Effect of policosanol on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia: a randomized controlled trial.
BACKGROUND
Policosanol is a natural substance derived from sugar cane that is advertised for its lipid-lowering effects as a nonprescription drug. More than 80 placebo-controlled or comparative trials, performed mostly by a single research institute, suggest that policosanol at doses of 5 to 40 mg/d has lipoprotein-lowering effects comparable with statins.


OBJECTIVE
To determine the lipoprotein-lowering effects of Cuban sugar cane-derived policosanol and to establish, if effective, dose-dependency up to 80 mg/d in patients with hypercholesterolemia or combined hyperlipidemia.


METHODS
A multicenter (lipid outpatient clinics and general practitioners in Germany), randomized, double-blind, placebo-controlled, parallel-group trial conducted from September 29, 2000, to May 10, 2001, of patients with hypercholesterolemia or combined hyperlipidemia having baseline low-density lipoprotein cholesterol (LDL-C) levels of at least 150 mg/dL (> or =3.88 mmol/L) and either no or 1 cardiovascular risk factor other than known coronary heart disease, or baseline LDL-C levels of between 150 and 189 mg/dL (3.88-4.89 mmol/L) and 2 or more risk factors.


METHODS
Open-label 6-week placebo and diet run-in phase followed by a double-blind 12-week treatment phase after randomization to 5 groups: 10, 20, 40, or 80 mg/d of policosanol or placebo.


METHODS
The percentage change of LDL-C, with changes in other lipoproteins as secondary outcome measures.


RESULTS
A total of 143 patients were randomized to 5 equal groups and were analyzed on an intention-to-treat basis. In none of the 5 treatment groups did LDL-C levels decrease more than 10% from baseline. No statistically significant difference between policosanol and placebo was observed. A nonparametric test analyzing dose-dependency yielded nonsignificant results. In none of the secondary outcome measures, namely total cholesterol, high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol, triglycerides, lipoprotein(a), and ratio of total or LDL-C to HDL-C, were there any significant effects of policosanol. Policosanol was tolerated well without serious adverse events.


CONCLUSIONS
In patients with hypercholesterolemia or combined hyperlipidemia, the sugar cane-derived policosanol in usual and high doses does not demonstrate a reduction in lipid levels beyond placebo.


BACKGROUND
clinicaltrials.gov Identifier: NCT00288483.
Berthold
Heiner K
HK
Department of Clinical Pharmacology, Institute for Clinical Research, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany. berthold@uni-bonn.de
Unverdorben
Susanne
S
Degenhardt
Ralf
R
Bulitta
Michael
M
Gouni-Berthold
Ioanna
I
D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005233:Fatty Alcohols / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D006949:Hyperlipidemias / Q000097:blood / Q000188:drug therapy*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged
D000924:Anticholesteremic Agents; D005233:Fatty Alcohols; D008055:Lipids; C080710:policosanol