FDA Issues Early Communication about an Ongoing Review of Vytorin

The U.S. Food and Drug Administration today issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study – the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) – on this cholesterol lowering drug. Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet.

The FDA is informing the public that the agency will conduct a review of Merck and Schering Plough’s recent trial once the FDA receives the final study results.

Merck/Schering Plough Pharmaceuticals issued a press release reporting preliminary results of the study and stated that the study demonstrated no significant differences between the combination product and Zocor on the build up of cholesterol plaque in the carotid (neck) arteries. The study was not designed to detect any difference in risk of having a heart attack or stroke between the two treatments. An ongoing trial called -- Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT) -- is underway which is designed to evaluate the effect of Vytorin versus Zocor on heart disease and stroke.

This Early Communication is in keeping with the FDA's commitment to inform the public about its ongoing review of drugs. Until the FDA reviews the data, the agency advises patients to talk with their health care providers if they have questions about the ENHANCE study.

Full text of the Early Communication about an Ongoing Data Review for the ENHANCE Study can be found at: http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm.

---