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Celecoxib was similar to naproxen for rheumatoid arthritis with fewer endoscopic ulcers

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 QUESTION: In patients with rheumatoid arthritis (RA), is celecoxib as efficacious (in anti-inflammatory and analgesic effects) and safe (in avoiding endoscopic upper gastrointestinal [GI] ulcers) as naproxen?


Randomised (allocation concealed*), blinded (patients, clinicians, and outcome assessors),* placebo controlled, 12 week trial.


79 US and Canadian clinical sites.


1149 patients (mean age 54 y, 73% women) who had RA (American College of Rheumatology criteria) for >3 months. Inclusion criteria were age ≥18 years and receipt of stable medications; oral steroids and disease modifying antirheumatic drugs were allowed. Exclusion criteria were active GI tract, renal, hepatic, or coagulation disorders; history of cancer or gastric or duodenal surgery; or recent or current oesophageal or gastroduodenal ulcers or ≥10 erosions. 60% of patients completed the study; follow up was >99%.


Symptomatic RA was confirmed after non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics were stopped for 2 to 7 days. Patients were then allocated to celecoxib, 100 mg twice/d (n=240), 200 mg twice/day (n=235), or 400 mg twice/day (n=218); naproxen, 500 mg twice/day (n=225); or placebo (n=231). NSAIDs, injectable corticosteroids, …

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  • Source of funding: GD Searle & Co.

  • For correspondence: Dr LS Simon, Beth Israel Deaconess Medical Center, 110 Francis Street, Suite 5C, Boston, MA 02215, USA. Fax +1 617 632 7795.

  • * See glossary.