Merck, Schering's Vytorin fails trial

The gig is up, the news is out. Merck and Schering-Plough announced the results of its big ENHANCE trial this morning. And, as observers had begun to suspect, the study showed that, when it comes to arterial thickness, there was no significant difference between treatment with generic simvastatin (Zocor) and Vytorin, which combines Zocor and Zetia (ezetimibe).

The study did show a big advantage in cholesterol-lowering with the combo treatment, Vytorin. Patients saw their "bad" cholesterol drop by 58 percent with Vytorin versus 41 percent with Zocor alone. But other studies haven't shown a difference in patient outcomes, such as fewer heart attacks or strokes.

As you know, Merck and Schering embarked on this study hoping that Vytorin could trounce Zocor, and therefore elbow aside not only Zocor's generic competitors but other statins, too. But after the data came in, the companies delayed its release, and even made a feint toward changing the trial's primary endpoint [1]. Critics denounced that idea, and the streets were buzzing with speculation about the trial results. (It didn't help that the companies were accused of withholding damaging data from other Vytorin studies.) Apparently, Merck and Schering decided that the truth, while none too impressive, was better than the speculation.

- see the release [2] from Merck
- read a brief story [3] from Dow Jones
- read some cardiologists' speculation [4] in the Wall Street Journal Health Blog

Related Articles:
Merck, Schering left trial chief out. Report [1]
Schering CEO defends Vytorin decisions. Report [5]
Merck, Schering backpedal on Vytorin. Report [6]