FDA Review of Vytorin Deems Cancer Risk “Unlikely”

A recent Food and Drug Administration (FDA) review of clinical trial data has shown that Merck & Co.’s Vytorin, a popular cholesterol medication that combines Zocor (simvastatin) with Zetia (ezetimibe), does not necessarily raise the risk of cancer or cancer-related deaths.

The FDA announcement is a follow-up to concerns raised in August 2008, when early data from the SEAS drug trial showed an increased incidence of cancer in patients taking Vytorin (11.1 percent of study participants) versus those taking a placebo (7.5 percent of study participants).

“Based on the currently available information, FDA believes it is unlikely that Vytorin or Zetia increase the risk of cancer or cancer-related death, but at this time an association cannot be definitely ruled out,” stated the FDA report that was released on December 22, 2009.

The FDA review was based on data from the SEAS trial (Simvastatin and Ezetimibe in Aortic Stenosis), as well as two larger-scale studies of 20,000 patients that are set to conclude in the next few years. None of the trials were designed to investigate the possible cancer risk, but the FDA looked into the data to ensure ongoing trial safety.

The SEAS drug trial involved 1,873 patients with obstructed aortic heart valves to determine if the combination of simvastatin and ezetimibe in Vytorin could work better than simvastatin alone in decreasing levels of LDL (“bad”) cholesterol and reducing the risk of adverse cardiovascular events, such as heart attack or stroke. In addition to dismissing the link to cancer, the FDA determined that the SEAS trial did not show an overall lowered risk of cardiovascular events in those taking Vytorin as compared with those taking Zocor (simvastatin).

It is believed that statin medications, or HMG-CoA reductase inhibitors, such as Vytorin reduce the risk of heart attack and stroke by lowering LDL cholesterol levels, though there is little clinical evidence to show a direct link. While the combination medication Vytorin has been shown to lower LDL levels by 58 percent (as compared with 41 percent in patient taking simvastatin alone), the ENHANCE clinical trials from 2006 showed “no statistical difference between treatment groups” when the amount of arterial plaque buildup was examined.