The Vytorin outcomes trial will go on. That's all the information we're getting out of the enormous Improve-It study for now. An independent data monitoring board looked at the trial's results so far and recommended that it continue.
No hint about interim results. Nothing but a green light to go ahead. And so, analysts who'd been hoping for an early Vytorin victory will have to wait for the final verdict. Improve-It is now expected to wrap up in September 2014.
It's no wonder that analysts are impatient; the market has wanted a verdict on Vytorin for years, ever since the controversial Enhance trial. That study compared Vytorin--which combines Merck's ($MRK) Zetia and the statin drug Zocor--with Zocor alone. The trial results were repeatedly delayed, and in the end, Vytorin failed to best the statin drug at beating atherosclerosis.
The trial's delays and Vytorin's failure caused a hue and cry. Politicians raised questions about the trial. Cardiologists debated Vytorin's usefulness. The drug's sales dwindled. And shareholders sued, claiming securities fraud; Merck settled those class actions last month for $688 million.
Merck is, of course, hoping for better results from Improve-It, which also pits Vytorin against Zocor. Improve-It is testing whether Vytorin cuts the risk of heart attack, stroke, cardiovascular death and the like when compared with statin therapy alone. More than 18,000 patients are participating.
- see the release from Merck
- read the Dow Jones story