In a new article released online (ahead of print) in the New England Journal of Medicine (SEAS Trial), Schering-Plough’s “would be” blockbuster drug ezitimibe (Zetia) has again not only fallen short of it’s expectations, but now may also be linked with increased cancer risk.
In patients taking Vytorin (simvastatin + ezitimibe) there was an increased number of cancers (no particular type) when it was given to try to prevent aortic stenosis (thickening of a valve located in the blood outflow tract in the heart).
Aortic stenosis in elderly is related to atherosclerosis and has many of the same risk factors as for heart attacks. This trial was therefore designed to see if Vytorin could prevent/delay development of aortic stenosis. Unfortunately, Vytorin fell short in this criterion also.
Of note, another article published online, analyzed data from 2 more trials (which are ongoing - SHARP , IMPROVE-IT) in addition to the SEAS trial and concluded that there may not be any relationship of Vytorin with cancer. However, both the other studies are sponsored by Schering-Plough!!!!!
But these articles most likely will drive the nail in the coffin for Vytorin.
Reference: NEJM