title: Clinical trial: comparison of the gastrointestinal safety of lumiracoxib with traditional nonselective nonsteroidal anti-inflammatory drugs early after the initiation of treatment--findings from the Therapeutic Arthritis Research and Gastrointestinal Event Trial.
abstract: BACKGROUND
  The large (n = 18 325) Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) study demonstrated a significant gastrointestinal benefit with lumiracoxib 400 mg o.d. (4x the recommended dose in osteoarthritis) vs. naproxen 500 mg b.d. or ibuprofen 800 mg t.d.s.
  
  
  OBJECTIVE
  To investigate how early a reduction in ulcer complications could be detected with lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs in TARGET.
  
  
  METHODS
  Pointwise 95% confidence intervals were generated for the between-treatment differences in Kaplan-Meier estimates for definite or probable upper gastrointestinal ulcer complications (ulcer complications) and for all ulcers.
  
  
  RESULTS
  In patients not on aspirin, there was a significant reduction in all ulcers by day 8 and in ulcer complications by day 16 with lumiracoxib compared with both nonselective nonsteroidal anti-inflammatory drugs combined, by day 6 (all ulcers) and day 14 (ulcer complications) vs. naproxen and by day 32 (all ulcers) and day 33 (ulcer complications) vs. ibuprofen.
  
  
  CONCLUSIONS
  Even with short-term use, there are gastrointestinal safety benefits for lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs.
authors.affiliation: Wolfson Digestive Diseases Centre, University Hospital Nottingham, Nottingham, UK. cj.hawkey@nottingham.ac.uk
authors.forename: C J
authors.initials: CJ
authors.lastname: Hawkey
authors.forename: W M
authors.initials: WM
authors.lastname: Weinstein
authors.forename: K
authors.initials: K
authors.lastname: Stricker
authors.forename: V
authors.initials: V
authors.lastname: Murphy
authors.forename: D
authors.initials: D
authors.lastname: Richard
authors.forename: G
authors.initials: G
authors.lastname: Krammer
authors.forename: R
authors.initials: R
authors.lastname: Rebuli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001168:Arthritis / Q000188:drug therapy*; D001241:Aspirin / Q000009:adverse effects; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004008:Diclofenac / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy*; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects; D013223:Statistics as Topic
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D004008:Diclofenac; D009288:Naproxen; D001241:Aspirin; C473384:lumiracoxib; D007052:Ibuprofen