A phase 3, multicenter, randomized, allopurinol‐controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia. (27th May 2015)

• Record Type: Journal Article
• Authors: Xu, Shaoyong; Liu, Xiangyang; Ming, Jie; Chen, Shenren; Wang, Yangang; Liu, Xiumei; Liu, Hong; Peng, Yongde; Wang, Jianqin; Lin, Jinying; Ji, Haiwang; Liu, Bin; Lu, Ying; Liu, Peng; Zhang, Yonghong; Ji, Qiuhe
• Is Part Of: International journal of rheumatic diseases. Volume 18:Number 6(2015)
• Page Start: 669
• Page End: 678
• Publication Date: 2015-05-27
• Subjects: allopurinol -- febuxostat -- gout -- hyperuricemia; Rheumatology -- Periodicals; Rheumatology -- Asia -- Periodicals; Rheumatology -- Pacific Area -- Periodicals; Rheumatic Diseases -- Periodicals; Connective Tissue Diseases -- Periodicals; Immune System Diseases -- Periodicals; 616.723
• DOI: 10.1111/1756-185X.12648
• Languages: English
• ISSNs: 1756-1841

Abstract

Abstract: Aim: To compare the efficiency and safety of febuxostat with those of allopurinol in Chinese patients with gout and hyperuricemia. Methods: The trial which was conducted at 13 centers in China during 2011–2013 included a 2‐week run‐in and a 24‐week treatment period. A total of 504 eligible participants with gout and with serum urate ≥ 480 μmol/L were randomly assigned 1 : 1 : 1 to febuxostat 40 mg/day, febuxostat 80 mg/day and allopurinol 300 mg/day groups. The primary efficacy endpoint was the percentage of subjects whose last three serum urate levels were < 360 μmol/L. Results: The primary efficacy endpoint was reached by 33.5% of subjects taking febuxostat 80 mg/day, 22.5% of those taking febuxostat 40 mg/day and 17.0% of those taking allopurinol 300 mg/day ( P < 0.001 for the comparison between febuxostat 80 mg/day and allopurinol 300 mg/day groups; P = 0.216 for the comparison between febuxostat 40 mg/day and allopurinol 300 mg/day groups). The incidence of gout flare was relatively high in each group during the first 8 weeks and gradually decreased thereafter. There was no statistically significant difference between the three groups ( P > 0.05). The incidence of adverse events was similar in the three treatment groups. The most frequent treatment‐related adverse events were liver function test abnormalities. Conclusions: Febuxostat 80 mg/day had superior urate‐lowering efficacy to that of febuxostat 40 mg/day or allopurinol 300 mg/day, which was comparable in Chinese gout patients with hyperuricemia. Febuxostat, at a daily dose of 40 or 80 mg, was safe and well tolerated.