An allopurinol-controlled, multicenter, randomized, double-blind, parallel between-group, comparative study of febuxostat in Chinese patients with gout and hyperuricemia

• Published in: International journal of rheumatic diseases 2014-07, Vol.17 (6), p.679-686
• Main Authors: Huang, Xinfang, Du, Hui, Gu, Jieruo, Zhao, Dongbao, Jiang, Lindi, Li, Xinfu, Zuo, Xiaoxia, Liu, Yi, Li, Zhanguo, Li, Xiangpei, Zhu, Ping, Li, Juan, Zhang, Zhiyi, Huang, Anbin, Zhang, Yuanchao, Bao, Chunde
• Format: Article
• Language: English
• Subjects: Adult; allopurinol; Allopurinol - adverse effects; Allopurinol - therapeutic use; Biomarkers - blood; China; Double-Blind Method; Enzyme Inhibitors - adverse effects; Enzyme Inhibitors - therapeutic use; Febuxostat; Female; gout; Gout - blood; Gout - diagnosis; Gout - drug therapy; Gout - enzymology; Gout Suppressants - adverse effects; Gout Suppressants - therapeutic use; Humans; hyperuricemia; Hyperuricemia - blood; Hyperuricemia - diagnosis; Hyperuricemia - drug therapy; Hyperuricemia - enzymology; Male; Middle Aged; Remission Induction; Thiazoles - adverse effects; Thiazoles - therapeutic use; Time Factors; Treatment Outcome; Uric Acid - blood; Xanthine Oxidase - antagonists & inhibitors; Xanthine Oxidase - metabolism
• ISSN: 1756-1841; 1756-185X
• DOI: 10.1111/1756-185X.12266

Aim Febuxostat, a novel non‐purine selective inhibitor of xanthine oxidase, has been identified as a potential alternative to allopurinol in patients with hyperuricemia. The purpose of this study was to compare the urate‐lowering (UL) efficacy and safety of daily febuxostat and allopurinol in Chinese gout patients with hyperuricemia. Methods Gout patients (n = 512) with serum uric acid (sUA) concentrations of at least 8.0 mg/dL were randomized to receive daily febuxostat 40 mg or 80 mg or allopurinol 300 mg for 28 weeks. Prophylaxis against gout flares with meloxicam or colchicine was provided during weeks 1 through 8. The primary endpoint was the percentage of subjects achieving a sUA concentration of