Clinical studies

A substantial number of clinical studies have been carried out during short- and long-term administration of policosanol in randomized placebo-controlled study designs that were published.

Short-term studies over a 6- or 8- week period in patients with type II hypercholesterolemia indicated that 10 mg per day would lower total cholesterol by about 13% or 16% and LDL-C by about 18% or 22%, respectively. With 20 mg Policosanol per day, LDL-C can be lowered by about 30%.

Long-term studies performed over a 1-year period and over 2 years with use of 10 mg per day showed that the total and LDL cholesterol-lowering effects are maintained throughout this time period and that the maximal effects are reached after 6 to 8 weeks of treatment.
Of specific interest is the ability of policosanol to increase HDL-C, which has been observed consistently in several studies in patients with type II hypercholesterolemia. Policosanol seems to be superior to both statins and fibrates.

Policosanol does not induce a rebound effect after treatment cessation.

Comparison of simvastatin (10mg per day) with policosanol (10mg per day) in elderly patients with moderate primary hypercholesterolemia showed that both drugs have at these dosages similar efficacy in lowering total cholesterol and LDL-C.

In another short-term study (6 weeks) comparing the efficacy of policosanol (10mg per day) versus pravastatin (10mg per day), the reduction in total cholesterol was similar with both drugs, whereas the decrease in LDL-C and the increase in HDL-C were more pronounced during policosanol treatment.

A study in patients with NIDDM comparing policosanol (10mg per day) with lovastatin (20mg per day) also showed that policosanol was slightly superior in lowering total and LDL cholesterol and increasing HDL-C.

Comparative studies with policosanol versus gemfibrozil, bezafibrate, probucol, and acipimox have been performed. In short, policosanol (10mg per day) was slightly more effective in lowering LDL-C than gemfibrozil (1200mg per day), bezafibrate (400mg per day), probucol (1000mg per day), or acipimox (750mg per day).

A pilot study comparing the effects of bezafibrate alone (400mg per day) versus bezafibrate plus policosanol (10mg per day) showed that the coadministration is safe and that policosanol is able to augment the HDL-C–raising and LDL-C–lowering effects of fibrate monotherapy, whereas the triglyceride-lowering effects could not be augmented.