Study questions Vytorin and Zetia in heart disease treatment - washingtonpost.com

Study questions Vytorin and Zetia in heart disease treatment - washingtonpost.com

A widely prescribed and expensive cholesterol drug does not unclog arteries as effectively as a modified version of Vitamin B3, a cheap alternative used to treat heart disease for decades, according to a new study.

The research, which appears Monday in the New England Journal of Medicine, is sending rumbles through the medical community because it is the third recent study to raise questions about the effectiveness of Zetia and its sister drug, Vytorin, highly profitable pharmaceuticals made by Merck & Co.

"This is the third strike," said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic in Ohio. "The studies are telling us that it doesn't appear to produce benefits. This is a drug used by millions of Americans, a very big seller, in a health-care system where costs are a major issue. And the question has to be, is this the right approach?"

Vytorin and Zetia are among the most popular of prescription drugs. Last year, physicians in the United States wrote more than 29 million prescriptions for both drugs combined, and worldwide sales totaled $4.56 billion, according to Merck.

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Introduced in 2002 and 2004 amid heavy direct-to-consumer marketing, Zetia and Vytorin became blockbusters for Merck and Schering-Plough, which had collaborated on their development. The companies recently merged.
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Taken as a whole, the new research is unnerving, said Harlan Krumholz, a Yale University cardiologist. "The accumulating evidence isn't giving you any confidence," he said. "This is a very expensive drug being used without any strong evidence that it's benefiting patients . . ." Zetia and Vytorin should be "drugs of last resort, if used at all," Krumholz said. "And anyone who uses it should make sure patients are informed that they're taking a gamble."
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The patients who took Niaspan (Vitamin B3 Niacin) had less plaque in their arteries and also had higher levels of high-density lipoprotein or HDL. Known as "good" cholesterol, HDL is believed to remove cholesterol from the arteries and carry it back to the liver, where it is passes from the body.

The patients who took Zetia had more plaque in their arteries but lower levels of LDL. They also had more heart attacks, strokes and other cardiovascular problems than the patients taking niacin. Merck President Peter Kim said the fact that Zetia lowers LDL cholesterol makes it valuable. "It's very well established that lowering LDL saves lives," he said.

Roger S. Blumenthal, a cardiologist at Johns Hopkins, criticized the new study in an editorial also published Monday in the New England Journal of Medicine. Blumenthal, who has been a paid speaker for Merck, noted that the new study was halted early, which meant results from 40 percent of the participants were not included in the final analysis. ...