Author(s): Essex MN, Zhang RY, Berger MF, Upadhyay S, Park PW
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Abstract OBJECTIVE: Further understand the safety profile of celecoxib and provide safety information for important adverse events (AEs). METHODS: Analysis of randomized controlled trials from the Pfizer clinical trial repository (final study reports completed by 31 July 2011) in which celecoxib was compared with placebo or non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) for treatment of pain or inflammation in adults. Safety end points comprised 18 terms that had been identified as important AEs among all NSAIDs. RESULTS: There was a greater risk of edema (risk difference (95\% confidence interval) 0.77\% (0.45, 1.09)); hypertension (0.28\% (-0.01, 0.57)); angioedema (0.16\% (-0.06, 0.39) and allergic reactions (0.15\% (-0.10, 0.40)) with celecoxib than with placebo, while a greater risk of gastrointestinal (GI) hemorrhage (-0.15\% (-0.47, 0.16)) was seen with placebo. There was a greater risk of GI hemorrhage (-0.53\% (-0.72, -0.33)), GI ulceration (-0.46\% (-0.60, -0.33)), edema (-0.62\% (-0.89, -0.35)) and hypertension (-0.57\% (-0.82, -0.33)) with nsNSAIDs than with celecoxib. CONCLUSIONS: The magnitude of risks associated with NSAIDs is small and similar in celecoxib-, nsNSAID- and placebo-treated patients. This analysis provides safety information that will allow physicians to make informed treatment decisions for patients who are appropriate candidates for celecoxib use.
This article was published in Expert Opin Drug Saf
and referenced in Journal of Bioequivalence & Bioavailability