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

Abstract

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. Gout patients (n=512) with serum uric acid (sUA) concentrations of at least 8.0mg/dL were randomized to receive daily febuxostat 40mg or 80mg or allopurinol 300mg for 28weeks. 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 <6.0mg/dL at the last three monthly measurements. The primary endpoint was reached in 44.77% of patients receiving 80mg of febuxostat, 27.33% of those receiving 40mg of febuxostat, and 23.84% of those receiving allopurinol. The UL efficacy in the febuxostat 80mg group was higher than in the allopurinol (P<0.0001) and febuxostat 40mg (P=0.0008) groups. The UL efficacy of the febuxostat 40mg 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. The UL efficacy of daily febuxostat 80mg was greater than that of febuxostat 40mg and allopurinol 300mg, which exhibited comparable UL efficacy. Safety of febuxostat and allopurinol was comparable at the doses tested.