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No Proof Combo Pills Like Vytorin Work Better, Study Finds

Sep 3, 2009 | Parker Waichman LLP

A new study says there is no proof that combo cholesterol lowering drugs like Vytorin work better than high doses of statins.   

Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor.   Vytorin was approved by the Food & Drug Administration in 2004 to treat both sources of cholesterol - absorption in the intestine of both biliary and dietary cholesterol, and production in the liver and peripheral tissues. It was believed that the treatment of cholesterol from both sources would likely to result in lower cholesterol levels. It was likewise theorized that this reduction in cholesterol would in turn reduce the amount of plaque buildup in the arteries, thus reducing the risk of heart attack and stroke.

According to Bloomberg News, in an analysis of 102 studies, researchers found no proof that  combo pills like Vytorin extended life expectancy more than taking a high dose of a single statin, like Lipitor. The study  was released today by the Annals of Internal Medicine.

The researchers said that few of those studies included in the analysis were long enough to be able to detect a benefit.  The study's lead author told Bloomberg News that drugmakers should do larger, long-term studies of combination pills to prove their worth.

Vytorin's supposed benefits have been the subject of controversy since the ENHANCE study was released in January 2008. ENHANCE found that the drug was no better than a cheaper, generic statin in preventing clogged arteries, and raised serious questions about the effectiveness of both Vytorin and Zetia. What’s more, Merck and Schering-Plough delayed releasing ENHANCE for more than a year, even though the trial was actually completed in 2006.

The ENHANCE controversy spawned scores of lawsuits against Merck and Schering-Plough. Many accused the companies of marketing Vytorin and Zetia in a misleading fashion and failing to disclose the results of ENHANCE in a timely manner.  Last month, Merck and Schering-Plough agreed to pay $41.5 million to settle class-action lawsuits stemming from that debacle.

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