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Merck fails to win FDA panel backing for Vytorin heart claim

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012.

Merck & Co should not be allowed to claim that its cholesterol-lowering drug Vytorin reduces the risk of heart attacks and strokes in patients with coronary heart disease, an advisory committee to the U.S. Food and Drug Administration concluded on Monday.

The panel evaluated data from an 18,000-patient trial known as Improve-It whose results showed that the combination treatment known as Vytorin, comprising Zetia and an older cholesterol-lowering drug, simvastatin, reduced the rates of heart attack, stroke and death compared with simvastatin alone.

But the panelists voted 10-5 against allowing Merck to make the claim, saying they were not convinced the benefit was clinically meaningful, especially since...


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