Celecoxib vs. diclofenac in arthritis with recent ulcer bleeding
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
44.0% male
N = 287
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 extended-release diclofenac BID plus 20 mg of omeprazole daily for 6 months).
Primary outcome
Rate of probability of recurrent bleeding during the 6-month period
4.9%
6.4%
6.4 %
4.8 %
3.2 %
1.6 %
0.0 %
Celecoxib
Diclofenac plus
omeprazole
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority 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.
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