Abstract | OBJECTIVE: 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 demographics 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=0.0014]. 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:
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Authors | H Ralph Schumacher, Manuela F Berger, Julie Li-Yu, Fernando Perez-Ruiz, Rubén Burgos-Vargas, Chunming Li |
Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 39
Issue 9
Pg. 1859-66
(Sep 2012)
ISSN: 0315-162X [Print] Canada |
PMID | 22859357
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Cyclooxygenase 2 Inhibitors
- Pyrazoles
- Sulfonamides
- Celecoxib
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Arthritis, Gouty
(drug therapy)
- Celecoxib
- Cyclooxygenase 2 Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Humans
- Male
- Middle Aged
- Pain Measurement
- Pyrazoles
(administration & dosage, adverse effects, therapeutic use)
- Sulfonamides
(administration & dosage, adverse effects, therapeutic use)
- Treatment Outcome
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