A comparison of renal-related adverse drug reactions between rofecoxib and celecoxib, based on the World Health Organization/Uppsala Monitoring Centre safety database

Sean Z. Zhao, Matthew W. Reynolds, James Lefkowith, Andrew Whelton, Felix M. Arellano

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Two isoforms of cyclooxygenase (COX) have been identified, both of them inhibited by traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Inhibition of COX-2 has been associated with the therapeutic effects of NSAIDs, whereas inhibition of COX-1 is believed to be the cause of the adverse gastrointestinal effects associated with NSAID therapy. When administered at therapeutic doses, new COX-2-specific inhibitors inhibit only the COX-2 isoform. Objective: This study sought to compare renal safety signals between the COX-2-specific inhibitors rofecoxib and celecoxib, based on spontaneous reports of adverse drug reactions (ADRs) in the World Health Organization/Uppsala Monitoring Centre (WHO/UMC) safety database through the end of the second quarter 2000. Methods: Disproportionality in the association between a particular drug and renal-related ADR was evaluated using a bayesian confidence propagation neural network method in which a statistical parameter, the information component (IC) value, was calculated for each drug-ADR combination. In this method, an IC value significantly greater than 0 implies that the association of a drug-ADR pair is stronger than background; the higher the IC value, the more the combination stands out from the background. The ratio of actual to expected numbers of ADRs was also used to assess disproportionality. Results: As with traditional NSAIDs, both COX-2-specific inhibitors were associated with renal-related ADRs. However, the adverse renal impact of rofecoxib was significantly greater than that of celecoxib, IC values were significantly different for the following comparisons: water retention (1.97 rofecoxib vs 1.18 celecoxib; P

Original languageEnglish (US)
Pages (from-to)1478-1491
Number of pages14
JournalClinical Therapeutics
Volume23
Issue number9
DOIs
StatePublished - 2001

Keywords

  • Acute renal failure
  • Cardiovascular disorders
  • Celecoxib
  • COX- 2-specific inhibitors
  • Rofecoxib
  • Spontaneous reports

ASJC Scopus subject areas

  • Pharmacology

Fingerprint Dive into the research topics of 'A comparison of renal-related adverse drug reactions between rofecoxib and celecoxib, based on the World Health Organization/Uppsala Monitoring Centre safety database'. Together they form a unique fingerprint.

Cite this