Merck & Co (MRK) Announced Preliminary Analyses of MEDAL
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Merck & Co (NYSE: MRK) announced 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 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. In the "intent-to-treat" analysis, the relative risk of confirmed thrombotic CV events between ARCOXIA and diclofenac was 1.05, consistent with the primary per-protocol analysis.
"After four years of conducting this arthritis study program in more than 34,000 patients, we are looking forward to sharing the full MEDAL Program results in the future," said Dr. Peter S. Kim, president, Merck Research Laboratories.
Analyses of the data are ongoing. As previously planned, full results of the MEDAL Program, which began in 2002, will be disclosed in a scientific peer-reviewed publication and in presentations at scientific meetings.
Conducted in 38 countries, the MEDAL Program is the first arthritis study program designed with CV safety as its primary endpoint, and is the largest and longest controlled clinical assessment of a selective COX-2 inhibitor vs. a traditional NSAID in an arthritis patient population.
"After four years of conducting this arthritis study program in more than 34,000 patients, we are looking forward to sharing the full MEDAL Program results in the future," said Dr. Peter S. Kim, president, Merck Research Laboratories.
Analyses of the data are ongoing. As previously planned, full results of the MEDAL Program, which began in 2002, will be disclosed in a scientific peer-reviewed publication and in presentations at scientific meetings.
Conducted in 38 countries, the MEDAL Program is the first arthritis study program designed with CV safety as its primary endpoint, and is the largest and longest controlled clinical assessment of a selective COX-2 inhibitor vs. a traditional NSAID in an arthritis patient population.
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