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Based on the experience with selective cyclooxygenase COX -2 inhibitors, including rofecoxib, valdecoxib, and celecoxib, it was anticipated that etoricoxib, a new selective COX-2 inhibitor, would display mechanism-based, dose-dependent renal adverse effects AEs similar to those observed with nonselective non-steroidal anti-inflammatory drugs NSAIDs in long-term treatment. The etoricoxib program database included data from 8 placebo-controlled Phase III studies of osteoarthritis, rheumatoid arthritis, and chronic low back pain. As part of the program-wide assessment of etoricoxib, the investigator-reported incidence of and discontinuations due to renal AEs, including hypertension, lower-extremity edema LEE, elevated serum creatinine concentration SCC, and congestive heart failure CHF were examined. Data from patients were included in the analysis. Most patients were women
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Nonsteroidal antiinflammatory drugs NSAIDs, including selective cyclooxygenase COX -2 inhibitors, have come to play an important role in the pharmacologic management of arthritis and pain. Clinical trials have established the efficacy of etoricoxib in osteoarthritis, rheumatoid arthritis, acute gouty arthritis, ankylosing spondylitis, low back pain, acute postoperative pain, and primary dysmenorrhea. Etoricoxib was generally well tolerated in these studies with no new safety findings during long-term administration. The gastrointestinal, renovascular, and cardiovascular tolerability profiles of etoricoxib have been evaluated in large patient datasets, and further insight into the cardiovascular tolerability of etoricoxib and diclofenac will be gained from a large ongoing cardiovascular outcomes program MEDAL. The available data suggest that etoricoxib is an efficacious alternative in the management of arthritis and pain, with the potential advantages of convenient once-daily administration and superior gastrointestinal tolerability compared with traditional NSAIDs. Musculoskeletal conditions are often progressive and associated with considerable pain and disability WHO
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COX-2 selective inhibitors are not a substitute for acetylsalicylic acid for prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet effect. Ankylosing spondylitis The recommended dose is 60 mg once daily.
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Metrics details. Both doses of etoricoxib were non-inferior to naproxen. All treatments were well tolerated.
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