title: Efficacy and tolerability of lumiracoxib 100 mg once daily in knee osteoarthritis: a 13-week, randomized, double-blind study vs. placebo and celecoxib.
abstract: OBJECTIVE
  To determine the efficacy and safety of lumiracoxib for knee osteoarthritis (OA).
  
  
  METHODS
  This was a 13-week, multicentre, randomized, double-blind, double-dummy, placebo-controlled study. Males or females aged >/= 18 years with primary knee OA received lumiracoxib 100 mg od, lumiracoxib 100 mg od with a loading dose of 200 mg od for the first two weeks, celecoxib 200 mg od, or placebo.
  
  
  METHODS
  Co-primary variables, assessed at week 13, were OA pain intensity in the target knee, patient's global assessment of disease activity and the WOMAC total score. Other variables included OMERACT-OARSI responder rates and WOMAC subscale scores. Safety and tolerability were evaluated.
  
  
  RESULTS
  All active treatments were superior to placebo for all co-primary variables. No significant differences were observed between any active treatments. Mean reductions from baseline to week 13 for lumiracoxib 100mg od, 100mg od with loading dose, celecoxib and placebo, respectively, were: OA pain intensity in the target knee: 26.8, 26.2, 26.6 and 21.4mm (all p < 0.01 vs. placebo); patient's global assessment of disease activity: 25.1, 21.9, 22.9 and 18.9 mm (all p < 0.05 vs. placebo); WOMAC total score: 15.2, 14.8, 14.7 and 11.3 (all p < 0.01 vs. placebo). Lumiracoxib was superior to placebo and similar to celecoxib for OMERACT-OARSI response and WOMAC subscale scores. Lumiracoxib was well tolerated. The incidence of adverse events was similar across groups.
  
  
  CONCLUSIONS
  Lumiracoxib 100 mg od provided effective relief from the pain of knee OA, with efficacy similar to celecoxib 200 mg od, and was well tolerated.
authors.affiliation: Klinische Forschung Berlin Buch, Berlin, Germany.
authors.forename: Reiner
authors.initials: R
authors.lastname: Lehmann
authors.forename: Marek
authors.initials: M
authors.lastname: Brzosko
authors.forename: Petr
authors.initials: P
authors.lastname: Kopsa
authors.forename: Ruth
authors.initials: R
authors.lastname: Nischik
authors.forename: Andreas
authors.initials: A
authors.lastname: Kreisse
authors.forename: Helen
authors.initials: H
authors.lastname: Thurston
authors.forename: Stephane
authors.initials: S
authors.lastname: Litschig
authors.forename: Victor S
authors.initials: VS
authors.lastname: Sloan
mesh_terms: D000203:Activities of Daily Living; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D004008:Diclofenac / Q000031:analogs & derivatives; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009930:Organic Chemicals / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010919:Placebos; D011720:Pyrazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D016861:Cyclooxygenase Inhibitors; D009930:Organic Chemicals; D010919:Placebos; D011720:Pyrazoles; D013449:Sulfonamides; D004008:Diclofenac; D000068579:Celecoxib; C473384:lumiracoxib