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Therapeutic arthritis research and gastrointestinal event trial of lumiracoxib - study design and patient demographics.

AbstractBACKGROUND:
Cyclooxygenase-2 selective inhibitors were developed in order to reduce the incidence of life-threatening gastrointestinal ulcer complications compared with non-selective non-steroidal anti-inflammatory drugs. Previous outcomes studies have, variously, lacked power to investigate this endpoint, focused on broader outcomes, or been too small to quantify the influence of aspirin.
AIM:
To evaluate lumiracoxib, a novel cyclooxygenase-2 selective inhibitor, vs. non-selective non-steroidal anti-inflammatory drugs in an outcomes study of considerably increased size. This paper describes the study's methodology.
METHODS AND PATIENTS:
The Therapeutic Arthritis Research and Gastrointestinal Event Trial was a randomized, double-blind, 52-week study of lumiracoxib 400 mg once daily (two to four times the recommended dose for osteoarthritis) versus naproxen 500 mg twice daily or ibuprofen 800 mg three-times daily in patients with osteoarthritis. Randomization was stratified for low-dose aspirin use and age (< or = 64, 65-74, > or= 75 years). The study was powered to investigate upper gastrointestinal ulcer complications (primary endpoint) in patients not taking aspirin and in the overall study population; other endpoints included cardiovascular, renal and hepatic measures.
CONCLUSIONS:
Therapeutic Arthritis Research and Gastrointestinal Event Trial was designed to provide definitive answers concerning the gastrointestinal safety of lumiracoxib, addressing the controversial issues arising from outcomes studies with other cyclooxygenase-2 selective inhibitors.
AuthorsC J Hawkey, M Farkouh, X Gitton, E Ehrsam, J Huels, P Richardson
JournalAlimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 20 Issue 1 Pg. 51-63 (Jul 01 2004) ISSN: 0269-2813 [Print] England
PMID15225171 (Publication Type: Clinical Trial, 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
  • Cyclooxygenase Inhibitors
  • Isoenzymes
  • Membrane Proteins
  • Organic Chemicals
  • Diclofenac
  • Naproxen
  • Cyclooxygenase 2
  • PTGS2 protein, human
  • Prostaglandin-Endoperoxide Synthases
  • Aspirin
  • lumiracoxib
  • Ibuprofen
Topics
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
  • Aspirin (administration & dosage, adverse effects)
  • Cyclooxygenase 2
  • Cyclooxygenase 2 Inhibitors
  • Cyclooxygenase Inhibitors (administration & dosage, adverse effects)
  • Diclofenac (analogs & derivatives)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Health Status
  • Humans
  • Ibuprofen (administration & dosage, adverse effects)
  • Isoenzymes (antagonists & inhibitors)
  • Membrane Proteins
  • Middle Aged
  • Naproxen (administration & dosage, adverse effects)
  • Organic Chemicals (administration & dosage, adverse effects)
  • Osteoarthritis (drug therapy)
  • Peptic Ulcer (chemically induced)
  • Prognosis
  • Prostaglandin-Endoperoxide Synthases
  • Risk Factors

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