Will a new indication reverse Vytorin's downward spiral? We may well get an opportunity to find out. In trial data presented over the weekend, the cholesterol drug beat placebo at preventing cardiovascular trouble in kidney patients. Sixteen percent fewer heart events for Vytorin patients compared with placebo patients, to be exact.
So now, Merck ($MRK) plans to ask the FDA for approval to market Vytorin for patients with chronic kidney disease. Currently approved to treat high cholesterol, the drug combines a statin (simvastatin) with Zetia (ezetemibe), which lowers cholesterol by a different mechanism. The drug was once a major seller for Merck, but began to lose patients after the Enhance trial showed it didn't treat artery-hardening any better than simvastatin alone. And since then, some trial data hinted that Zetia might be linked with an increased cancer risk.
A positive trial in a new area is a big deal for Vytorin--and that the 9,000-patient study showed no increase in cancer risk helps, too. But there's some skepticism that the combo drug would perform any better than its statin ingredient alone, or compared with another statin drug, for that matter. Statins haven't been studied specifically for kidney patients before.
That question could be answered by another trial that compares Vytorin specifically with simvastatin. But that study won't be finished until 2013. And there's another caveat, as the New York Times points out: Vytorin's heart benefits in the new study were largely in preventing artery-clearing procedures and certain types of strokes--not heart attacks or deaths. Still, that Vytorin did succeed in this trial is good for Merck.