Background: Policosanol, commonly derived from purified sugar cane wax, has been reported to exert lipid-lowering effects. Policosanol is available in the United States as a nutritional supplement despite no US research clinical experience. This trial was designed to rigorously establish the lipid-lowering efficacy of policosanol as monotherapy and its potential additive and possibly synergistic effects when added to statin therapy.
Methods: A randomized, parallel, double-blind, double-dummy, placebo-controlled design was used. Patients with low-density lipoprotein cholesterol (LDL-C) levels from 140 to 189 mg/dL were assigned into 1 of 4 groups to receive policosanol 20 mg, atorvastatin 10 mg, combination therapy, or placebo for 12 weeks.
Results: A total of 99 patients were examined. Baseline characteristics were similar among all treatment groups. Policosanol (20 mg/d for 12 weeks) did not significantly change plasma total cholesterol, LDL-C, high-density lipoprotein cholesterol, or triglyceride levels when compared with baseline values or with values of placebo-treated patients. Atorvastatin (10 mg/d for 12 weeks) reduced total cholesterol by 27% and LDL-C by 35%. Addition of policosanol to atorvastatin failed to produce any further reduction in lipid levels above that of atorvastatin alone. Policosanol was safe and did not affect liver enzyme or creatinine phosphokinase levels.
Conclusions: Policosanol did not reduce LDL-C or total cholesterol levels either alone or in combination with atorvastatin. This observation supports the need for systematic evaluation of available products containing policosanol to determine their clinical lipid-lowering efficacy under rigorous experimental conditions. We propose that policosanol should be added to the list of nutritional supplements lacking scientific validity to support their use.