title: Efficacy and tolerability profile of etoricoxib in patients with osteoarthritis: A randomized, double-blind, placebo and active-comparator controlled 12-week efficacy trial.
abstract: OBJECTIVE
  To evaluate the efficacy of 12 weeks of treatment with etoricoxib, a selective COX-2 inhibitor, in patients with osteoarthritis (OA) of the knee or hip.
  
  
  METHODS
  In the 12-week placebo- and active comparator-controlled period of a randomized, double-blind study, eligible patients were treated with etoricoxib 60 mg once daily (n = 224), naproxen 500 mg twice daily (n = 221), or placebo (n = 56). Western Ontario McMaster's Osteoarthritis Index (WOMAC) pain and physical function subscales and patient's global assessment of disease status were primary end points. Key secondary and other end points were patient's and investigator's global assessment of response to therapy, WOMAC stiffness subscale, investigator's global assessment of disease status, rescue paracetamol use, proportion of patients discontinuing due to lack of efficacy, and study joint tenderness.
  
  
  RESULTS
  Etoricoxib 60 mg demonstrated efficacy significantly superior to placebo (p < or = 0.005) and comparable to naproxen 500 mg twice daily as assessed by the primary efficacy end points. Secondary and other end points confirmed these results. Treatment effects were evident by day 2, maximal by week 2, and sustained over the entire 12 weeks. Etoricoxib was well tolerated for 12 weeks.
  
  
  CONCLUSIONS
  Etoricoxib showed rapid and durable treatment effects in patients with OA of the knee or hip. Etoricoxib was generally well tolerated.
authors.affiliation: Merck Research Laboratories, Rahway, New Jersey 07065, USA.
authors.forename: Albert T
authors.initials: AT
authors.lastname: Leung
authors.forename: Kerstin
authors.initials: K
authors.lastname: Malmstrom
authors.forename: Alberto E
authors.initials: AE
authors.lastname: Gallacher
authors.forename: Brian
authors.initials: B
authors.lastname: Sarembock
authors.forename: Gyula
authors.initials: G
authors.lastname: Poor
authors.forename: Andre
authors.initials: A
authors.lastname: Beaulieu
authors.forename: Ricardo
authors.initials: R
authors.lastname: Castro
authors.forename: Matilde
authors.initials: M
authors.lastname: Sanchez
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Detora
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ng
mesh_terms: D051546:Cyclooxygenase 2; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D000077613:Etoricoxib; D005260:Female; D006801:Humans; D007527:Isoenzymes / Q000037:antagonists & inhibitors*; D008297:Male; D008565:Membrane Proteins; D008875:Middle Aged; D009288:Naproxen / Q000627:therapeutic use; D015207:Osteoarthritis, Hip / Q000188:drug therapy*; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D011451:Prostaglandin-Endoperoxide Synthases; D011725:Pyridines / Q000627:therapeutic use*; D012449:Safety; D013450:Sulfones / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007527:Isoenzymes; D008565:Membrane Proteins; D011725:Pyridines; D013450:Sulfones; D009288:Naproxen; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases; D000077613:Etoricoxib