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

Aliment Pharmacol Ther. 2008 May;27(9):838-45. doi: 10.1111/j.1365-2036.2008.03622.x. Epub 2008 Jan 22.


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.

Aim: 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.

Conclusion: Even with short-term use, there are gastrointestinal safety benefits for lumiracoxib vs. nonselective nonsteroidal anti-inflammatory drugs.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Arthritis / drug therapy*
  • Aspirin / adverse effects
  • Cyclooxygenase 2 Inhibitors / therapeutic use*
  • Diclofenac / adverse effects
  • Diclofenac / analogs & derivatives*
  • Female
  • Gastrointestinal Diseases / drug therapy*
  • Humans
  • Ibuprofen / adverse effects
  • Male
  • Middle Aged
  • Naproxen / adverse effects
  • Statistics as Topic


  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase 2 Inhibitors
  • Diclofenac
  • Naproxen
  • Aspirin
  • lumiracoxib
  • Ibuprofen