Merck & Co., Inc. Provides Preliminary Analyses Of The Completed MEDAL Program For ARCOXIA(TM) (Etoricoxib); Merck Looks Forward To Reviewing The MEDAL Program Data With Regulatory Agencies And Intends To Respond To FDA-Issued ''Approvable'' Letter
Published: Aug 23, 2006
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Aug. 23, 2006-- Merck & Co., Inc. announced today that preliminary analyses indicate the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program showed that the rate of confirmed thrombotic cardiovascular (CV) events was similar between the selective COX-2 inhibitor ARCOXIA(TM) and diclofenac, a traditional nonsteroidal anti-inflammatory drug (NSAID). Specifically, in the pre-specified "per-protocol" analysis of the primary endpoint, the relative risk of confirmed thrombotic CV events between ARCOXIA and diclofenac was 0.95 (95 percent CI: 0.81, 1.11). In the "intent-to-treat" analysis, the relative risk of confirmed thrombotic CV events between ARCOXIA and diclofenac was 1.05 (95 percent CI: 0.93, 1.19), consistent with the primary per-protocol analysis.