title: Efficacy and tolerability of celecoxib in the treatment of acute gouty arthritis: a randomized controlled trial.
abstract: 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 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Pennsylvania, VA Medical Center, 151K, University and Woodland Aves., Philadelphia, PA 19104, USA. schumacr@mail.med.upenn.edu
authors.forename: H Ralph
authors.initials: HR
authors.lastname: Schumacher
authors.forename: Manuela F
authors.initials: MF
authors.lastname: Berger
authors.forename: Julie
authors.initials: J
authors.lastname: Li-Yu
authors.forename: Fernando
authors.initials: F
authors.lastname: Perez-Ruiz
authors.forename: Rubén
authors.initials: R
authors.lastname: Burgos-Vargas
authors.forename: Chunming
authors.initials: C
authors.lastname: Li
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015210:Arthritis, Gouty / Q000188:drug therapy*; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib