Efficacy and safety of a selective URAT1 inhibitor SHR4640 in Chinese subjects with hyperuricaemia: a randomized controlled phase II study

To evaluate the efficacy and safety of SHR4640, a highly selective urate transporter 1 inhibitor, in Chinese subjects with hyperuricaemia. This was a randomized double-blind dose-ranging phase II study. Subjects whose serum uric acid (sUA) levels were ≥480 µmol/l with gout, ≥480 µmol/l without gout...

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Published in:Rheumatology (Oxford, England) England), 2021-11, Vol.60 (11), p.5089-5097
Main Authors: Lin, Yanwei, Chen, Xiaoxiang, Ding, Huihua, Ye, Ping, Gu, Jieruo, Wang, Xiaoxia, Jiang, Zhenyu, Li, Detian, Wang, Zhongming, Long, Wubin, Li, Zhijun, Jiang, Gengru, Li, Xiaomei, Bi, Liqi, Jiang, Lindi, Wu, Jian, Guo, Lian, Cai, Xiaoyan, Lu, Xin, Chen, Qinkai, Chen, Hong, Peng, Ai, Zuo, Xiaoxia, Ning, Rui, Zhang, Zhe, Tai, Yanfei, Zhang, Tao, Bao, Chunde
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Double-Blind Method
Female
Humans
Hyperuricemia - drug therapy
Kidney Diseases - chemically induced
Male
Middle Aged
Organic Anion Transporters - antagonists & inhibitors
Organic Cation Transport Proteins - antagonists & inhibitors
Treatment Outcome
Young Adult
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Summary:To evaluate the efficacy and safety of SHR4640, a highly selective urate transporter 1 inhibitor, in Chinese subjects with hyperuricaemia. This was a randomized double-blind dose-ranging phase II study. Subjects whose serum uric acid (sUA) levels were ≥480 µmol/l with gout, ≥480 µmol/l without gout but with comorbidities, or ≥540 µmol/l were enrolled. Subjects were randomly assigned (1:1:1:1:1) to receive once daily 2.5 mg, 5 mg, 10 mg of SHR4640, 50 mg of benzbromarone or placebo, respectively. The primary end point was the proportion of subjects who achieved target sUA level of ≤360 µmol/l at week 5. 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 
ISSN:1462-0324
1462-0332
DOI:10.1093/rheumatology/keab198