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news.Merck & Co has reported preliminary data from an arthritis study program comparing its potential Vioxx successor Arcoxia and diclofenac, a traditional non-steroidal anti-inflammatory drug.
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According to Merck, preliminary analyses indicate that the program, named MEDAL, showed the rate of confirmed thrombotic cardiovascular (CV) events to be similar between Arcoxia and diclofenac.
However, significantly more Arcoxia patients withdrew from the study than their diclofenac counterparts due to side effects relating to high blood pressure, edema and congestive heart failure.
Analyses of the data are ongoing. Merck said that 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.
The company also revealed that it intends to respond to the approvable letter issued by the FDA for Arcoxia and will include the results of the MEDAL program as part of that response.