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May 21, 2006

Cholesterol study is bitter pill for sugar cane derivative

Substance used in vitamins, dietary supplements failed to lower LDL levels, researchers say

By Lindsey Tanner

CHICAGO -- German research casts doubt on the effectiveness of a sugar cane-based ingredient sold as a cholesterol treatment in One-A-Day vitamins and other products marketed in dozens of countries.

The substance, called policosanol, worked no better than dummy pills in German adults with high levels of LDL cholesterol, the bad kind that can clog arteries and lead to heart problems.

Even in high doses, policosanol derived from Cuban sugar cane produced no meaningful changes in cholesterol levels during 12 weeks of treatment, said lead author Dr. Heiner Berthold of the German Medical Association's drug commission.
Most previous studies that reached the opposite conclusion were sponsored by a company founded by Cuba's National Center for Scientific Research to market policosanol, the German researchers said. The Cuban scientific center didn't respond to requests for comment.

The German study involving 143 people appeared in Wednesday's Journal of the American Medical Association.

Patients were randomly assigned to get policosanol in various doses or dummy pills for 12 weeks. There was no difference in the levels of LDL in volunteers in either group.

Berthold, executive secretary of the German Medical Association's drug commission, said his research doesn't rule out that policosanol might be effective in different ethnic groups or that other formulations might have different effects.

But he thinks the product's claims have been overstated because there's no "mechanism of action" to explain how it might lower cholesterol.
Policosanol is a combination of alcohols that come from plant wax. Cuban sugar cane-based policosanol is sold in more than 40 countries, mostly as a cholesterol treatment, the researchers said. Other sources for the ingredient include wheat germ, rice, bran and beeswax. Policosanol products are widely available on the Internet and in stores.

Bayer Consumer Care uses sugar cane-based policosanol in its One-A-Day Cholesterol Plus vitamins and calls it "the leading complete multivitamin specially formulated with heart-supporting nutrients."

Bayer spokeswoman Tricia McKernan said the study "was not designed to address a claim that along with diet and exercise, policosanol can help maintain healthy cholesterol levels already within the normal range."

"Bayer makes only the latter claim and agrees with the authors that consumers should always discuss their cardiovascular risk profile with their doctor," McKernan said.

Andrew Shao, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, a trade group for dietary supplement makers, said the new research "is only one study" and not the final word on policosanol.

JAMA, Press Release, May 16, 2006

STUDY INDICATES WIDELY-USED NUTRITIONAL SUPPLEMENT DOES NOT IMPROVE CHOLESTEROL LEVELS

CHICAGO-A new study suggests that use of the nutritional supplement policosanol does not lower cholesterol levels any more than placebo, apparently contradicting the results of previous studies, according to a study in the May 17 issue of JAMA.

Policosanol is a natural substance produced from the waxy coating of sugar cane. Cuban sugar cane policosanol is sold in more than 40 countries mainly because of its supposed lipid-lowering effects, according to background information in the article. Numerous policosanol products from a variety of sources (sugar cane, wheat germ, rice bran, beeswax) are available over-the-counter and on the Internet in several countries. Advertising emphasizes predominantly its reputed lipid-lowering effects, comparable with statins (prescription medications taken to lower cholesterol). Most of the published scientific literature, more than 80 trials, supporting the beneficial effects of policosanol on lipids has been authored by a single research group from Cuba. One clinical trial from the Netherlands showed wheat germ-derived policosanol ineffective in lowering total cholesterol and low-density lipoprotein cholesterol (LDL-C), sometimes called "bad" cholesterol.

Heiner K. Berthold, M.D., Ph.D., of the University of Cologne, Germany, and colleagues conducted a study to determine the lipid-lowering effects of policosanol. The multicenter, randomized, double-blind, placebo-controlled, trial included 143 patients with hypercholesterolemia (high cholesterol) or combined hyperlipidemia (excess of fats or lipids in the blood) having baseline LDL-C levels of at least 150 mg/dL 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 and 2 or more risk factors. The patients were randomized into 5 groups: 10, 20, 40, or 80 mg/d of policosanol or placebo. The study was conducted from September 2000 to May 2001.

In none of the 5 treatment groups did LDL-C levels decrease more than 10 percent from baseline. No statistically significant difference between policosanol and placebo was observed. In none of the secondary outcome measures, namely total cholesterol, high-density lipoprotein cholesterol (HDL-C; known as "good" cholesterol), very low-density lipoprotein cholesterol, triglycerides, lipoprotein(a) (a family of lipoprotein particles varying in density and size), and ratio of total or LDL-C to HDL-C, were there any significant effects of policosanol. Policosanol was tolerated well and no severe adverse events occurred.

"Our results suggest that policosanol is devoid of clinically relevant lipoprotein-lowering properties in white patients. Still, more independent studies are required to counterbalance the vast body of available positive trials. Although policosanol has been used for more than a decade in clinical trials, there are still no data on patient-related outcomes, such as cardiovascular morbidity and mortality. Moreover, independent information should be given to consumers who might take policosanol to improve their cardiovascular risk profile," the authors conclude.

(JAMA. 2006;295:2262-2269. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was sponsored by Madaus AG, Cologne, Germany, which also provided funding of the contract research organization involved. Neither Madaus AG nor any of their subsidiary companies manufacturers or distributes any lipid-lowering drugs, including statins.
Media Advisory: To contact Heiner K. Berthold, M.D., Ph.D., email: berthold@uni-bonn.de