Abstract 4134: Beeswax Policosanol Failed to Demonstrate Lipid-Altering Effects in Well-Controlled Clinical Trials
Policosanols originating from various plant sources are marketed as cholesterol-lowering dietary supplements in the US. Their beneficial effect on serum lipids is derived from published studies emanating from a limited number of research centers. These studies reported that the lipid-altering effects of sugar cane policosanol 5–20 mg/daily were comparable to low dose statins. We completed 4 clinical trials with beeswax policosanol (BWP) to assess its lipid-lowering effect in subjects with mild-to-moderate hyperlipidemia (Table⇓). Policosanol 10 mg daily was evaluated in 2 randomized, double blind, placebo controlled studies, identical in design (Studies 1 & 2). Efficacy parameters included the percent changes in LDL-C, HDL-C, total cholesterol, non-HDL-C, LDL-C/ HDL-C ratio, and triglycerides from baseline to end of study. After 13 weeks of treatment, a daily dose of BWP 10 mg failed to demonstrate a lipid-altering effect versus placebo in either study. The safety profile was comparable for both treatment groups. We conducted 2 additional studies with new formulations of BWP at a daily dose of 40 mg to ascertain whether the previous trials failed due to insufficiency of the test dose or the formulation used. A new tablet formulation was evaluated in a double blind, placebo controlled study (Study 3). An oil-dispersion formulation of BWP in 2 x 20 mg softgel capsules was assessed in a separate group of subjects in an open label trial (Study 4). After 6 weeks of treatment, neither study showed a lipid-lowering effect of BWP 40 mg.
Conclusion: Beeswax policosanol 10 mg or 40 mg daily in tablet or softgel formulations has no effect on serum lipids in subjects with mild-to-moderate hypercholesterolemia. Given recent publications showing negligible effects of wheat germ and sugar cane derived policosanols, these data raise the question of whether policosanol of any origin has a beneficial effect on serum lipids.