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(Circulation. 2006;114:II_223.)
© 2006 American Heart Association, Inc.

Lipid and Lipoprotein Metabolism: Clinical III

Abstract 1191: Cuban Sugar Cane Policosanol does not Influence Serum Lipoprotein Concentrations in Subjects with Hyperlipidemia

Heiner K Berthold¹; Ioanna Gouni-Berthold²

¹ Drug Commission of the German Med Association, Berlin, Germany
² Dept. of Internal Medicine II, Univ of Cologne, Cologne, Germany

Context: Policosanol, a natural substance derived from sugar cane, is advertised for its lipid-lowering effects as a non-prescription drug. More than 70 placebo-controlled or comparative trials, performed mostly by a Cuban state research institute, suggest that it has at doses of 5– 40 mg per day lipid-lowering effects comparable to those of statins.

Objective: To determine the lipid-lowering effects of Cuban policosanol and to establish, if effective, dose-dependency up to 80 mg per day in white subjects with hypercholesterolemia or combined hyperlipidemia.

Design, Setting, and Participants: Multi center (lipid outpatient clinics and general practitioners), randomized, double-blind, placebo-controlled, parallel group trial (5 treatment groups). Patients with hypercholesterolemia or combined hyperlipidemia having baseline LDL cholesterol (LDL-C) levels >150 mg/dL (3.88 mmol/L) and either no or one cardiovascular risk factor, or two or more risk factors with LDL-C levels between 150 and 190 mg/dL (3.88 and 4.89 mmol/L).

Interventions: Open-label 6 weeks placebo and diet run-in phase followed by a double-blind 12 weeks treatment phase after randomization to five groups: 10 mg, 20 mg, 40 mg, or 80 mg per day policosanol, or placebo.

Outcome Measure: Primary outcome measure was the percent change of LDL-C. Secondary outcome measures were changes in other lipoprotein fractions.

Results: A total of 143 patients were randomized at equal numbers to the five groups and were analyzed on an intention-to-treat basis. In none of the five treatment groups did LDL-C decrease more than 10 percent from baseline. There was no statistically significant difference between any active treatment group (policosanol) and placebo. A non-parametric test analyzing dose-dependency yielded non significant results. In none of the secondary outcome measures, namely total cholesterol, HDL-C, VLDL-C, triglycerides, ratio of total or LDL-C to HDL-C, and lipoprotein(a), were there any significant effects of policosanol. Policosanol was tolerated well without severe adverse events.

Conclusions: Sugar cane-derived policosanol has no lipoprotein-lowering effects in white patients with hypercholesterolemia or combined hyperlipidemia beyond placebo.

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