Q&A

What are the risks of long-term NSAIDs and COX-2 inhibitors?

J Fam Pract. 2003 March;52(3):183-200
By
Michael DeBisschop, PharmD
Author and Disclosure Information

  • BACKGROUND: Much of the widespread use of COX-2 inhibitors is due to the perception that they are safer than traditional NSAIDs. However, in terms of patient-oriented outcomes, their real safety is unknown.
  • POPULATION STUDIED: The patient population being analyzed is the same as in the CLASS and VIGOR studies: adults with osteoarthritis and rheumatoid arthritis. The author reanalyzed results from these 2 studies only.
  • STUDY DESIGN AND VALIDITY: This was not a systematic review; no literature searches were performed or inclusion criteria described. The author apparently extracted data from the FDA’s public reports on the full, long-term results of both the CLASS and VIGOR studies. These data were used to provide separate and pooled estimates of adverse events for each study.
  • OUTCOMES MEASURED: The author reported total mortality, serious adverse events (death, hospital admission, life-threatening events), and complicated ulcers for each study individually and a pooled estimate for both studies (median duration of 9 months).
  • RESULTS: There was no significant difference in overall mortality between traditional NSAIDs and COX-2 inhibitors for either study or in the pooled estimate. The risk of serious adverse events was significantly higher (absolute risk increase =1.3%; number needed to harm [NNH]=78) in the pooled estimate as well as the rofecoxib study, but not in the celecoxib study. The risk of complicated ulcers was significantly lower in the rofecoxib study (absolute risk decrease=0.52%; NNH=192), but not in the celecoxib study or the pooled estimate. No P values or confidence intervals were presented.
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PRACTICE RECOMMENDATIONS

This review presents an interesting new analysis of cyclo-oxygenase-2 (COX-2) inhibitor safe-ty, concluding that long-term use results in more serious adverse events than traditional nons-teroidal anti-inflammatory drugs (NSAIDs).

The nonsystematic and retrospective properties of this analysis limit its validity. However, the fact that an evaluation of long-term data found some small harm to COX-2 inhibitors relative to traditional NSAIDs (number needed to harm=78 over 9 months) should give clinicians pause. Until better meta-analyses or new safety data are published, clinicians should prescribe COX-2 inhibitors long-term only for those patients deemed to be at high risk of ulcer complications.

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