Popular Anti-Cholesterol Drug Vytorin Misses Another Significant Study Endpoint

Early news from another trial involving former blockbuster drug Vytorin will not be good for investors and its parent Pharma company.

The combination was significantly more effective than placebo in reducing the risk of ischemic events, a secondary composite end point of nonfatal MI, coronary artery bypass graft (CABG) surgery, PCI, hospitalization for unstable angina, nonhemorrhagic stroke, and cardiovascular death. Vytorin failed to meet a secondary goal of improving aortic-valve disease events, which included valve-replacement surgery, hospitalization because of heart failure, and cardiovascular mortality.

“The SEAS study has given a clear-cut answer to the question of whether intensive lipid lowering will influence the course of aortic-stenosis disease. I think we can conclude that it does not,” announced Dr Terje Pedersen (Ulleval University Hospital, Oslo, Norway), chair of the steering committee, during a conference call today with the media. “We have also shown there is benefit in treating such patients with the study drug combination, as we saw a reduction in the risk of coronary artery disease.”

You may recall that Vytorin encountered hot water (and its market share took a big hit) when a previous scientific trial showed no difference between this combination drug and simvastatin (one of Vytorin’s component agents) alone in the treatment of coronary artery disease and prevention of its adverse outcomes. | LINK | Previous Doctor Pundit coverage here.