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FDA approves VYTORIN, first and only to powerfully reduce LDL cholesterol through dual inhibition

WHITEHOUSE STATION and KENILWORTH, N.J., July 23, 2004 Merck/Schering-Plough Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved VYTORINTM (ezetimibe/simvastatin) for the treatment of high LDL cholesterol (LDL-C) in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. VYTORIN is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food. The active ingredients in VYTORIN are ezetimibe and simvastatin. The recommended starting dose of VYTORIN is 10/20 mg (10 mg ezetimibe/20 mg simvastatin).

"Many patients who continue to have high cholesterol despite diet and other lifestyle modifications may require powerful LDL cholesterol-lowering agents and to do this we frequently look to highly efficacious medicines to provide the reduction they need," said Christie Ballantyne, M.D., director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, TX.

VYTORIN lowered LDL cholesterol by 52 percent at the recommended starting dose (10/20 mg) and 60 percent at the maximum dose (10/80 mg)

In a 12-week, multi-center, double-blind, placebo-controlled clinical study of 1,528 patients with LDL cholesterol levels of 145 mg/dL to 250 mg/dL, VYTORIN provided LDL cholesterol reductions of 52 percent at the recommended starting dose (10/20 mg), 55 percent at the 10/40 mg dose and 60 percent at the maximum dose (10/80 mg). VYTORIN is administered as a once-daily tablet and should be taken in the evening with or without food.

"VYTORIN is the first single cholesterol treatment to provide LDL cholesterol lowering through dual inhibition of cholesterol production and absorption. VYTORIN represents an important new treatment alte
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23-Jul-2004


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