Day three of chatter about Vytorin's poor performance in the ENHANCE study, and the furor seems to be increasing. On one side: The notorious Dr. Steve Nissen--and various other experts and doctors--who say Vytorin either shouldn't be used at all, or might be useful after other statins have failed. On the other: The American College of Cardiology.
The elite group of heart specialists says that "major clinical decisions" shouldn't be made based on the new study data. "Conclusions should not be made until the three large clinical outcome trials are presented within the next two or three years," the ACC said in a statement. "Zetia remain[s] a reasonable option" for certain patients, the group added. Wall Street analysts called the ACC statement "a major win for Schering-Plough and Merck."
Meanwhile, other experts say that the outcomes studies aren't likely to show much advantage for Vytorin. And amid questions about why Vytorin ever got approved in the first place, the FDA says it's evaluating the data, including--Time magazine says--ads that claim the drug could overcome high cholesterol whether caused by diet or genetics. The New York Times weighed in with an editorial saying that unless and until the outcomes studies show big benefit for Vytorin, the drug "should be used sparingly." Stay tuned for more expert and quasi-expert judgment. We're sure plenty of it will continue to fly.
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