title: Etoricoxib in the treatment of Korean patients with osteoarthritis in a double-blind, randomized controlled trial.
abstract: OBJECTIVE
  We evaluated the COX-2 inhibitors, etoricoxib and celecoxib, in Korean patients with osteoarthritis (OA).
  
  
  METHODS
  This study included patients (≥ 40 years of age) with a clinical and radiographic diagnosis of knee OA. Patients were randomized to etoricoxib 30 mg (qd) or celecoxib 200 mg (qd) in a 12 week randomized, controlled, double-blind study. Prior NSAID users were to demonstrate a worsening of symptoms upon withdrawal of medication. Efficacy endpoints included the time-weighted average change from baseline in the WOMAC VA 3.0 Pain Subscale (100 mm Visual Analog Scale [VAS]; primary endpoint), the WOMAC VA 3.0 Physical Function Subscale (100 mm VAS), and Patient Global Assessment of Disease Status (PGAD) (100 mm VAS). The primary hypothesis was that etoricoxib 30 mg is non-inferior to celecoxib 200 mg as assessed by the primary endpoint (the non-inferiority margin was set at 10 mm VAS). Adverse events (AEs), laboratory parameters, and vital signs were monitored.
  
  
  RESULTS
  There were 239 patients (89.5% female; mean age: 63.3 years) randomized to etoricoxib 30 mg (n = 120) and celecoxib 200 mg (n = 119). The differences (etoricoxib vs celecoxib) in least square (LS) mean change (95% CI) for WOMAC Pain, WOMAC Physical Function, and PGAD were -1.63 mm (-5.37, 2.10), -1.32 mm (-4.88, 2.23), and -1.09 mm (-5.48, 3.30), respectively. Drug-related clinical AEs occurred in 6.7% (etoricoxib) and 2.5% (celecoxib) of patients. This study was limited because it was not designed or powered to adequately capture and evaluate rare AEs associated with NSAID treatment.
  
  
  CONCLUSIONS
  Etoricoxib 30 mg administered once daily in Korean patients with knee OA demonstrated non-inferior clinical efficacy to celecoxib 200 mg over 12 weeks of treatment as assessed by all primary and secondary outcomes. Etoricoxib 30 mg qd and celecoxib 200 mg qd were generally safe and well tolerated.
  
  
  BACKGROUND
  NCT01554163.
authors.affiliation: Kyung Hee University Hospital , Seoul , Republic of Korea.
authors.forename: Myung Chul
authors.initials: MC
authors.lastname: Yoo
authors.forename: Wan Hee
authors.initials: WH
authors.lastname: Yoo
authors.forename: Seung Baek
authors.initials: SB
authors.lastname: Kang
authors.forename: Yong-Wook
authors.initials: YW
authors.lastname: Park
authors.forename: Sung Soo
authors.initials: SS
authors.lastname: Kim
authors.forename: Kyoung Ho
authors.initials: KH
authors.lastname: Moon
authors.forename: Yeong Wook
authors.initials: YW
authors.lastname: Song
authors.forename: Byung Woo
authors.initials: BW
authors.lastname: Min
authors.forename: Yoon Je
authors.initials: YJ
authors.lastname: Cho
authors.forename: Seong-Hwan
authors.initials: SH
authors.lastname: Moon
authors.forename: Seong-Il
authors.initials: SI
authors.lastname: Bin
authors.forename: Han-Joo
authors.initials: HJ
authors.lastname: Baek
authors.forename: Seung Cheol
authors.initials: SC
authors.lastname: Shim
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Lee
authors.forename: Dae Hyun
authors.initials: DH
authors.lastname: Yoo
authors.forename: Anish
authors.initials: A
authors.lastname: Mehta
authors.forename: Aleksandar
authors.initials: A
authors.lastname: Skuban
authors.forename: Diane M
authors.initials: DM
authors.lastname: Cukrow
authors.forename: Kristel
authors.initials: K
authors.lastname: Vandormael
authors.forename: Li
authors.initials: L
authors.lastname: Yan
mesh_terms: D000328:Adult; D000368:Aged; D000068579:Celecoxib; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000208:ethnology; D010147:Pain Measurement; D011720:Pyrazoles / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D056910:Republic of Korea; D013449:Sulfonamides / Q000627:therapeutic use*; D013450:Sulfones / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D011725:Pyridines; D013449:Sulfonamides; D013450:Sulfones; D000068579:Celecoxib; D000077613:Etoricoxib
keywords: COX-2 inhibitor; Celecoxib; Etoricoxib; Korean patients; NSAIDs; Osteoarthritis