Critical Lessons From the ENHANCE Trial

THE UNUSUAL RELEASE ON JANUARY 14, 2008, IN THE news media and on a drug company Web site, of a portion of the Effect of Ezetimibe Plus Simvastatin Versus Simvastatin Alone on Atherosclerosis in the Carotid Artery (ENHANCE) trial data resulted in numerous articles and commentaries in the lay media. The availability of only fragmentary information created massive confusion and raised many more questions than answers for patients, physicians, pharmaceutical companies, and regulators. A full report of the ENHANCE trial in a peerreviewed medical journal is not expected for months, and the first public presentation of the study’s findings in a medical setting will not occur before late March 2008. The purpose of this Commentary is to review key features of the ENHANCE study and to point to lessons that should be learned by drug companies, clinical researchers, clinicians, and health agencies from this unfortunate medical research experience.