It is known that treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) can result in significant gastrointestinal complications. Patients with osteoarthritis are most commonly treated with either NSAIDs or cyclo-oxygenase 2 (COX2) inhibitors. Despite their efficacy, COX2 inhibitors have been the center of much concern regarding safety, mainly because of results indicating increased thromboembolic events; however, research into the gastrointestinal complications of celecoxib has not been conclusive.OBJECTIVE
The object of this study was to investigate and compare the gastrointestinal safety and overall efficacy of the COX2 inhibitor celecoxib with the NSAIDs naproxen and diclofenac in the treatment of patients with osteoarthritis.DESIGN AND INTERVENTION
This was a 12-week, randomized, double-blind, three-arm, controlled, active-comparator, multicenter trial. Patients over 18 years of age, who met the American College of Rheumatology criteria for osteoarthritis of the hand, hip or knee and who had a disease duration of >6 months prior to randomization, were included in this study. Exclusion criteria included a history of active peptic ulceration, gastrointestinal bleeding, or active gastrointestinal disease. Patients participating in this trial did not undergo a washout period before receiving either celecoxib, naproxen or diclofenac. Patients were allowed to take up to 325 mg aspirin daily. Safety and efficacy were assessed before treatment, at week 6, and at week 12. Analysis was by intention to treat.OUTCOME MEASURES
Improvements in efficacy and safety.RESULTS
A total of 13,274 patients were included in this study. Patients were randomly allocated to receive either 100 mg celecoxib (n=4,393), 200 mg celecoxib (n=4,407), 500 mg naproxen (n=905), or 50 mg diclofenac (n=3,489) twice daily for 12 weeks. Analyses showed no differences in efficacy for either of the celecoxib doses, compared with the NSAID groups in the treatment of osteoarthritis. The number of ulcer complications was significantly increased in the groups receiving NSAIDs (0.8/100 patient-years) compared with the two celecoxib groups (0.1/100 patient-years, odds ratio 7.02, 95% CI 1.46-33.80, P=0.008). This was regardless of aspirin use. Cardiovascular adverse events were few and did not differ statistically between groups.CONCLUSION
The authors conclude that celecoxib is as effective as naproxen and diclofenac in the treatment of osteoarthritis and has fewer serious gastrointestinal adverse events.