BACKGROUND: Two isoforms of cyclooxygenase (COX) have been identified, both of them inhibited by traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Inhibition of @entity2247 has been associated with the therapeutic effects of NSAIDs, whereas inhibition of @entity9859 is believed to be the cause of the adverse gastrointestinal effects associated with NSAID therapy. When administered at therapeutic doses, new @entity2247 -specific inhibitors inhibit only the @entity2247 isoform. OBJECTIVE: This study sought to compare renal safety signals between the @entity2247 -specific inhibitors @entity13586 and @entity12698 , 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 @entity2247 -specific inhibitors were associated with renal-related ADRs. However, the adverse renal impact of @entity13586 was significantly greater than that of @entity12698 . IC values were significantly different for the following comparisons: water retention (1.97 @entity13586 vs 1.18 @entity12698 ; P < 0.01); @entity8 (2.38 vs 0.70; P < 0.01); @entity177 (2.22 vs 1.09; P < 0.01); @entity712 (2.39 vs 0.48; P < 0.01); and @entity101 (2.15 vs 1.33; P < 0.01). In an additional analysis, @entity12698 was shown to have a similar renal safety profile to that of @entity3522 and @entity5018 . CONCLUSIONS: Based on spontaneous ADR reports in the WHO/UMC safety database at the end of the second quarter 2000, this analysis indicates that @entity13586 has significantly greater @entity8 than @entity12698 or traditional NSAIDs. This negative renal impact may have the potential to increase the risk for serious cardiac and/or cerebrovascular events.

A comparison of renal-related adverse drug reactions between XXXX and @entity12698 , based on the World Health Organization/Uppsala Monitoring Centre safety database.

@entity13586 :: ('MESH:C116926', 'Chemical') :: ['rofecoxib'] @entity12698 :: ('MESH:C105934', 'Chemical') :: ['celecoxib'] @entity8 :: ('MESH:D007674', 'Disease') :: ['renal toxicity', 'abnormal renal function'] @entity712 :: ('MESH:D006333', 'Disease') :: ['cardiac failure'] @entity101 :: ('MESH:D006973', 'Disease') :: ['hypertension'] @entity3522 :: ('MESH:D004008', 'Chemical') :: ['diclofenac'] @entity5018 :: ('MESH:D007052', 'Chemical') :: ['ibuprofen'] @entity177 :: ('MESH:D051437', 'Disease') :: ['renal failure'] @entity9859 :: ('4512', 'Gene') :: ['COX-1'] @entity2247 :: ('4513', 'Gene') :: ['COX-2']
@entity13586 :: (MESH:C116926,Chemical) :: ['rofecoxib']
