Long-awaited study analysis for Arcoxia (etoricoxib), a COX-2 inhibitor Merck & Co. hope will be the successor to Vioxx, has yielded both positive and negative results based on preliminary review. The MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program consisted of three clinical trials - EDGE, EDGE II, and MEDAL. The longest of the three studies, the MEDAL study, assessed data in over 23,000 patients with osteoarthritis and rheumatoid arthritis.
In the MEDAL study, study participants given 60 or 90 mg. Arcoxia daily were compared to study participants given 150 mg. diclofenac daily. Preliminary reports indicate that:
- the rate of heart attacks and strokes due to blood clots was similar for patients taking Arcoxia versus patients taking diclofenac.
- the number of patients who withdrew from the study due to side effects (high blood pressure, edema, and congestive heart failure) was significantly higher for the patients taking Arcoxia than patients taking diclofenac.
Opinions vary regarding what comes next based on the results. Merck reports it will fully review the MEDAL program data with regulatory agencies. Arcoxia is already approved in 62 countries in Europe, Latin America, the Asia-Pacific region, and Middle East/Northern Africa.
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