Premium
An allopurinol‐controlled, multicenter, randomized, double‐blind, parallel between‐group, comparative study of febuxostat in C hinese patients with gout and hyperuricemia
Author(s) -
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
Publication year - 2014
Publication title -
international journal of rheumatic diseases
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.795
H-Index - 41
eISSN - 1756-185X
pISSN - 1756-1841
DOI - 10.1111/1756-185x.12266
Subject(s) - febuxostat , hyperuricemia , medicine , allopurinol , gout , double blind , randomized controlled trial , uric acid , pathology , placebo , alternative medicine
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 C hinese gout patients with hyperuricemia. Methods Gout patients ( n = 512) with serum uric acid (s UA ) 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 s UA concentration of <6.0 mg/dL at the last three monthly measurements. Results The primary endpoint was reached in 44.77% of patients receiving 80 mg of febuxostat, 27.33% of those receiving 40 mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80 mg group was higher than in the allopurinol ( P < 0.0001) and febuxostat 40 mg ( P = 0.0008) groups. The UL efficacy of the febuxostat 40 mg group was statistically non‐inferior to that of the allopurinol group. No significant change in the number of tophi was observed during the final visit relative to baseline in each treatment group. The rate of gout flares requiring treatment from weeks 9 through 28 and the incidence of adverse events was similar among treatment groups. Conclusions The UL efficacy of daily febuxostat 80 mg was greater than that of febuxostat 40 mg and allopurinol 300 mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested.