Is the use of the combination of ezetimibe/simvastatin associated with causing cancer?
SEAS Results Alarming The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial randomized 1873 patients to ezetimibe/simvastatin (Vytorin) 10 mg/40 mg or placebo for a mean of 4.1 years.1 The trial results were alarming because a statistically significantly increased incidence in new onset of cancer was observed in patients randomized to ezetimibe/simvastatin (101 patients) compared with placebo (65 patients, uncorrected p=0.006).1,2 The cancers were not clustered in any one particular area, with increases seen in prostate, skin, gastrointestinal, and other types of cancers. SHARP and IMPROVE-IT Analyzed These results prompted Richard Peto, Oxford University, and colleagues to compare the incidence of cancer from the SEAS trial with the combined incidence observed in 2 currently on-going trials: the Study of Heart and Renal Protection (SHARP) trial and the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT).2 The analysis was published on-line on Sept