A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia

doi:10.1111/1756-185X.12648

CORC > 兰州大学 > 兰州大学 > 第二临床医学院 > 期刊论文

	A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia
	Xu, SY; Liu, XY; Ming, J; Chen, SR; Wang, YG; Liu, XM; Liu, H; Peng, YD; Wang, JQ; Lin, JY
刊名	INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES
	2015-07
卷号	18 期号:6 页码:669-678
关键词	allopurinol febuxostat gout hyperuricemia
ISSN号	1756-1841
DOI	10.1111/1756-185X.12648
文献子类	Article
英文摘要	AimTo compare the efficiency and safety of febuxostat with those of allopurinol in Chinese patients with gout and hyperuricemia. MethodsThe trial which was conducted at 13 centers in China during 2011-2013 included a 2-week run-in and a 24-week treatment period. A total of 504 eligible participants with gout and with serum urate 480mol/L were randomly assigned 1:1:1 to febuxostat 40mg/day, febuxostat 80mg/day and allopurinol 300mg/day groups. The primary efficacy endpoint was the percentage of subjects whose last three serum urate levels were <360mol/L. ResultsThe primary efficacy endpoint was reached by 33.5% of subjects taking febuxostat 80mg/day, 22.5% of those taking febuxostat 40mg/day and 17.0% of those taking allopurinol 300mg/day (P<0.001 for the comparison between febuxostat 80mg/day and allopurinol 300mg/day groups; P=0.216 for the comparison between febuxostat 40mg/day and allopurinol 300mg/day groups). The incidence of gout flare was relatively high in each group during the first 8weeks and gradually decreased thereafter. There was no statistically significant difference between the three groups (P>0.05). The incidence of adverse events was similar in the three treatment groups. The most frequent treatment-related adverse events were liver function test abnormalities. ConclusionsFebuxostat 80mg/day had superior urate-lowering efficacy to that of febuxostat 40mg/day or allopurinol 300mg/day, which was comparable in Chinese gout patients with hyperuricemia. Febuxostat, at a daily dose of 40 or 80mg, was safe and well tolerated.
学科主题	Rheumatology
出版地	HOBOKEN
项目编号	Qingdao Shengbang Pharmaceutical Corporation Limited, Shandong, China [ChiCTR: 2010L04287, 2010L04288]
语种	英语
WOS记录号	WOS:000360378700010
内容类型	期刊论文
源URL	[http://ir.lzu.edu.cn/handle/262010/179368]
专题	第二临床医学院_期刊论文
通讯作者	Ji, QH (reprint author), Fourth Mil Med Univ, Xijing Hosp, Dept Endocrinol, 169 Changle Rd West, Xian 710032, Peoples R China.
推荐引用方式 GB/T 7714	Xu, SY,Liu, XY,Ming, J,et al. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia[J]. INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES,2015,18(6):669-678.
APA	Xu, SY.,Liu, XY.,Ming, J.,Chen, SR.,Wang, YG.,...&Ji, QH .(2015).A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia.INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES,18(6),669-678.
MLA	Xu, SY,et al."A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia".INTERNATIONAL JOURNAL OF RHEUMATIC DISEASES 18.6(2015):669-678.