Vytorin outcomes study barrels on without a peek
The Vytorin outcomes study is going ahead without a hint about how things are faring. The safety monitors of Improve-It, which is testing Merck's ($MRK) cholesterol-fighting drug Vytorin, say no new dangers have cropped up among the 18,000 patients enrolled. The pill combines a long-used Merck statin, Zocor (simvastatin), and its newer drug Zetia, which lowers cholesterol via a different mechanism.
What Merck didn't say is whether the Vytorin combo pill is actually any better than a garden-variety statin drug at battling heart disease. That information will have to wait. Although investors were hoping for an interim look at the study data, Merck says it's still blinded to the results, Reuters reports. The study isn't due to wrap up until June 2013.
What we do know is that adding Zetia to statin therapy does lower "bad" cholesterol more than the statin alone. And we also know that adding Zetia to the mix did not combat arterial thickening any better than Zocor did by itself (that info came from a previous study pitting Vytorin against its statin component). That's the study whose release was delayed for many months, touching off questions about the drugmakers' handling of the data; Merck and partner Schering-Plough raised their own questions about the imaging used in the study.
Since the previous study was released, Vytorin sales have slid. Prescriptions in the U.S. have dropped 70%, Forbes reports. Some good outcomes data could turn that around. But mediocre results could well hasten that slide. Vytorin's patent is scheduled to expire in 2017, while Zetia's exclusivity lapses next year.