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Merck’s Vytorin Cuts Heart Risk in Kidney Patients, FDA Says

November 01, 2011

(Updates with product sales in sixth paragraph.)

Oct. 28 (Bloomberg) -- Merck & Co.’s blockbuster cholesterol drug Vytorin reduces heart risks in patients with kidney disease, according to U.S. regulators weighing whether to approve the expanded use.

A clinical trial of the Whitehouse Station, New Jersey- based company’s drug showed it reduced the risk of “major vascular events” by 16 percent compared with a placebo, Food and Drug Administration staff said in a preliminary review posted today on the agency’s website. Outside advisers to the FDA are scheduled to meet Nov. 2 to evaluate the findings.

Merck reported last year that its 9,000-patient study was the first to show that lowering so-called bad cholesterol, or LDL, cuts heart-attack and stroke risks in people with chronic kidney disease. The renal disorder affects about 20 million adults in the U.S. and can lead to cardiovascular disease.

Statistical data support Merck’s claim that Vytorin reduces chronic kidney-disease patients’ cardiovascular risks, FDA staff said in the report. “However, the treatment effect appears to be heterogeneous among patients with different renal function status,” with most of the benefits occurring in patients who aren’t on dialysis.

Merck rose 2.3 percent to $35.11 at the close in New York. The shares have declined 2.6 percent this year.

Merck generated $2 billion in revenue last year from Vytorin, a combination of the cholesterol drugs Zetia and Zocor.

Zetia had 2010 sales of $2.3 billion, while Zocor earned $468 million. Zocor, or simvastatin, has been available in generic form since 2006.

Zetia works by limiting cholesterol absorption in the small intestine, while Zocor lowers cholesterol production by blocking an enzyme in the liver.

--Editors: Andrew Pollack, John Lear

To contact the reporter on this story: Molly Peterson in Washington at

To contact the editor responsible for this story: Adriel Bettelheim at

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