title: Gastroduodenal safety and tolerability of lumiracoxib compared with Ibuprofen and celecoxib in patients with osteoarthritis.
abstract: OBJECTIVE
  To compare the incidence of gastroduodenal ulcers in patients with osteoarthritis (OA) treated with therapeutic doses of the novel COX-2 selective inhibitor, lumiracoxib (COX189, Prexige), and the standard nonsteroidal antiinflammatory drug (NSAID) ibuprofen. The COX-2 selective inhibitor celecoxib was included as an active control.
  
  
  METHODS
  In this randomized, multicenter, double-blind, parallel-group study, eligible patients were randomized to receive lumiracoxib 200 mg (n = 264) or 400 mg (n = 260) once daily (qd), ibuprofen 800 mg (n = 260) 3 times daily (tid), or celecoxib 200 mg qd (n = 258) for 13 weeks. The incidence of gastroduodenal ulcers and erosions was determined by endoscopy prior to randomization, and after 4 weeks and 13 weeks of treatment (end of study). Frequencies of adverse events were also recorded.
  
  
  RESULTS
  The cumulative incidence of gastroduodenal ulcers >/= 3 mm in diameter was significantly lower in the lumiracoxib groups (200 mg: 4.3%; 400 mg: 4.0%) than in the ibuprofen group (15.7%; p < 0.001) and similar to the celecoxib group (3.2%). In the ibuprofen group, a significantly greater number of patients (6.0%) had > 10 gastroduodenal erosions compared with lumiracoxib 200 mg (1.2%; p < 0.01), lumiracoxib 400 mg (1.6%; p < 0.05), and celecoxib (2.4%; p < 0.05). A greater number of patients in the ibuprofen group discontinued treatment due to an adverse event compared with both lumiracoxib groups and the celecoxib group.
  
  
  CONCLUSIONS
  In patients with OA, lumiracoxib 200 mg or 400 mg qd was associated with a significantly lower risk of gastroduodenal ulceration than ibuprofen 800 mg tid, and was similar to celecoxib 200 mg qd.
authors.affiliation: University Hospital Nottingham, Nottingham, United Kingdom. cj.hawkey@nottingham.ac.uk
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Hawkey
authors.forename: Petr
authors.initials: P
authors.lastname: Svoboda
authors.forename: Irena F
authors.initials: IF
authors.lastname: Fiedorowicz-Fabrycy
authors.forename: Evgeny L
authors.initials: EL
authors.lastname: Nasonov
authors.forename: Eduard G
authors.initials: EG
authors.lastname: Pikhlak
authors.forename: Marc
authors.initials: M
authors.lastname: Cousin
authors.forename: Xavier
authors.initials: X
authors.lastname: Gitton
authors.forename: Godehard
authors.initials: G
authors.lastname: Hoexter
mesh_terms: D000368:Aged; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D004008:Diclofenac / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009930:Organic Chemicals / Q000008:administration & dosage / Q000009:adverse effects*; D010003:Osteoarthritis / Q000188:drug therapy* / Q000453:epidemiology; D010437:Peptic Ulcer / Q000139:chemically induced* / Q000453:epidemiology; D011720:Pyrazoles; D012307:Risk Factors; D013449:Sulfonamides / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: D016861:Cyclooxygenase Inhibitors; D009930:Organic Chemicals; D011720:Pyrazoles; D013449:Sulfonamides; D004008:Diclofenac; D000068579:Celecoxib; C473384:lumiracoxib; D007052:Ibuprofen