Study finds colesevelam effective in reducing LDL cholesterol

October 22, 2001

ROCHESTER, MINN. -- Colesevelam hydrochloride appears to be an effective lipid-lowering agent that significantly reduces low-density lipoprotein (LDL) cholesterol levels, according to a study published in the October issue of Mayo Clinic Proceedings.

The researchers involved in the double-blind, placebo-controlled trial concluded that colesevelam was efficacious, decreasing mean LDL levels by up to 18 percent, and was well-tolerated without serious adverse events. Elevated LDL cholesterol is a major risk factor contributing to the development and progression of atherosclerotic disease and coronary heart disease. Atherosclerotic coronary heart disease is a major cause of death and disability, affecting approximately 14 million adults in the United States.

"Past clinical studies have shown that cholesterol-lowering therapy is effective in reducing the risk of coronary heart disease as well as decreasing coronary events in patients with established coronary heart disease," says Michael H. Davidson, M.D., senior author of the study. "Colesevelam appears to be a useful therapeutic alternative for patients with mild to moderate primary hypercholesterolemia."

Hypercholesterolemia occurs when abnormally high concentrations of cholesterol are present in the bloodstream. It can lead to heart disease, hardening of the arteries, heart attack and strokes.

Colesevelam was administered for treatment of mild to moderate hypercholesterolemia in a randomized, double-blind, placebo-controlled multicenter trial in 1998. The 18-center study had 494 patients during the 24-week treatment period. Colesevelam lowered mean LDL levels from nine percent to 18 percent. Mean total cholesterol levels decreased four percent to 10 percent.

The researchers note that the degree of lipid lowering with colesevelam was independent of sex or age. Furthermore, colesevelam treatment was not accompanied by serious adverse events relative to placebo.
-end-
Joining Dr. Davidson of the Chicago Center for Clinical Research in authoring this study were: William Insull Jr., M.D., of the Baylor College of Medicine, Lipid Research Clinic; Phillip Toth, M.D., Midwest Institute for Clinical Research, Inc., Indianapolis, Ind.; William Mullican, M.D., MediSphere Medical Research Center, LLC, Evansville, Ind.; Donald Hunninghake, M.D., University of Minnesota, Heart Disease Prevention Clinic; Steven Burke, M.D., and Joanne M. Donovan, M.D., Ph.D., both of GelTex Pharmaceuticals, Inc., Waltham, Mass.

The study was funded by GelTex Pharmaceuticals, Inc., Waltham, Mass., the developer of colesevelam. Drs. Hunninghake and Davidson have served as consultants to GelTex Pharmaceuticals, Inc.

Mayo Clinic Proceedings is a peer-reviewed and indexed general internal medicine journal, published for 75 years by Mayo Foundation, with a circulation of 130,000 nationally and internationally.

To obtain news releases from Mayo Clinic, go to www.mayo.edu/news. MayoClinic.com (www.mayoclinic.com) is available as a resource for your health stories (note name change from Mayo Clinic Health Oasis/mayohealth.org).

Oct. 22, 2001
John Murphy
507-284-5005 (days)
507-284-2511 (evenings)
e-mail: newsbureau@mayo.edu

Mayo Clinic

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