NEJM: Too Soon To Dismiss Vytorin Cancer Connection

According to an editorial published in the New England Journal of Medicine, it is too early to rule out concerns about a possible Vytorin cancer connection that was identified in recent study data. The makers of Vytorin had previously sent a letter to healthcare providers dismissing the findings as likely attributed to chance.

Vytorin is a drug which combines ezetimibe (Zetia) and simvastatin (Zocor) to treat high levels of cholesterol in the blood. Although it was once a top seller for the drug’s makers, Merck & Co. and Schering-Plough Corp., sales have dropped sharply in recent months following multiple studies which question whether the medication provides any benefits over cheaper, older cholesterol drugs.

In July, data from a study known as SEAS, Simvastatin and Ezetimibe in Aoritic Stenosis, indicated that users of Vytorin had an increased incidence of cancer. Out of nearly 1,900 patients who were given Vytorin or a placebo, there were 105 reports of cancer among Vytorin users, compared to 70 reports of cancer among those taking the placebo. Although the data indicated an increased risk, the findings did not rise to the level of statistical significance.

After data from the study was released, Merck and Schering Plough sent a letter to healthcare providers dismissing the potential increased risk of cancer with Vytorin. A joint letter from the pharmaceutical companies indicated that they believe the cancer findings among Vytorin users in SEAS was an anomaly, and was not associated with the use of the drug.

Yesterday, the New England Journal of Medicine released a study online, which will be published in the September 25, 2008 issue, which contains an analysis of cancer data from the SEAS study and partial results from two other studies . Researchers concluded longer duration studies were needed to fully evaluate the Vytorin cancer risk, as most of the participants were followed for only a relatively short period of time for risks like cancer to emerge.

“Whether the increased mortality risk is due solely to the play of chance is uncertain,” concluded an editorial which accompanied the New England Journal of Medicine study. “The fact that the combined data from all three trials showed an increase in cancer mortality with ezetimibe should not be assumed to be a chance finding until further data are in.”

Last month the FDA issued an early communication to confirm that they are investigating the potential association between Vytorin side effects and cancer. At that time, the FDA indicated that they do not anticipate that their safety review will be complete until spring 2009, at which time they will make any decisions about whether regulator actions are warranted to protect the public.