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

Alimentary Pharmacology & Therapeutics
Christopher J HawkeyP Richardson

Abstract

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. 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. 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 mea...Continue Reading

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Citations

Jan 6, 2006·The Journal of Clinical Investigation·Tilo GrosserGarret A FitzGerald
Jul 6, 2007·BMC Gastroenterology·Michael LoydPhilip Jacobs
Oct 1, 2004·Drugs·Katherine A Lyseng-Williamson, Monique P Curran
Jul 26, 2006·Expert Opinion on Drug Metabolism & Toxicology·Mansoor AhmedDaniel E Furst
Aug 24, 2005·International Journal of Clinical Practice·D J Dickson
Sep 6, 2008·The Journal of Clinical Hypertension·Michael E FarkouhJames H Chesebro
May 1, 2005·Expert Review of Clinical Immunology·Raban V JegerMichael E Farkouh
Jan 18, 2005·The Journal of International Medical Research·F BerenbaumV S Sloan
Oct 11, 2019·Statistical Methods in Medical Research·Olivier CollignonRiccardo Spezia

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