Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: A twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout
Autor: | Patricia A. MacDonald, William A. Palo, Robert L. Wortmann, Laurent Vernillet, H. Ralph Schumacher, Nancy Joseph-Ridge, Denise Eustace, Michael Becker |
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Rok vydání: | 2005 |
Předmět: |
Adult
Male Xanthine Oxidase medicine.medical_specialty Randomization Gout Dose Immunology Hyperuricemia Placebo Gastroenterology chemistry.chemical_compound Febuxostat Double-Blind Method Rheumatology Internal medicine medicine Humans Immunology and Allergy Pharmacology (medical) Enzyme Inhibitors Adverse effect Dose-Response Relationship Drug business.industry Middle Aged medicine.disease Uric Acid Surgery Thiazoles Treatment Outcome chemistry Uric acid Female business medicine.drug |
Zdroj: | Arthritis & Rheumatism. 52:916-923 |
ISSN: | 1529-0131 0004-3591 |
DOI: | 10.1002/art.20935 |
Popis: | Objective Gout affects ∼1–2% of the American population. Current options for treating hyperuricemia in chronic gout are limited. The purpose of this study was to assess the safety and efficacy of febuxostat, a nonpurine selective inhibitor of xanthine oxidase, in establishing normal serum urate (sUA) concentrations in gout patients with hyperuricemia (≥8.0 mg/dl). Methods We conducted a phase II, randomized, double-blind, placebo-controlled trial in 153 patients (ages 23–80 years). Subjects received febuxostat (40 mg, 80 mg, 120 mg) or placebo once daily for 28 days and colchicine prophylaxis for 14 days prior to and 14 days after randomization. The primary end point was the proportion of subjects with sUA levels |
Databáze: | OpenAIRE |
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