Will Negative Media Hype on Vytorin eventually harm patients?

Is the media hyping the negative result of the ENHANCE study beyond the actual scientific evidence available? We believe so, and so does FDA’s Center for Drug Evaluation and Review Office of Medical Policy director Robert Temple.

In an interview with FDAWebview, he comments: “The only ‘finding’ I’m aware of is failure to show an added effect on carotid plaques, a surrogate endpoint at best, and one that rates, as a surrogate for predicting coronary events, in my book below LDL cholesterol, in a study that was far too small to be an outcome study. It does appear that the ezetimibe did lower CRP (c-reactive protein) some, something many people would think desirable.”

Dr Temple is also concerned that the continuing backlash on cholesterol drugs may affect the use of statins:” As the recent Crestor story remind us (for people without known cardiac disease, by the way) we sure do know it is beneficial and people who need that treatment will pay with their lives if they’re encourage to avoid treatment”.

The bottom line is that, while full outcome data will not be available for several years, Vytorin is safe and physicians may want to consider the glass half full and offer the potential additional benefits of ezetimibe in addition to simvastatin to all appropriate patients.