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THU0175 The celecoxib long-term arthritis safety study (class): celecoxib is associated with less renal toxicity compared to conventional nonsteroidal anti-inflammatory drugs (nsaids)
  1. A Whelton1,2,3 On Behalf of the CLASS Investigators On Behalf of the CLASS Investigators
  1. 1Universal Clinical Research Center, Inc., Hunt Valley
  2. 2Johns Hopkins Medical School, Baltimore
  3. 3Pharmacia Corporation, Skokie, USA


Objectives Conventional NSAIDs, which nonselectively inhibit cyclooxygenase (COX)-1 and COX-2, are associated with deleterious effects on renal function such as reductions in glomerular filtration rate and sodium retention. Celecoxib specifically inhibits COX-2. Such specific inhibition raises the possibility that the incidence of renal toxicity vs conventional NSAIDs may be reduced.

Methods In a randomised, double-blind trial with exposures of up to 15 months, 7968 patients with osteoarthritis (OA) (n = 5746) or rheumatoid arthritis (RA) (n = 2183) were randomised to receive supratherapeutic doses of celecoxib (400 mg BID; n = 3,987) vs ordinary therapeutic doses of conventional NSAIDs: ibuprofen (800 mg TID; n = 1996) or diclofenac (75 mg BID; n = 1985).

Results Fewer celecoxib-treated patients experienced renal toxicity compared to patients treated with NSAIDs (see Table 1; *p < 0.05 vs celecoxib, **serum creatinine levels above 2 mg/dL and/or BUN values above 40 mg/dL).

Abstract THU0175 Table 1

Conclusion Celecoxib at supratherapeutic doses was associated with a lower incidence of renal toxicity compared to conventional NSAIDs at ordinary therapeutic doses.

Sponsored by Pharmacia Corporation and Pfizer, Inc.

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