title: Etoricoxib versus indometacin in the treatment of Chinese patients with acute gouty arthritis: a randomized double-blind trial.
abstract: BACKGROUND
  Acute gout is an intensely painful, inflammatory arthritis. Although the non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for this condition, the efficacy is based on only a few studies, particularly in China. We tried to assess the safety and efficacy of etoricoxib in the treatment of acute gouty arthritis in China.
  
  
  METHODS
  A randomized, double-blind, active comparator study was conducted at 10 sites in China. Patients (n = 178; ≥ 18 years of age) with acute gouty attack (< 48 hours) were treated for 5 days with etoricoxib (120 mg/d; n = 89) or indometacin (75 mg twice daily; n = 89). The primary efficacy end point was self-assessed pain in the affected joint (0-4 point Likert scale) from days 2 - 5. Secondary end points included investigator assessments of tenderness and swelling, patient/ investigator global assessments of response to therapy, and patients discontinuing treatment. Safety was assessed by adverse events (AEs).
  
  
  RESULTS
  Etoricoxib and indometacin had comparable primary and secondary end points. Mean change difference from baseline from days 2 - 5 was 0.03 (95% confidence interval (CI) -0.19 to 0.25; P = 0.6364), which fell within the prespecified comparative bounds of -0.5 to 0.5. No severe AEs were associated with etoricoxib use. Non-severe AEs were mainly digestive and general, and most (73.7%) were mild, although they caused withdrawal of two subjects in the etoricoxib group, due to bilateral renal calculi and uronephrosis of the left kidney (unrelated to etoricoxib) and fever and chills (potentially etoricoxib-related). Overall, AEs were similar, although the absolute number of AEs in the etoricoxib group (n = 31) was less than the indometacin group (n = 34).
  
  
  CONCLUSIONS
  Etoricoxib (120 mg once daily) is effective in treating acute gout, is generally safe and well-tolerated, and is comparable in efficacy to indometacin (75 mg twice daily).
authors.affiliation: Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200001, China.
authors.forename: Ting
authors.initials: T
authors.lastname: Li
authors.forename: Shun-le
authors.initials: SL
authors.lastname: Chen
authors.forename: Qing
authors.initials: Q
authors.lastname: Dai
authors.forename: Xing-Hai
authors.initials: XH
authors.lastname: Han
authors.forename: Zhan-Guo
authors.initials: ZG
authors.lastname: Li
authors.forename: Dong-Hai
authors.initials: DH
authors.lastname: Wu
authors.forename: Xiao
authors.initials: X
authors.lastname: Zhang
authors.forename: Jie-Ruo
authors.initials: JR
authors.lastname: Gu
authors.forename: Nan-Ping
authors.initials: NP
authors.lastname: Yang
authors.forename: Ling-Yun
authors.initials: LY
authors.lastname: Sun
authors.forename: Miu-Jia
authors.initials: MJ
authors.lastname: Zhang
authors.forename: Xing-Fu
authors.initials: XF
authors.lastname: Li
authors.forename: Chun-de
authors.initials: CD
authors.lastname: Bao
mesh_terms: D000328:Adult; D000368:Aged; D015210:Arthritis, Gouty / Q000188:drug therapy*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D016861:Cyclooxygenase Inhibitors; D011725:Pyridines; D013450:Sulfones; D000077613:Etoricoxib; D007213:Indomethacin