6/28/23, 12:26 AM Celecoxib vs. diclofenac in arthritis with recent ulcer bleeding Pathway Feedback Search Clinical Topics Home Studies Celecoxib vs. diclofenac in arthritis with recent ulcer bleeding Celecoxib vs. diclofenac in arthritis with recent ulcer bleeding Disease Disease Disease Ankylosing spondylitis Chronic arthritic pain Hand o Trial question What is the role of celecoxib in patients with arthritis and a recent history of ulcer bleeding? Study design Single center Double blinded RCT Population Characteristics of study participants 56.0% female N = 287 44.0% male 287 patients (161 female, 126 male) Inclusion criteria: patients with arthritis and a recent history of ulcer bleeding Key exclusion criteria: concomitant use of anticoagulant agents or corticosteroids; a history of gastric or duodenal surgery other than a patch repair; and the presence of erosive esophagitis, gastric outlet obstruction, renal failure, terminal illness, or cancer Interventions N=144 celecoxib (200 mg BID plus omeprazole placebo daily for 6 months) N=143 diclofenac plus omeprazole (75 mg ER diclofenac BID plus 20 mg of omeprazole daily for 6 months) Primary outcome Rate of probability of recurrent bleeding during the 6-month period 6.4 6.4 % 4 9 https://web.pathway.md/studies/recRrSVOg3pwWuJYE 1/2 6/28/23, 12:26 AM Celecoxib vs. diclofenac in arthritis with recent ulcer bleeding Pathway 4.9 4.8 % 3.2 % Difference not exceeding nonferiority margin 1.6 % 0.0 % Celecoxib Diclofenac plus omeprazole Difference not exceeding nonferiority margin in the rate of probability of recurrent bleeding during the 6-month period (4.9% vs. 6.4%; AD -1.5%, 95% CI -6.8 to 3.8) Safety outcomes Significant differences in renal adverse events, including hypertension, peripheral edema, and renal failure (24.3% vs. 30.8%). Conclusion In patients with arthritis and a recent history of ulcer bleeding, celecoxib was noninferior to diclofenac plus omeprazole with respect to the rate of probability of recurrent bleeding during the 6-month period. Reference Chan FK, Hung LC, Suen BY et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med. 2002 Dec 26;347(26):2104-10. Open reference URL https://web.pathway.md/studies/recRrSVOg3pwWuJYE 2/2