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FDA approves Zetia for new use

The FDA has approved Merck & Co and Schering-Plough's Zetia for use in combination with fenofibrate for the reduction of elevated total cholesterol and LDL "bad" cholesterol in patients with mixed hyperlipidemia, when diet alone is not enough.

Zetia is the first in a class of cholesterol-lowering agents that inhibits the intestinal absorption of cholesterol through a unique mechanism of action. With this new indication, Zetia offers patients with mixed hyperlipidemia another treatment option when it is prescribed in combination with fenofibrate.

Fenofibrate is commonly used along with diet to treat hyperlipidemia and has proven efficacy in lowering triglyceride levels and increasing HDL “good” cholesterol.

Mixed hyperlipidemia is a metabolic disorder characterized by elevated LDL cholesterol, elevated triglycerides (a form of fat in the bloodstream), and reduced levels of HDL cholesterol.

“This is an exciting new development in the treatment of mixed hyperlipidemia. Zetia and fenofibrate taken together offer complementary lowering of LDL and total cholesterol in patients with mixed hyperlipidemia,” said Dr Harold Bays, medical director, president of L-MARC Research Center, Louisville.