Policosanol and Lipid Levels - Policosanol and Lipid Levels

Description:

The goal of the trial was to evaluate the effect of policosanol, a natural supplement derived from sugar cane, compared with placebo on lipid levels among patients with hypercholesterolemia or combined hyperlipidemia.

Study Design

Study Design:

Patients Screened: 216
Patients Enrolled: 143
Mean Follow Up: 12 weeks
Mean Patient Age: Mean age 56 years
Female: 61

Patient Populations:

Known or newly detected isolated hypercholesterolemia or combined hyperlipidemia, defined as baseline LDL-C ≥150 mg/dL and either ≤1 cardiovascular risk factor other than known coronary heart disease (CHD), or baseline LDL-C of 150-189 mg/dL for patients with ≥2 risk factors.

Exclusions:

Myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting <1 year before trial inclusion, unstable angina pectoris, uncorrected hypothyroidism, diabetes, other endocrine or metabolic diseases, acute inflammatory diseases, severe gastrointestinal diseases, triglyceride levels >500 mg/dL at visits 2 or 3, use of systemic corticosteroids, anticoagulants, or lipid-lowering drugs, treatment within the previous 6 weeks with any medication that is known to affect lipoprotein levels, severe kidney or liver disease, or other severe diseases.

Primary Endpoints:

Dose-dependence of LDL-C levels for policosanol compared with placebo.

Secondary Endpoints:

Dose-dependence of total cholesterol, very low-density lipoprotein cholesterol (VLDL-C), lipoprotein(a), and triglyceride levels for policosanol compared with placebo; change in ratios of total or LDL-C to high-density lipoprotein cholesterol (HDL-C), and change in HDL-C.

Drug/Procedures Used:

Following a 6 week run-in period, patients were randomized in a double blind manner to 12 weeks of treatment with placebo (n=29) or one of four doses of policosanol (n=114); doses 10, 20, 40, or 80 mg/d). Fasting lipid profiles were conducted through 12 weeks.

Principal Findings:

Mean baseline LDL level was 187 mg/dl, HDL was 51 mg/dl, total cholesterol 282 mg/dl and triglyceride 175 mg/dl.

There was no significant dose dependence in LDL reduction from baseline to 12 weeks with placebo compared with the 4 policosanol dose groups (mean change -8.1% for placebo, -5.2% for 10 mg, -5.1% for 20 mg, -2.0% for 40 mg, and -8.3% for 80 mg; p=0.30 for dose-dependence). Likewise, there was no difference in other lipid parameters for placebo vs policosanol, including 12 week HDL (49 mg/dl for placebo, 53 mg/dl for 10 mg, 56 mg/dl for 20 mg, 52 md/dl for 40 mg, and 54 mg/dl for 80 mg) and total cholesterol (257, 276, 271, 270, and 274 mg/dl, respectively). There was no difference in adverse events between placebo and the policosanol groups (at least one adverse event: 28% with placebo, 21% with 10 mg, 37% with 20 mg, 37% with 40 mg, and 34% with 80 mg).

Interpretation:

Among patients with hypercholesterolemia or combined hyperlipidemia, treatment with policosanol, a natural supplement derived from sugar cane, was not associated with differences in change in LDL at 12 weeks compared with placebo.

Several prior small studies, most of which were conducted in Cuba by a single group, have suggested that policosanol lowers LDL to a similar degree as statin therapy. However, another trial conducted in the Netherlands did not show a reduction in LDL with policosanol. The present findings are similar to the latter trial, with no benefit evident with policosanol. It should be noted that all patients in the present study reported to be white race, and it is unknown if the effect of policosanol on LDL differs by ethnicity given the results of the Cuban studies. However, the magnitude of differences in LDL reduction between the trials suggests this would not be the main explanation of the lack of benefit.

References:

Berthold HK, et al. Effect of Policosanol on Lipid Levels Among Patients With Hypercholesterolemia or Combined Hyperlipidemia. JAMA. 2006;295:2262-2269.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Homozygous Familial Hypercholesterolemia, Lipid Metabolism, Nonstatins, Novel Agents, Statins, Diet

Keywords: Fatty Alcohols, Cholesterol, Hyperlipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Coronary Disease, Risk Factors, Hypercholesterolemia, Triglycerides, Fasting


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