Policosanol for the Treatment of Hypercholesterolemia

Hyperlipidemia Clinical Trial

Official title: Policosanol for the Treatment of Hypercholesterolemia

Status Completed

Clinical Trial Summary

Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba.

This study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.

The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH).

Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.

Clinical Trial Description

Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Policosanol has been used in Cuba since 1991 to treat high cholesterol. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba. According to the Cuban data, policosanol can lower total cholesterol, lower low-density lipoprotein cholesterol (LDL-C), and raise high-density lipoprotein cholesterol (HDL-C). Based on post-marketing surveys, this drug appears to be devoid of any biochemical, hematological, or clinical adverse effects.

Confirmation of this data on policosanol by scientifically rigorous experiments and trials in this country would provide a safe and effective therapeutic option for the treatment of hypercholesterolemia. Consequently, policosanol has the potential to become a valuable tool in the fight against coronary heart disease - a major cause of mortality in the United States.

This pilot study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.

The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH). Future studies could include an assessment of the effects of policosanol on other markers for coronary heart disease and potential use in combination with current lipid medications. The overall goal is to perform a large multi-center clinical outcome trial to establish the precise clinical benefits of policosanol.

Summary: Demonstration of the lipid-lowering ability of policosanol is an initial step in providing a safe, cost-effective therapy for hypercholesterolemia, thereby advancing the treatment and prevention of cardiovascular disease in this country.

Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.

Hypotheses: After 8 weeks of therapy policosanol 40 mg/day will:

1. Produce a statistically significant reduction in LDL-C compared to placebo.

2. Provide a statistically significant reduction in LDL particle number and C-reactive protein. ;

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

• NCT number: NCT00255216
• Study type: Interventional
• Source: Wake Forest University Health Sciences
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Completion date: August 2005