机构：[1]Department of Endocrinology, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China南方医科大学珠江医院[2]Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, China[3]Department of Rheumatology, Beijing Hospital, National Centre of Gerontology, Beijing, China[4]Department of Rheumatology, Foshan First People’s Hospital, Foshan, Guangdong, China[5]Department of Rheumatology, Jiangxi Pingxiang People’s Hospital, Pingxiang, Jiangxi, China[6]Department of Rheumatology, Shenzhen People’s Hospital, Shenzhen, Guangdong, China深圳市康宁医院深圳市人民医院深圳医学信息中心[7]Department of Endocrinology, Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital), Dalian, Liaoning, China大连市中心医院[8]Department of Metabolic Diseases, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China[9]Department of Endocrinology, The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China[10]Department of Rheumatology, The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China[11]Department of Rheumatology and Immunology, Tong Ren Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China[12]Department of Rheumatology, The First Hospital of Jilin University, Changchun, Jilin, China[13]Department of Nephrology and Rheumatology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China[14]Department of Rheumatology and Immunology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, China大连医科大学附属第一医院[15]Department of Rheumatology, Jieyang People’s Hospital, Jieyang, Guangdong, China[16]Eisai China Inc., Beijing, China[17]Eisai Co. Ltd., Bunkyo, Tokyo, Japan
Dotinurad is a selective urate reabsorption inhibitor that reduces serum urate levels. We compared the efficacy and safety of dotinurad with febuxostat in Chinese patients with gout.This phase 3, multicentre, randomised, double-blind, parallel-group study randomly allocated (1:1) eligible patients with gout to receive oral dotinurad or febuxostat. The primary endpoint was the responder rate (proportion of patients achieving serum urate levels ≤6.0 mg/dL) at week 24 in the full analysis set (FAS) to demonstrate superiority of dotinurad 4 mg/day to febuxostat 40 mg/day. The secondary endpoints included the responder rate at week 12 to show the non-inferiority of dotinurad 2 mg/day to febuxostat 40 mg/day. Treatment-emergent adverse events (TEAEs) were also recorded.A total of 451 patients were randomised and 441 were included in the FAS. Baseline characteristics were well-balanced between treatment groups. The responder rate at week 24 was significantly higher for dotinurad 4 mg/day vs febuxostat 40 mg/day (73.6% vs 38.1%; adjusted difference 35.9% [95% confidence interval (CI) 27.4%, 44.4%]; p<0.0001), and that at week 12 in the dotinurad 2 mg/day was non-inferior to the febuxostat 40 mg/day (55.5% vs 50.5%; adjusted difference 5.2% [95% CI -3.7%, 14.2%]). Incidences of TEAEs in the dotinurad and febuxostat groups were similar.Dotinurad 4 mg/day was superior to febuxostat 40 mg/day in achieving serum urate levels ≤6.0 mg/dL at week 24 and was well tolerated in Chinese patients with gout.This article is protected by copyright. All rights reserved.
基金：
This research was funded by Eisai Co., Ltd.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
大类|1 区医学
小类|1 区风湿病学
最新[2025]版：
大类|1 区医学
小类|1 区风湿病学
第一作者：
第一作者机构：[1]Department of Endocrinology, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
通讯作者：
推荐引用方式(GB/T 7714)：
Sun Jia,Wang Yu,Cheng Yongjing,et al.Efficacy and safety of dotinurad versus febuxostat for the treatment of gout: a randomised, multicentre, double-blind, phase 3 trial in China[J].Arthritis & Rheumatology (Hoboken, N.J.).2025,doi:10.1002/art.43261.
APA：
Sun Jia,Wang Yu,Cheng Yongjing,Guo Dongmei,Hu Jiankang...&Zhang Zhuoli.(2025).Efficacy and safety of dotinurad versus febuxostat for the treatment of gout: a randomised, multicentre, double-blind, phase 3 trial in China.Arthritis & Rheumatology (Hoboken, N.J.),,
MLA：
Sun Jia,et al."Efficacy and safety of dotinurad versus febuxostat for the treatment of gout: a randomised, multicentre, double-blind, phase 3 trial in China".Arthritis & Rheumatology (Hoboken, N.J.) .(2025)
医学