Jill Cotter and Eric Wooltorton suggest an approach to prescribing COX-2 inhibitors that includes estimating cardiac risk, using the lowest doses for short periods, and discussing the risks and benefits of long-term use. They provide evidence for the cardiovascular risks of celecoxib.1 Regarding the benefits, it is helpful to review the results of the CLASS trial,2 which was designed to evaluate the efficacy of celecoxib in reducing clinically significant upper gastrointestinal (GI) adverse events.
CLASS reported the pooled results of 2 trials comparing celecoxib, 400 mg twice a day, with diclofenac, 75 mg twice a day, and ibuprofen, 800 mg three times a day. The study protocol prespecified that the results would be pooled, but an FDA report3 gave the results separately for diclofenac and ibuprofen, for the full length of the 2 studies, 12 months and 15 months, whereas the published CLASS study reported 6-month data.
The FDA report concludes that the CLASS trial was a robust testing of the safety of celecoxib at doses 2 and 4 times those currently labelled for rheumatoid arthritis and osteoarthritis, respectively; celecoxib does not appear to be more effective for treating the signs and symptoms of osteoarthritis or rheumatoid arthritis than the NSAID comparators; and celecoxib did not show statistically significant superiority to diclofenac at any point in the trial regardless of ASA use or end point (including the primary end point of clinically significant upper GI events, namely, upper GI bleeding, perforation, or gastric outlet obstruction alone or with gastroduodenal ulcers).
With little indication of benefit in symptom control or reduction of adverse events, it is questionable whether there is a need to prescribe celecoxib at all.
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Competing interests: None declared.