Evidence Based Snapshots

The Journal of Informed Pharmacotherapy 2003;12:152.

Celecoxib versus Diclofenac and Omeprazole in reducing the risk of Recurrent Ulcer Bleeding in Patients with Arthritis

Reviewer: James McCormack, B.Sc. (Pharm), Pharm. D.
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Associate Editor, Journal of Informed Pharmacotherapy

Original Citation

Chan FK, Hung LC, Suen BY, Wu JC, Lee KC, Leung VK, Hui AJ, To KF, Leung WK, Wong VW, Chung SC, Sung JJ. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med 2002;347:2104-10. PubMed Citation

Overall Study Question

These investigators compared celecoxib to diclofenac plus omeprazole for the treatment of arthritis.  The primary outcome was recurrent ulcer bleeding.  Secondary outcomes were efficacy, recurrent ulcer bleeding in those patients not taking low-dose aspirin, and other adverse drug effects.


287 patients with arthritis who had presented with a bleeding ulcer.  Their mean age was 67.  45% of the participants were women, 87% had osteoarthritis, 12% were smokers, 22% had a creatinine greater than 106 mmoles/L, 9% used concomitant aspirin and 53% had a previous H. pylori infection.


After their ulcers were healed, patients were randomized in a blinded fashion to receive either 200 mg of celecoxib twice daily plus placebo or 75 mg daily of diclofenac twice daily plus 20 mg of omeprazole. 


The duration of treatment was 6 months. 


Efficacy for arthritis
There was no difference between the groups in patients' global assessment of disease activity or in arthritis pain.

Outcomes and Adverse Effects

NSS = not statistically significant, * = progressive rise in creatinine above 200 mmoles/L

How does this study contribute to the drug therapy of patients with previous gastrointestinal bleeds who require chronic NSAIDs?

This study suggests that there is no difference between using celecoxib or a combination of diclofenac and omeprazole in preventing recurrent gastrointestinal bleeds, and that the chance of a recurrent bleed is approximately 5% over a period of 6 months in this patient population.  In addition, this study revealed that renal adverse events can be expected to occur in approximately 25% of patients receiving either celecoxib or diclofenac.

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