title: A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia.
abstract: OBJECTIVE
  To compare the efficiency and safety of febuxostat with those of allopurinol in Chinese patients with gout and hyperuricemia.
  
  
  METHODS
  The 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 ≥ 480 μmol/L were randomly assigned 1 : 1 : 1 to febuxostat 40 mg/day, febuxostat 80 mg/day and allopurinol 300 mg/day groups. The primary efficacy endpoint was the percentage of subjects whose last three serum urate levels were < 360 μmol/L.
  
  
  RESULTS
  The primary efficacy endpoint was reached by 33.5% of subjects taking febuxostat 80 mg/day, 22.5% of those taking febuxostat 40 mg/day and 17.0% of those taking allopurinol 300 mg/day (P < 0.001 for the comparison between febuxostat 80 mg/day and allopurinol 300 mg/day groups; P = 0.216 for the comparison between febuxostat 40 mg/day and allopurinol 300 mg/day groups). The incidence of gout flare was relatively high in each group during the first 8 weeks 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.
  
  
  CONCLUSIONS
  Febuxostat 80 mg/day had superior urate-lowering efficacy to that of febuxostat 40 mg/day or allopurinol 300 mg/day, which was comparable in Chinese gout patients with hyperuricemia. Febuxostat, at a daily dose of 40 or 80 mg, was safe and well tolerated.
authors.affiliation: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Shaoyong
authors.initials: S
authors.lastname: Xu
authors.affiliation: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Xiangyang
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Ming
authors.affiliation: Department of Endocrinology, the Second Affiliated Hospital of Shantou University Medical College, Shantou, China.
authors.forename: Shenren
authors.initials: S
authors.lastname: Chen
authors.affiliation: Department of Endocrinology, the Affiliated Hospital of Qingdao University, Qingdao, China.
authors.forename: Yangang
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Rheumatology, the First Hospital of Shanxi Medical University, Taiyuan, China.
authors.forename: Xiumei
authors.initials: X
authors.lastname: Liu
authors.affiliation: Department of Endocrinology, the First Affiliated Hospital of Guangxi Medical University, Nanning, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Liu
authors.affiliation: Department of Endocrinology, Shanghai General Hospital, Shanghai, China.
authors.forename: Yongde
authors.initials: Y
authors.lastname: Peng
authors.affiliation: Department of Nephrology, Lanzhou University Second Hospital, Lanzhou, China.
authors.forename: Jianqin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Hematology, the People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, China.
authors.forename: Jinying
authors.initials: J
authors.lastname: Lin
authors.affiliation: Department of Traditional Chinese Medicine and Rheumatology, Shaanxi Provincial People's Hospital, Xi'an, China.
authors.forename: Haiwang
authors.initials: H
authors.lastname: Ji
authors.affiliation: Department of Hand and Foot Surgery, the First Hospital of Jilin University, Jilin, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Liu
authors.affiliation: Department of Nephrology, Zhejiang Provincial Tongde Hospital, Hangzhou, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Lu
authors.affiliation: Department of Endocrinology, Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine, Nanning, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Liu
authors.affiliation: Department of Rheumatology, Luoyang Orthopedic-Traumatological Hospital, Luoyang, China.
authors.forename: Yonghong
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: Qiuhe
authors.initials: Q
authors.lastname: Ji
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000493:Allopurinol / Q000008:administration & dosage* / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood; D002681:China; D004311:Double-Blind Method; D000069465:Febuxostat / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006073:Gout / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006074:Gout Suppressants / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D033461:Hyperuricemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood
chemical_list: D015415:Biomarkers; D006074:Gout Suppressants; D000069465:Febuxostat; D014527:Uric Acid; D000493:Allopurinol
keywords: allopurinol; febuxostat; gout; hyperuricemia