title: A randomized trial of the efficacy and tolerability of the COX-2 inhibitor rofecoxib vs ibuprofen in patients with osteoarthritis. Rofecoxib/Ibuprofen Comparator Study Group.
abstract: BACKGROUND
  Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). It is not known whether a specific inhibitor of COX-2 will provide efficacy in osteoarthritis (OA) comparable with NSAIDs. Therefore, we compared the efficacy and safety of the rofecoxib, which specifically inhibits COX-2, with those of the NSAID ibuprofen in patients with OA.
  
  
  OBJECTIVE
  To compare the clinical efficacy and tolerability of rofecoxib (12.5 and 25 mg once daily) with ibuprofen (800 mg 3 times daily).
  
  
  METHODS
  A randomized, double-blind trial of 809 adults with OA was conducted. Patients with OA in whom the knee or hip was the primary source of pain were randomized to 1 of 4 treatment groups on demonstration of disease activity: placebo; rofecoxib, 12.5 or 25 mg once daily; or ibuprofen, 800 mg 3 times daily. Clinical efficacy and safety were monitored during a 6-week treatment period.
  
  
  RESULTS
  Both doses of rofecoxib demonstrated efficacy clinically comparable with ibuprofen as assessed by 3 primary end points (pain walking on a flat surface [Western Ontario and McMaster Universities Osteoarthritis Index], patient global assessment of response to therapy, and investigator global assessment of disease status) according to predefined comparability criteria. Both rofecoxib doses and the ibuprofen dose provided significantly (P<.001) greater efficacy than placebo on all primary end points. Results from secondary end points were consistent with those of the primary end points. All treatments were well tolerated; the overall incidence rates of clinical adverse experiences were not significantly different (P>.05) among the treatment groups.
  
  
  CONCLUSIONS
  Rofecoxib was well tolerated and provided clinical efficacy comparable with a high dose of the NSAID ibuprofen.
authors.affiliation: St Vincent's Hospital, Darlinghurst, Australia.
authors.forename: R
authors.initials: R
authors.lastname: Day
authors.forename: B
authors.initials: B
authors.lastname: Morrison
authors.forename: A
authors.initials: A
authors.lastname: Luza
authors.forename: O
authors.initials: O
authors.lastname: Castaneda
authors.forename: A
authors.initials: A
authors.lastname: Strusberg
authors.forename: M
authors.initials: M
authors.lastname: Nahir
authors.forename: K B
authors.initials: KB
authors.lastname: Helgetveit
authors.forename: B
authors.initials: B
authors.lastname: Kress
authors.forename: B
authors.initials: B
authors.lastname: Daniels
authors.forename: J
authors.initials: J
authors.lastname: Bolognese
authors.forename: D
authors.initials: D
authors.lastname: Krupa
authors.forename: B
authors.initials: B
authors.lastname: Seidenberg
authors.forename: E
authors.initials: E
authors.lastname: Ehrich
mesh_terms: D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects / Q000627:therapeutic use*; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D013450:Sulfones; D016896:Treatment Outcome
chemical_list: D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib; D007052:Ibuprofen