|FDA to investigate SEAS trial. Source: www.nj.com|
The FDA is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial about a possible association between the use of Vytorin and an increased incidence of cancer.
Last month, the SEAS trial results revealed that administering Vytorin in patients with mild to moderate aortic stenosis reduces the risk of coronary artery disease events, but did not lower overall cardiovascular risk. However, there was an additional observation that a larger percentage of subjects treated with Vytorin were diagnosed with, and died from, all types of cancer, when compared to placebo during the five-year study.
Vytorin, manufactured and distributed by Merck and Schering-Plough, is a combination product of simvastatin and ezetimibe used to decrease the production of cholesterol by the liver and inhibit the absorption of cholesterol in the intestine to reduce LDL-cholesterol levels and reduce the risk of cardiovascular events.
The FDA said it recently obtained preliminary results from the SEAS trial and anticipates receiving a final SEAS study report in about the months. Review and evaluation of the clinical trial data and other relevant information should take approximately six months, at which time the FDA said it will communicate its “conclusions and recommendations.”