Cholestin study showing "significant" cholesterol reduction presented by UCLA's Heber.

CHOLESTIN STUDY SHOWING "SIGNIFICANT" CHOLESTEROL REDUCTION was presented by the study's principal investigator, David Heber, MD/PhD, director of the UCLA Center for Human Nutrition, at the Federation of American Societies for Experimental Biology annual conference in San Francisco April 19. The double-blind, placebo-controlled, randomized study involved 83 subjects. Results have been accepted for publication in the American Journal of Clinical Nutrition.

Heber's trial is the first U.S. study to be completed on Cholestin, a Chinese red yeast rice product marketed by Simi Valley, Calif.-based Pharmanex as a dietary supplement. Other cholesterol-reduction data on Cholestin include 34 clinical trials from China, according to Pharmanex.

On average, total serum cholesterol decreased in the treated group from 254 +/- 36 to 208 +/- 31 mg/dL by eight weeks with no change in the control group, according to a summary of the study. Subjects were given 2.4 g of Cholestin or a placebo rice capsule daily. The study enrolled subjects who had "undesirably high" cholesterol levels but whose levels were not high enough to be considered diseased or candidates for drug therapy, the summary states.

At eight weeks, serum triglycerides declined from 133 +/- 48 to 118 +/- 41 mg/dL and LDL cholesterol decreased from 173 +/- 27 to 143 +/- 27 mg/dL. HDL cholesterol levels were unchanged. There were no significant differences in diets between the two groups as determined by food frequency questionnaires administered at the beginning of the study and at eight weeks, the summary states. All subjects were instructed to maintain a diet with less than 10% saturated fat and less than 300 mg cholesterol. The study found no adverse effects on liver or kidney function.

An open-label clinical study on Cholestin is under way in the U.S. in 165 subjects, with completion expected at the end of May, Pharmanex said. The study is being conducted by the company as a type of post-marketing surveillance effort in 11 clinical sites around the country. The trial began last summer.

So far, 118 subjects have completed the study and the data analyzed to date show a 13% average decline in cholesterol at four weeks and eight weeks compared to the beginning of the trial, Pharmanex said. Subjects, enrolled with cholesterol levels between 200-260 mg/dL, are given 2.4 g of Cholestin per day. The doctors administering the study are cardiologists and primary care physicians.

Pharmanex has been involved in an ongoing debate with FDA over the regulatory status of the cholesterol-reduction claims and the formulation of Cholestin. The agency said last fall it had preliminarily determined the product is an unapproved new drug. Cholestin contains lovastatin, the active ingredient in Merck's prescription cholesterol reducer, Mevacor. A final agency decision on Cholestin's regulatory status is pending.