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Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials

BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7365.619 (Published 21 September 2002) Cite this as: BMJ 2002;325:619
  1. Jonathan J Deeks (jon.deeks{at}cancer.org.uk), senior medical statisticiana,
  2. Lesley A Smith, research fellowa,
  3. Matthew D Bradley, associate directorb
  1. a Centre for Statistics in Medicine, Institute of Health Sciences, Headington, Oxford OX3 7LF
  2. b Pfizer Global Research and Development, Sandwich, Kent CT13 9NJ
  1. Correspondence to: J J Deeks
  • Accepted 27 March 2002

Abstract

Objective: To determine the efficacy, gastrointestinal safety, and tolerability of celecoxib (a cyclo-oxygenase 2 (COX 2) inhibitor) used in the treatment of osteoarthritis and rheumatoid arthritis.

Design: Systematic review of randomised trials that compared at least 12 weeks' celecoxib treatment with another non-steroidal anti-inflammatory drug (NSAID) or placebo and reported efficacy, tolerability, or safety. Trials identified from manufacturer and by searching electronic databases and evaluated according to predefined inclusion and quality criteria. Data combined through meta-analysis.

Participants: 15 187 patients with osteoarthritis or rheumatoid arthritis.

Main outcome measures: Efficacy: Western Ontario and McMaster universities osteoarthritis index; American College of Rheumatology responder index and joint scores for rheumatoid arthritis. Tolerability: withdrawal rates for adverse effects. Gastrointestinal safety: incidence of ulcers, bleeds, perforations, and obstructions.

Results: Nine randomised controlled trials were included. Celecoxib and NSAIDS were equally effective for all efficacy outcomes. Compared with those taking other NSAIDs, in patients taking celecoxib the rate of withdrawals due to adverse gastrointestinal events was 46% lower (95% confidence interval 29% to 58%; NNT 35 at three months), the incidence of ulcers detectable by endoscopy was 71% lower (59% to 79%; NNT 6 at three months), and the incidence of symptoms of ulcers, perforations, bleeds, and obstructions was 39% lower (4% to 61%; NNT 208 at six months). Subgroup analysis of patients taking aspirin showed that the incidence of ulcers detected by endoscopy was reduced by 51% (14% to 72%) in those given celecoxib compared with other NSAIDs. The reduction was greater (73%, 52% to 84%) in those not taking aspirin.

Conclusion: Celecoxib is as effective as other NSAIDs for relief of symptoms of osteoarthritis and rheumatoid arthritis and has significantly improved gastrointestinal safety and tolerability.

Footnotes

  • Funding Additional funding was provided to the Centre for Statistics in Medicine by Pfizer and Searle (now part of Pharmacia).

  • Competing interests The review was undertaken independently at the Centre for Statistics in Medicine. LAS is employed on a fellowship funded by Pfizer. JJD has acted as a paid consultant to Pfizer and Pharmacia. MDB is an employee of Pfizer. The review was prepared as part of the submission to the UK National Institute of Clinical Excellence for appraisal of COX 2 selective inhibitors.

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