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Vytorin is an example of a cholesterol-lowering medication that contains both a cholesterol absorption inhibitor (ezetimibe) and a statin drug (simvastatin). Vytorin was approved by the U.S. Food and Drug Administration (FDA)in 2004 and is indicated to reduce high LDL-cholesterol levels.

In November 2008, the FDA issued an early communication that it is investigating a possible association between the use of Vytorin and a potentially increased incidence of cancer. The FDA obtained preliminary data from a clinical trial known as the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) indicating that a larger percentage of test subjects treated with Vytorin died from all types of cancer when compared to subjects who were taking a placebo during the 5-year SEAS study.

The purpose of the SEAS study was to determine whether lowering LDL-cholesterol levels with Vytorin would reduce the risk of cardiovascular events (i.e., heart attack; stroke) in patients with aortic stenosis - a narrowing of the opening of the aortic valve in the heart. A lower overall cardiovascular risk was not found for subjects taking Vytorin during the study. A possible association between the use of Vytorin and a potentially increased incidence of cancer was an additional observation during the 5-year study period.

The FDA anticipates receiving a final SEAS study report in December 2008 and the Agency's review and evaluation of the clinical trial data is expected to take an additional 6 months. FDA will communicate its conclusions and recommendations at that time. In the meantime, health care professionals and caregivers should continue to monitor patients taking Vytorin and report side-effects from the use of this drug to the FDA.

This information reflects the FDA's current analysis of available data concerning Vytorin. Disseminating this information does not mean that FDA has concluded there is a causal relationship between Vytorin and cancer. Nor does it mean that FDA is advising health care professionals to discontinue prescribing Vytorin. FDA is considering but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this information when additional data becomes available.

Postmenopausal Hormone Therapy

In the past, hormone therapy (estrogen plus progestin) was used as a means of lowering cholesterol in many postmenopausal women. This practice, however, has been abandoned due to the results of more recent studies, particularly the Women's Health Inititative, which indicated that hormone therapy increases the risk of developing heart disease, breast cancer, and other complications.