title: Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials.
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.
authors.affiliation: US Medical Affairs, Pfizer Inc., 235 E. 42nd Street, New York, NY 10017, USA. Margaret.essex@pfizer.com
authors.forename: Margaret Noyes
authors.initials: MN
authors.lastname: Essex
authors.forename: Richard Y
authors.initials: RY
authors.lastname: Zhang
authors.forename: Manuela F
authors.initials: MF
authors.lastname: Berger
authors.forename: Sameer
authors.initials: S
authors.lastname: Upadhyay
authors.forename: Peter W
authors.initials: PW
authors.lastname: Park
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use; D000068579:Celecoxib; D002986:Clinical Trials as Topic; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy; D011720:Pyrazoles / Q000009:adverse effects* / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D013449:Sulfonamides / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib