Daiichi Sankyo: WelChol added to statin therapy reduces median hs-CRP levels

By Lisa Kerner

Erie, Pa., April 18 - Daiichi Sankyo, Inc. said data published in the April 15 issue of the American Journal of Cardiology demonstrated that adding WelChol (colesevelam hydrochloride) to stable statin therapy (i.e. Zocor (simvastatin), Lipitor (atorvastatin calcium) or Pravachol (pravastatin sodium)) further reduced mean LDL-C, or "bad" cholesterol, and median high-sensitivity C-reactive protein (hs-CRP) levels.

This is the first data to demonstrate that WelChol, a bile acid sequestrant, when added to statin therapy, reduces hs-CRP levels. Hs-CRP, a marker of arterial inflammation, is also a strong predictor of coronary heart disease events, according to a company news release.

The addition of a placebo to statin therapy led to a median hs-CRP increase of 17.2%, while the addition of WelChol to statin therapy led to a median hs-CRP drop of 6.2%.

Daiichi Sankyo said pooled study results also demonstrated that WelChol plus a statin, compared to a placebo, lowered mean LDL-C, a risk factor for coronary heart disease, and reduced mean total cholesterol.

Unlike other cholesterol-lowering drugs, WelChol is not absorbed by the body and is eliminated without traveling to the liver or kidneys.

"Bile acid sequestrants were one of the first approved cholesterol-lowering drugs, having been studied in the 1970s, before hs-CRP was routinely measured," said Harold E. Bays, lead study investigator with the Louisville Metabolic and Atherosclerosis Research Center Inc., in the release.

"This analysis finally brings the past to the present, in that it is the first to show that a non-systemic agent, specifically WelChol, when added to a statin, statistically reduces hs-CRP, an important marker of arterial inflammation."

Data were obtained from three randomized double-blind placebo-controlled parallel multicenter trials of 204 patients conducted in the United States between November 2002 and July 2003.

Daiichi Sankyo, Inc., the U.S. subsidiary of Japanese pharmaceutical company Daiichi Sankyo Co., Ltd., focuses on cardiovascular disease, glucose metabolic disorders, infectious diseases, cancer, immunology and bone and joint diseases. The company is based in Parsippany, N.J.

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