title: Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study.
abstract: OBJECTIVE
  This phase IIIB study compared the efficacy and safety of febuxostat and allopurinol in gout patients with or without tophi who were HLA-B*5801 negative.
  
  
  METHODS
  Eligible patients were randomized to a febuxostat group (80 mg QD) or an allopurinol group (300 mg QD). Following an initial 2-week washout period, over the next 12 weeks we made five measurements of serum urate levels along with assessments of adverse events (AEs).
  
  
  RESULTS
  Forty-three out of 152 screened subjects (28.3%) were ineligible either because of the presence of the HLA-B*5801 allele or for various other reasons. The febuxostat group (n = 54) and the allopurinol group (n = 55) had no significant differences in demographic or baseline characteristics. From week 2 to week 12, the febuxostat group had a significantly lower serum urate level than the allopurinol group (p ≤ 0.001 for all comparisons) and significantly more patients with serum urate levels less than 6.0 mg/dL. The serum urate levels of the febuxostat group declined by more than 40% from week 2 to week 12 and this decrease was greater than that in the allopurinol group (~30%). The two groups were similar in terms of AEs.
  
  
  CONCLUSIONS
  Febuxostat was more effective than allopurinol in reducing the serum urate levels of Han Chinese patients with gout or tophaceous gout who were HLA-B*5801 negative, without causing any serious skin reactions. Febuxostat should be considered for treatment of Han Chinese patients with gout who are HLA-B*5801 negative.
authors.affiliation: a Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine , Chang Gung Memorial Hospital and Chang Gung University , Taoyuan , Taiwan , ROC.
authors.forename: K-H
authors.initials: KH
authors.lastname: Yu
authors.affiliation: b Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine , Chang Gung Memorial Hospital, Chang Gung University and School of Medicine, National Defense Medical Center , Taipei , Taiwan , ROC.
authors.forename: J-H
authors.initials: JH
authors.lastname: Lai
authors.affiliation: c Department of Internal Medicine , National Taiwan University Hospital , Taipei , Taiwan , ROC.
authors.forename: P-N
authors.initials: PN
authors.lastname: Hsu
authors.affiliation: d Faculty of Medicine , National Yang-Ming University , Taipei , Taiwan , ROC.|e Department of Medical Education and Research , Taichung Veterans General Hospital , Taichung , Taiwan , ROC.|f Institute of Biomedical Science , National Chung-Hsing University , Taichung , Taiwan , ROC.|g Institute of Microbiology and Immunology , Chung Shan Medical University , Taichung , Taiwan , ROC.
authors.forename: D-Y
authors.initials: DY
authors.lastname: Chen
authors.affiliation: h Department of Internal Medicine , Kaohsiung Medical University Hospital , Kaohsiung , Taiwan , ROC.
authors.forename: C-J
authors.initials: CJ
authors.lastname: Chen
authors.affiliation: i Division of Allergy, Immunology and Rheumatology , Taipei Veterans General Hospital and National Yang-Ming University School of Medicine , Taipei , Taiwan , ROC.|j Taipei Medical University , School of Medicine , Taipei , Taiwan , ROC.
authors.forename: H-Y
authors.initials: HY
authors.lastname: Lin
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000483:Alleles; D000493:Allopurinol / Q000627:therapeutic use; D002681:China; D000069465:Febuxostat / Q000627:therapeutic use*; D005260:Female; D006073:Gout / Q000097:blood / Q000188:drug therapy* / Q000235:genetics; D006074:Gout Suppressants / Q000627:therapeutic use*; D015235:HLA-B Antigens / Q000235:genetics; D006801:Humans; D033461:Hyperuricemia / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood
chemical_list: D006074:Gout Suppressants; D015235:HLA-B Antigens; C500126:HLA-B*58:01 antigen; D000069465:Febuxostat; D014527:Uric Acid; D000493:Allopurinol