Policosanol Deemed Ineffective Treatment For Excessive Blood Lipids

COLOGNE, Germany--The sugar cane derivative policosanol may not have significant lipid-lowering effects compared to placebo, according to a study published in the Journal of the American Medical Association (JAMA) (295, 19:2262-69, 2006).

Using patients from lipid outpatient clinics and general practitioners in Germany, researchers from the University of Cologne, conducted a multicenter, randomized, double blind, placebo-controlled, parallel-group trial to test for possible dose-dependent lipid-lowering effects of policosanol. Subjects enrolled in the trial had hypercholesterolemia or combined hyperlipidemia, with either baseline low-density lipoprotein cholesterol (LDL) levels of at least 150 mg/dL ( 3.88 mmol/L) and no more than one cardiovascular risk factor other than diagnosed coronary heart disease, or baseline LDL levels of between 150 and 189 mg/dL (3.88-4.89 mmol/L) and two or more risk factors. The intervention period consisted of an open-label, six-week placebo and diet run-in phase followed by a double blind, 12-week treatment phase after randomization of the patients (n=143) to five groups: 10, 20, 40 or 80 mg/d of policosanol or placebo. The primary end point was percentage change in LDL; secondary outcomes included changes in other lipoproteins including total cholesterol, high-density lipoprotein cholesterol (HDL), very low-density lipoprotein cholesterol (VLDL), triglycerides, lipoprotein(a) and the ratio of total or LDL to HDL.

Although policosanol was tolerated well and there were no serious adverse events, the results showed LDL levels did not decrease more than 10 percent from baseline in any of the five groups; no statistically significant difference between policosanol and placebo was observed. A nonparametric test analyzing dose-dependency also failed to yield significant results. In addition, the researchers found policosanol had no significant effects in any of the secondary outcome measures. Policosanol was tolerated well without serious adverse events.

It was concluded sugar cane-derived policosanol in usual and high doses does not demonstrate a reduction in lipid levels beyond placebo. The researchers noted the results contradict those of more than 80 placebo-controlled or comparative trials, most of which were performed by a single research institute, which suggested 5 to 40 mg/d doses of policosanol have lipoprotein-lowering effects comparable with statins.

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