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FDA Will Wait for Trial Results on Vytorin
Date:1/25/2008

ce in risk of heart attack or stroke between the two treatments.

Jenkins said another ongoing trial will evaluate the effect of Vytorin compared with Zocor on heart disease and stroke. Results from this trial will be available in 2011, he said.

Merck/Schering-Plough Pharmaceuticals, the makers of Zetia and Vytorin, have been criticized for not releasing the Enhance test results earlier.

"While the Enhance trial was time-consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial," Thomas Koestler, president of the Schering-Plough Research Institute, said in a prepared statement released Friday.

Dr. Harlan M. Krumholz, a professor of medicine at Yale University School of Medicine, said the FDA is right to wait until all the results from the Enhance trial are in. But in the meantime, he said, Vytorin and Zetia should be limited to patients who can't tolerate cholesterol-lowering drugs called statins, such as Lipitor.

"We have enough information from Enhance to say it is not providing much evidence that this drug is delaying the progression of atherosclerosis," he said. "It raises uncertainty whether this drug produces benefits for actual patients."

"This [Vytorin] is really a second-line drug," Krumholz said. "We really should be guided by evidence, not marketing, and the evidence is really strong for statins. If lifestyles aren't sufficient to lower cholesterol, the next place they should go is statins. Only after those have failed should you go to the next step," he added, referring to Vytorin.

More information

For more information on lowering cholesterol, visit the American Heart Association.



SOURCES: Harlan M. Krumholz, M.D., professor, medicine, Yale University Schoo
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