An 8-week, randomized, double-blind study comparing the efficacy and tolerability of
policosanol and
acipimox was conducted in patients with type II
hypercholesterolemia. Prior to entry into active treatment, all patients followed a standard
cholesterol-lowering diet for 12 weeks. Sixty-three patients were randomized to receive either
policosanol (10 mg/day) or
acipimox (750 mg/day)
tablets for 8 weeks under double-blind conditions. Both groups were similar at randomization.
Policosanol significantly reduced total
cholesterol (p < 0.0001) (15.8%),
low-density lipoprotein (
LDL)-cholesterol (21%) and the ratios of
LDL-cholesterol to
high-density lipoprotein (
HDL)-cholesterol (15.8%) and
cholesterol to
HDL-cholesterol (11.5%).
Acipimox significantly lowered both
cholesterol and
LDL cholesterol by 7.5%. The percent 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
transferase levels but only four patients showed increases above the normal limit.
Policosanol significantly reduced
creatinine values (p > 0.05) but no patients had values out of the normal range. Four patients withdrew from the study (two from each group) but none withdrew because of adverse effects. No adverse effects were reported in the
policosanol group, while five patients on
acipimox reported adverse effects (hot flushes,
nausea,
vomiting,
headache, hypochondrial
pain and leg
edema). These results indicate that
policosanol (10 mg/day) was more effective and well tolerated than was
acipimox (750 mg/day) in this study population.