Vytorin coronary syndrome trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Merck/Schering-Plough are initiating a 10,000-patient trial to evaluate the efficacy of their Zetia/Zocor combo Vytorin (ezetimibe/simvastatin) in reducing morbidity and mortality in high-risk acute coronary syndrome patients, the firms announce Nov. 9. IMPROVE IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) will compare Vytorin 10 mg/40 mg to Zocor 40 mg for the composite primary endpoint of death, myocardial infarction, rehospitalization for ACS or revascularization. The study follows Merck's "A to Z" trial of Zocor in ACS, which signaled an increased risk of myopathy with Zocor 80 mg...