April 01, 2008

Vytorin Study Raises Questions

This raises more questions than it answers.

The news keeps getting worse for two heavily promoted cholesterol drugs, Vytorin and Zetia. These drugs were supposed to offer a valuable alternative to the older cholesterol-lowering agents known as statins, a class that includes Lipitor, Zocor and other drugs that not only reduce cholesterol but also reduce the risk of heart attacks. In clinical trial results released this week, the newer drugs failed to reach their main goal: slowing the growth of artery-clogging plaques — a suggestion that they might not help ward off heart attacks.

* * *

In the clinical trial, 720 European patients with genes that cause abnormally high cholesterol levels were given either Vytorin, a combination pill that contains both Zetia and Zocor, or simply Zocor alone. As expected, the combination pill proved better than the statin alone at reducing the level of bad cholesterol. But to everyoneÂ’s surprise, Vytorin failed to slow the growth of fatty plaques in the arteries, and it may have even allowed greater growth than the statin did.

It seems clear that there is an issue with Zocor. But is Zetia as flawed a drug? I asked one doctor that question yesterday, only to be told that her reading of the study is that the problem is with Zocor itself, because of the lack of a sample with Zetia being given alone. And given that the drug is effective with its primary purpose, Zetia remains a good drug for those who have difficulties with the statin drugs.

I suspect we will hear more in the not terribly distant future about other studies. But one would have hoped that this would have been vetted during the approval process.

Posted by: Greg at 10:09 PM | Comments (59) | Add Comment
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