The ENHANCE trial

To the Editor: Dr. Davidson concludes his article saying “we should remember [that ezetimibe] is safe and well-tolerated.” Yet, he admits there is a lack of outcomes data for the drug. So, how does he know it is safe if we don’t have the mortality outcomes? The just-published Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial indicated that there may be an increase in cancer mortality.¹ The point is that we need more data. Until we have that outcomes data we should not be saying a drug is safe as a matter of fact. Physicians need to learn the lessons we should have learned from drugs such as torcetrapib² or erythropoietin³ and so many others. We often think we are doing a good thing by correcting lab values, but we often learn too late that we harmed the patient at a staggering ethical and financial cost.

Dr. Davidson also references the impressive LDL-C lowering of Senator McCain while taking ezetimibe. Senator McCain has a publicized history of melanoma. Hopefully, ezetimibe doesn’t increase his cancer mortality risk because his physicians are proud of his LDL-C lowering. My advice to the senator is to use one of the many other proven methods of LDL-C lowering until there is good mortality outcome data with ezetimibe (but I’m not a Republican, so he may want to get a second opinion).