随机双盲三模拟对照多中心临床研究非布索坦降低痛风患者高尿酸水平的疗效和安全性

目的 研究比较非布索坦与别嘌醇降低痛风（GOUT）患者血尿酸（SUA）水平的疗效和安全性.方法 486例痛风患者随机分成试验组：非布索坦40 mg组（40mg,每日1次）,非布索坦组80mg组（80mg,每日1次）和别嘌醇对照组（100 mg,每日3次）,疗程24周.主要疗效指标为24周末血尿酸水平降低到360 μmol/L以下的患者比例,次要疗效指标为2周末血尿酸水平降低到360μmol/L以下的患者比例,24周治疗前后血尿酸下降的水平和痛风发作的次数.结果 非布索坦40 mg组、非布索坦80 mg组、别嘌醇组三组意向性分析集（ITT）分析受试者末次访视SUA≤360 μmol/L的达标率分别为49.06％、65.38％、43.67％,三组疗后24周SUA降低到360 mol/L以下的受试者达标率组间比较差异有统计学意义（P＜0.0001）,具体为非布索坦40mg组与非布索坦80mg组、非布索坦80 mg组与别嘌醇组组间差异有统计学意义（P＜0.05）,非布索坦40mg组与别嘌醇组组间差异无统计学意义（P＞0.05）.总不良反应发生率在三组间差异无统计学意义.结论 非布索坦40mg组等效于别嘌醇组;非布索坦80 mag组优效于别嘌醇组,且也优效于非布索坦40mg组.非布索坦长期用于降尿酸具有良好的耐受性.

Effect and safety of febuxotant versus allopurinol in reducing serum urate in subjects with hyperuricemia and gout: a multi-center,randomized,double-blind,parallel controlled trail

Objective To compare urate-lowering （UL）efficacy and safety of daily febuxotant versus allopurinol and in subjects with gout and serum urate（SUA） ≥480 μmol/L in six-month trial.Methods Subjects（n =486） were randomized to febuxotant 40 mg or 80 mg or allopurinol 300 mg.Endpoints included the proportion of all subject with sUA≤360 μmol/L and safety assessment.Results In febuxotant 40 mg,80 mg and allopurinol group,primary endpoint was achieved in 49.06％,65.38％ and 43.67％.Febuxotant 40 mg UL was statistically noninferior to allopurinol,but febuxotant 80 mg was superior to both（P ＜0.0001）.Rates of AEs did not differ aross treatment group.Conclusions Febuxotant 40 mg group UL efficacy is similar to allopurinol group,febuxotant 80 mg group UL efficacy is better than both febuxotant 40 mg group and allopurinol group.Febuxotant 40 mg daily and febuxotant 80 mg daily treatment for 24 weeks is well tolerated.