Q&A

What is the best NSAID regimen for arthritis patients with bleeding ulcer?

J Fam Pract. 2003 May;52(5):349-364
By
Eric A. Jackson, PharmD
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  • BACKGROUND: Patients who take NSAIDs for arthritis are at high risk for bleeding ulcers because of their age, functional disability, and the long-term nature of NSAID use. Patients with a history of ulcer bleeding who use NSAIDs are at the highest risk of ulcer complications. Previous studies have shown that adding a proton pump inhibitor (PPI) or misoprostol to a traditional NSAID reduces ulcer recurrence.
  • POPULATION STUDIED: The researchers enrolled 290 arthritis patients who presented with a bleeding ulcer to an endoscopy center in Hong Kong, China. The average age of these Chinese patients was 68 years, 63% were male, and most (58%) had gastric ulcers. After randomization, treatment groups were relatively well matched for characteristics that would affect the outcome of interest.
  • STUDY DESIGN AND VALIDITY: This was a prospective, double-blind trial in which patients with healed ulcers were randomized to receive either celecoxib 200 mg twice daily plus placebo once daily (n=144) or extended-release diclofenac 75 mg twice daily plus omeprazole 20 mg once daily (n=143) for 6 months. Double-blinding was maintained by repackaging all medications and placebo in identical capsules.
  • OUTCOMES MEASURED: The primary outcome was recurrent ulcer bleeding within 6 months. Prespecified criteria for bleeding ulcer included clinical or laboratory evidence confirmed by endoscopy. Secondary outcomes included treatment efficacy (based on patients’ global assessment of disease activity and arthritis pain), recurrent ulcer bleeding in those patients not taking low-dose aspirin, and other adverse events.
  • RESULTS: Three of the 290 patients originally enrolled in the study withdrew consent before taking any medication, leaving 287 patients in the intention-totreat analysis. At the end of the study period, the probability of recurrent ulcer bleeding was similar between groups, about 5%. Patients’ assessments of arthritis activity and pain did not differ between the groups at any visit. Recurrence rates were similar in patients taking low-dose aspirin, which is reassuring because other research has shown that low-dose aspirin negates any benefit of celecoxib.
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PRACTICE RECOMMENDATIONS

Among arthritis patients with a recent history of bleeding ulcer, celecoxib was just as likely as diclofenac plus omeprazole to cause recurrent bleeding. The effectiveness of these two regimens in preventing recurrent bleeding compared with a general nonsteroidal antiinflammatory drug (NSAID) used alone cannot be determined from this study. Unfortunately, adverse renal effects were common with both regimens.

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