Merck Arcoxia Outcomes Study Designs May Confound Results, FDAer Says
This article was originally published in The Pink Sheet Daily
Executive Summary
Use of concomitant aspirin and prior use of other COX-2 inhibitors are among the design "maneuvers" that may make interpretation of data difficult, FDA reviewer says. Merck touts EDGE II and MEDAL as large outcomes studies that will address questions about safety of coxibs versus traditional NSAIDs when data become available in 2006.