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Effect of risk factors on complicated and uncomplicated ulcers in the TARGET lumiracoxib outcomes study.

AbstractBACKGROUND & AIMS:
Selective cyclooxygenase-2 inhibitors were developed to reduce the gastrointestinal risk associated with nonsteroidal anti-inflammatory drugs (NSAIDs). The Therapeutic Arthritis Research and Gastrointestinal Event Trial was the largest study to evaluate primarily the gastrointestinal safety outcomes of selective cyclooxygenase-2 inhibitors. Data from the Therapeutic Arthritis Research and Gastrointestinal Event Trial were used to identify risk factors and investigate the safety of lumiracoxib in subgroups.
METHODS:
Patients with osteoarthritis (age, >or=50 y) were randomized to receive lumiracoxib 400 mg once daily, naproxen 500 mg twice daily, or ibuprofen 800 mg 3 times daily for 12 months. Events were categorized by a blinded adjudication committee. The primary end point was all definite or probable ulcer complications.
RESULTS:
For patients taking NSAIDs, factors associated with an increased risk of ulcer complications were age 65 years or older (hazard ratio [HR], 2.30; 95% confidence interval [CI], 1.48-3.59), previous history of gastrointestinal bleed or ulcer (HR, 3.61; 95% CI, 1.86-7.00), non-Caucasian racial origin (HR, 2.10; 95% CI, 1.35-3.27), and male sex (HR, 1.70; 95% CI, 1.08-2.68). With lumiracoxib, significant risk factors were age 65 years or older (HR, 3.18; 95% CI, 1.40-7.20), male sex (HR, 2.60; 95% CI, 1.25-5.40), non-Caucasian racial origin (HR, 2.16; 95% CI, 1.02-4.59), and concomitant aspirin use (HR, 2.89; 95% CI, 1.40-5.97). Increased risks in patients age 65 years and older were increased further if other risk factors were present. Lumiracoxib maintained an advantage over NSAIDs across all subgroups except aspirin use.
CONCLUSIONS:
Lumiracoxib was associated with a reduced risk of ulcer complications compared with NSAIDs in all significant subgroups except aspirin users.
AuthorsChristopher J Hawkey, Wilfred M Weinstein, Walter Smalley, Xavier Gitton, Peter Sallstig, Kirstin Stricker, Gerhard Krammer, Bernhard Mellein, Dominik Richard, Patrice Matchaba
JournalGastroenterology (Gastroenterology) Vol. 133 Issue 1 Pg. 57-64 (Jul 2007) ISSN: 0016-5085 [Print] United States
PMID17631131 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase 2 Inhibitors
  • Diclofenac
  • Naproxen
  • lumiracoxib
  • Ibuprofen
Topics
  • Age Distribution
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal (adverse effects)
  • Cyclooxygenase 2 Inhibitors (administration & dosage, adverse effects)
  • Diclofenac (administration & dosage, adverse effects, analogs & derivatives)
  • Duodenal Ulcer (chemically induced, epidemiology, prevention & control)
  • Female
  • Humans
  • Ibuprofen (adverse effects)
  • Male
  • Middle Aged
  • Naproxen (adverse effects)
  • Osteoarthritis (drug therapy)
  • Risk Factors
  • Risk Reduction Behavior
  • Stomach Ulcer (chemically induced, epidemiology, prevention & control)

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