Vytorin Fails to Lower Heart Valve Problems

Latest multi-country study shows troubled cholesterol drug no better than placebo at easing cardiovascular events in targeted patients

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MONDAY, July 21 , 2008 (HealthDay News) -- The controversial cholesterol drug Vytorin does not lower the risk of major heart valve problems, according to a report released Monday by its manufacturers, Schering-Plough Corp. and Merck & Co.

In a multi-country study of 1,873 patients, the drug was no better than placebo at lowering the odds of major cardiovascular events in patients suffering from aortic stenosis, a condition involving blocked blood flow to the heart.

Vytorin also failed to meet its secondary goal of improving aortic valve disease events, which included surgeries for valve replacement, hospitalization because of heart failure, and death related to cardiac causes, the Associated Press reported.

The drug did meet a secondary goal of reducing atherosclerotic disease in the trial, called SEAS. But it also appeared to involve a higher number of cancer deaths, although the study authors said the numbers were small and could be a result of chance, AP reported.

Vytorin is a prescription pill containing two cholesterol-lowering medications, Zetia (ezetimibe) plus Zocor (simvastatin) .

In January, the manufacturers released results of a two-year trial of 720 patients, which experts said shed doubt on whether people battling cholesterol should take Vytorin versus Zocor alone.

That trial, called Enhance, showed that the pace at which artery-clogging plaques formed within vessels almost doubled in patients taking Vytorin, compared to those taking Zocor alone, the trial found.

"This wraps it up," said Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic, at the time the initial results were announced. "That's all there is. There just isn't any evidence that adding ezetimibe to simvastatin produces any advantage."

No one disputes that Zetia can lower levels of LDL "bad" cholesterol by 15 percent to 20 percent -- that had been shown in previous trials. However, whether that reduction led to any greater lowering of heart attack or stroke risk had remained unclear.

"These results are very important considerations on how we treat patients with elevated cholesterol and will very likely impact the way we choose drugs to lower cholesterol and eliminate plaque," Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardio-Vascular Disease at New York University Medical Center, said at the time.

After the Enhance results were released in January, officials at the U.S. Food and Drug Administration said they would review the medication's effectiveness, but only after they get a final report, which was not due for several months.

And since January, according to news reports, sales of the once-blockbuster drug have slumped.

More information

There's more on lowering cholesterol at the American Heart Association.

SOURCES: Steven Nissen, M.D., chairman, department of cardiology, Cleveland Clinic; Howard Weintraub, M.D., clinical director, Center for the Prevention of Cardio-Vascular Disease, New York University Medical Center, and clinical associate professor, NYU School of Medicine, New York City; Associated Press

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