Efficacy and Tolerability of Celecoxib in the Treatment of Acute Gouty Arthritis: A Randomized Controlled Trial

Objective. To evaluate the analgesic efficacy of high-dose celecoxib in the treatment of moderate to extreme pain and inflammation associated with acute gouty arthritis. Methods. A multinational, randomized, double-blind, double-dummy, active-controlled trial was done with patients (aged >= 18 years) with acute gouty monoarthritis or oligoarthritis (onset of pain <= 48 h before enrollment). Patients were treated for 8 days with 1 week followup and were randomized 1:1:1:1 to receive celecoxib 50 mg bid, celecoxib 400 mg (followed by 200 mg later on Day 1 and then 200 mg bid for 7 days), celecoxib 800 mg (followed by 400 mg later on Day 1 and then 400 mg bid for 7 days), or indomethacin 50 mg tid. Results. Of 443 patients screened, 402 were randomized and 400 received treatment. Baseline demo-graphics were comparable among treatments. Patients receiving high-dose celecoxib (800/400 mg) experienced a significantly greater reduction in pain intensity on Day 2 compared with low-dose celecoxib 50 mg bid [least squares (LS) mean difference -0.46; p = 0.00141. For high-dose celecoxib 800/400 mg, the change in pain scores from baseline to Day 2 was comparable with indomethacin 50 mg tid (LS mean difference 0.11; p = 0.4331). There were significant differences in adverse events when the combined celecoxib groups (29.5%) were compared with patients taking indomethacin (43.1%; p = 0.0116). There was no change in median serum creatinine levels for any treatment. There were more discontinuations due to adverse events (8.8% vs 3%; p = 0.0147) with indomethacin than with the combined celecoxib groups. Conclusion. High-dose celecoxib (800/400 mg) was significantly more effective than low-dose celecoxib (50 mg bid) and comparable to indomethacin in the treatment of moderate to extreme pain in patients with acute gouty arthritis. Further, celecoxib was well tolerated. (First Release Aug 1 2012; J Rheumatol 2012;39:1859-66: doi: 10.3899/jrheum.110916)