondrial pain and leg edema). These results indicate that polico sanol (10 mg/day) was more effective and well tolerated than was acipimox ( 750 mg/day) in this study population.