PMID- 23506230 OWN - NLM STAT- MEDLINE DCOM- 20140331 LR - 20220311 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 12 IP - 4 DP - 2013 Jul TI - Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials. PG - 465-77 LID - 10.1517/14740338.2013.780595 [doi] AB - 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. FAU - Essex, Margaret Noyes AU - Essex MN AD - US Medical Affairs, Pfizer Inc., 235 E. 42nd Street, New York, NY 10017, USA. Margaret.essex@pfizer.com FAU - Zhang, Richard Y AU - Zhang RY FAU - Berger, Manuela F AU - Berger MF FAU - Upadhyay, Sameer AU - Upadhyay S FAU - Park, Peter W AU - Park PW LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't DEP - 20130319 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 0 (Cyclooxygenase 2 Inhibitors) RN - 0 (Pyrazoles) RN - 0 (Sulfonamides) RN - JCX84Q7J1L (Celecoxib) SB - IM EIN - Expert Opin Drug Saf. 2013 Nov;12(6):913 MH - Aged MH - Aged, 80 and over MH - Anti-Inflammatory Agents, Non-Steroidal/*adverse effects/therapeutic use MH - Celecoxib MH - Clinical Trials as Topic MH - Cyclooxygenase 2 Inhibitors/*adverse effects/therapeutic use MH - Female MH - Humans MH - Inflammation/drug therapy MH - Male MH - Middle Aged MH - Pain/drug therapy MH - Pyrazoles/*adverse effects/therapeutic use MH - Randomized Controlled Trials as Topic MH - Sulfonamides/*adverse effects/therapeutic use EDAT- 2013/03/20 06:00 MHDA- 2014/04/01 06:00 CRDT- 2013/03/20 06:00 PHST- 2013/03/20 06:00 [entrez] PHST- 2013/03/20 06:00 [pubmed] PHST- 2014/04/01 06:00 [medline] AID - 10.1517/14740338.2013.780595 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2013 Jul;12(4):465-77. doi: 10.1517/14740338.2013.780595. Epub 2013 Mar 19.