title: Efficacy of celecoxib versus ibuprofen for the treatment of patients with osteoarthritis of the knee: A randomized double-blind, non-inferiority trial.
abstract: Objective To compare the efficacy and tolerability of celecoxib and ibuprofen for the treatment of knee osteoarthritis symptoms. Method In this 6-week, multicentre, double-blind, non-inferiority trial, patients were randomized to 200 mg celecoxib once daily, 800 mg ibuprofen three times daily or placebo. The primary outcome was non-inferiority of celecoxib to ibuprofen in Patient's Assessment of Arthritis Pain (scored 0-100). Secondary outcomes included the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, Pain Satisfaction Scale, and upper gastrointestinal tolerability. Results A total of 388 patients were treated (celecoxib n = 153; ibuprofen n = 156; placebo n = 79). Mean difference (95% confidence interval) between celecoxib and ibuprofen in the Patient's Assessment of Arthritis Pain was 2.76 (-3.38, 8.90). As the lower bound was greater than -10, celecoxib was non-inferior to ibuprofen. The WOMAC total score was significantly improved with celecoxib and ibuprofen, versus placebo. Patients receiving celecoxib were significantly more satisfied (versus placebo) in 10 of 11 measures on the Pain Satisfaction Scale versus three measures with ibuprofen. Upper gastrointestinal events were less frequent with celecoxib (1.3%) than ibuprofen (5.1%) or placebo (2.5%). Conclusion Celecoxib was well tolerated and as effective as ibuprofen for symptoms associated with knee osteoarthritis. ClinicalTrials.gov identifier NCT00630929.
authors.affiliation: 1 Pfizer Ltd, Porto Salvo, Portugal.
authors.forename: Ana C
authors.initials: AC
authors.lastname: Gordo
authors.affiliation: 2 Pfizer Inc., Walton Oaks, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Walker
authors.affiliation: 3 Medical Department, Pfizer SLU, Alcobendas, Madrid, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Armada
authors.affiliation: 4 Pfizer Inc., New York, NY, USA.
authors.forename: Duo
authors.initials: D
authors.lastname: Zhou
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018712:Analgesics, Non-Narcotic / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D000068579:Celecoxib / Q000627:therapeutic use*; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D007719:Knee Joint / Q000187:drug effects / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D010919:Placebos; D000068579:Celecoxib; D007052:Ibuprofen
keywords: COX-2 inhibitors; celecoxib; cyclooxygenase; non-steroidal anti-inflammatory drugs; osteoarthritis