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ACC speaks out in favor of waiting for results of further Vytorin trials

1/27/2008

WASHINGTON With all the fallout from the ENHANCE trial regarding Merck and Schering-Plough’s cholesterol drug Vytorin, there is one positive show of support for the drug and it comes from the American College of Cardiology, according to published reports.

The ACC issued a statement saying that “major clinical decisions [should] not be made on the basis of the ENHANCE study alone [as it deserves] serious thought and follow-up.” The overall incidence rates of cardiac events were nearly identical between both treatment groups and both were generally well tolerated, the statement said, so “there should be no reason for patients to panic.” It added that the ENHANCE trial “is an imaging study and not a clinical-outcome study,” and that conclusions should not be made until three large clinical-outcome trials are presented within the next two to three years.

But, there are still many who feel the drug is unsafe and has been since it was put on the market. Sidney Wolfe, director of Health Research Group at Public Citizen, said that “we first warned against using Vytorin in December 2004” and suggested people should wait at least seven years before taking the treatment as it was not a “breakthrough” drug.

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