Abstract | BACKGROUND:
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.
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Authors | C J Hawkey, M Farkouh, X Gitton, E Ehrsam, J Huels, P Richardson |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 20
Issue 1
Pg. 51-63
(Jul 01 2004)
ISSN: 0269-2813 [Print] England |
PMID | 15225171
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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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
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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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