Safety Alerts & Recalls

What does this mean?

Although the results from ENHANCE did not show an effect on arterial plaque build up, the FDA maintains the position that a high LDL cholesterol is a risk factor for heart disease and that lowering LDL cholesterol reduces the risk for heart disease. Thus, if you have a history of high cholesterol, you should continue to take Zetia or other cholesterol lowering medications. Please contact your doctor for more information if you have any questions about Zetia, the ENHANCE trial, or the treatment of your high cholesterol.

FDA Issues Final Review of ENHANCE Study

In January 2008, the FDA announced it would review results from the ENHANCE trial, a study conducted in patients with heterozygous familial hypercholesterolemia (HeFH) - a condition associated with very high cholesterol levels that affects approximately 0.2 percent of the population. This study compared the change in arterial plaque build up (a risk factor for heart disease) in patients taking Vytorin and in patients taking simvastatin alone. Vytorin is a cholesterol lowering medicine that contains ezetimibe (marketed as Zetia) and simvastatin (marketed as Zocor).

The FDA has now completed its review of the final study report of ENHANCE. After two years of treatment, patients taking Vytorin had similar amounts of arterial plaque build up as patients taking simvastatin alone - even though the patients taking Vytorin had lower LDL cholesterol levels.

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Source: FDA
Publication Date: 2009-01-09
Last Updated: 2009-12-05

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