单位：[1]Renji Hospital, School of Medicine, Shanghai Jiaotong University,Shanghai[2]The Third Affiliated Hospital, Sun Yat-Sen University,Guangzhou中山大学附属第三医院[3]Second Hospital of Shanxi Medical University,Taiyuan[4]The First Bethune Hospital of Jilin University, Changchun[5]Shengjing Hospital of China Medical University, Shenyang中国医科大学附属盛京医院[6]WestChina Hospital, Sichuan University[7]Sichuan Academy of MedicalSciences and Sichuan Provincial People’s Hospital, Chengdu四川省人民医院[8]TheFirst Affiliated Hospital of Bengbu Medical College, Bengbu[9]Xinhua Hospital Affiliated to Shanghai Jiaotong University Schoolof Medicine, Shanghai[10]The First Affiliated Hospital of USTC AnhuiProvincial Hospital, Hefei[11]China-Japan Union Hospital of JilinUniversity, Changchun吉林大学中日联谊医院[12]Zhongshan Hospital Affiliated to FudanUniversity, Shanghai[13]The First Affiliated Hospital of SooChowUniversity, Suzhou[14]Chongqing Sanxia Central Hospital, Wanzhou,[15]Guangzhou First People’s Hospital, Guangzhou[16]China-JapanFriendship Hospital, Beijing[17]The First Affiliated Hospital ofNanchang University, Nanchang[18]The First Affiliated Hospital ofHainan Medical College, Haikou[19]Shanghai Tenth People’sHospital, Shanghai[20]Xiangya Hospital Central South University,Changsha[21]Jiangsu Hengrui Medicine Co., Ltd, Shanghai,China
Objective. To evaluate the efficacy and safety of SHR4640, a highly selective urate transporter 1 inhibitor, in Chinese subjects with hyperuricaemia. Methods. This was a randomized double-blind dose-ranging phase II study. Subjects whose serum uric acid (sUA) levels were >= 480 mu mol/l with gout, >= 480 mu mol/l without gout but with comorbidities, or >= 540 mu mol/l were enrolled. Subjects were randomly assigned (1:1:1:1:1) to receive once daily 2.5 mg, 5 mg, 10mg of SHR4640, 50mg of benzbromarone or placebo, respectively. The primary end point was the proportion of subjects who achieved target sUA level of <= 360 mu mol/l at week 5. Results. 99.5% of subjects (n = 197) were male and 95.9% of subjects had gout history. The proportions of subjects who achieved target sUA at week 5 were 32.5%, 72.5% and 61.5% in the 5 mg, 10 mg SHR4640 and benzbromarone groups, respectively, significantly higher than the placebo group (0%; P<0.05 for 5 mg and 10 mg SHR4640 group). The sUA was reduced by 32.7%, 46.8% and 41.8% at week 5 with 5 mg, 10 mg SHR4640 and benzbromarone, respectively, vs placebo (5.9%; P<0.001 for each comparison). The incidences of gout flares requiring intervention were similar among all groups. Occurrences of treatment-emergent adverse events (TEAEs) were comparable across all groups, and serious TEAEs were not reported. Conclusions. The present study indicated a superior sUA-lowering effect and well tolerated safety profile after 5-week treatment with once-daily 5 mg/10 mg of SHR4640 as compared with placebo in Chinese subjects with hyperuricaemia.
第一作者单位：[1]Renji Hospital, School of Medicine, Shanghai Jiaotong University,Shanghai
共同第一作者：
通讯作者：
通讯机构：[1]Renji Hospital, School of Medicine, Shanghai Jiaotong University,Shanghai[*1]Renji Hospital, School of Medicine, Shanghai Jiaotong University, No. 160 Pujian Road, Pudong District, Shanghai 200127, China
推荐引用方式(GB/T 7714)：
Yanwei Lin,Xiaoxiang Chen,Huihua Ding,et al.Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study[J].RHEUMATOLOGY.2021,60(11):5089-5097.doi:10.1093/rheumatology/keab198.
APA：
Yanwei Lin,Xiaoxiang Chen,Huihua Ding,Ping Ye,Jieruo Gu...&Chunde Bao.(2021).Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study.RHEUMATOLOGY,60,(11)
MLA：
Yanwei Lin,et al."Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study".RHEUMATOLOGY 60..11(2021):5089-5097
