PharmExec Blog

FDA Declares: Keep Taking Your Vytorin

It’s official. Vytorin (ezetimibe/simvastatin) still does what it’s supposed to do—significantly decrease LDL cholesterol.

FDA, yesterday, released its assessment of the now-notorious ENHANCE trial—which tested whether Vytorin was better than simvastatin alone in reducing arterial plaque in a group of patients with severe genetic high cholesterol. It wasn’t, and publication of the study set off a firestorm of criticism of the drug and its promotional campaign.

According to FDA, the two-year study showed Vytorin had only a tiny difference in the in the growth of plaque compared with a simvastatin. Neither arm of the study showed much change at all—perhaps not a surprise in patients who suffered from unusually high levels of LDL cholesterol and had been treated previously. However, FDA was quick to point out that the level of LDL cholesterol dropped 56 percent in patients taking Vytorin, while the simvastatin group only showed a drop of 39 percent.

“The results from ENHANCE do not change FDA’s position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease,” a release from FDA stated. “Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications.”

The damage, however, might already be done. Sales of the Merck/Schering Plough drug plummeted through 2008, costing both companies billions in sales. The drug was also named as one of the reasons why Merck was forced to cut its workforce by up to 12 percent.

Vytorin is now being studied in the IMPROVE-IT trial, designed to determine whether the drug is any better than simvastatin alone in lowering the chance of major cardiovascular events. Results will be released after the trial ends in 2012.

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One Comment

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