title: Placebo-controlled, double-blind study of the non-purine-selective xanthine oxidase inhibitor Febuxostat (TMX-67) in patients with hyperuricemia including those with gout in Japan: phase 3 clinical study.
abstract: BACKGROUND
  : Allopurinol has been widely used for treatment of hyperuricemia, however, it may be associated with various adverse effects. Febuxostat has been identified as a potentially safe and efficacious alternative.
  
  
  OBJECTIVE
  : A multicenter study with randomized, placebo-controlled, double-blind, parallel-group comparison was carried out to evaluate the efficacy and safety of febuxostat in 103 patients with hyperuricemia (including patients with gout) in Japan.
  
  
  METHODS
  : Subjects were treated with febuxostat (20 or 40 mg/d) or a placebo for 8 weeks. The variables evaluated were the percentage of patients achieving serum uric acid levels 6.0 mg/dL or less and the percent change in serum uric acid levels after 8 weeks.
  
  
  RESULTS
  : The percentage of patients achieving serum uric acid levels 6.0 mg/dL or less after 8 weeks was 91.2% in the febuxostat 40-mg/d group, 45.7% in the 20-mg/d group, and 0.0% in the placebo group. The percent changes in serum uric acid levels after 8 weeks were -44.9% in the febuxostat 40-mg/d group, -28.9% in the 20-mg/d group, and -0.6% to -0.5% in the placebo group. No severe or medically significant adverse reaction attributable to febuxostat was noted, and there was no event that could pose a clinical problem. The efficacy did not differ depending on the presence/absence of gout history.
  
  
  CONCLUSIONS
  : These results suggest that febuxostat (20 or 40 mg/d) is useful as a new means of treating hyperuricemia and is capable of reducing serum uric acid levels to 6.0 mg/dL or less (goal of treatment) with high safety regardless of the presence/absence of gout history.
authors.affiliation: Institute of Rheumatology, Tokyo Women's Medical University, Japan. kamatani@msb.biglobe.ne.jp
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Kamatani
authors.forename: Kamatani
authors.initials: K
authors.lastname: Naoyuki
authors.forename: Shin
authors.initials: S
authors.lastname: Fujimori
authors.forename: Fujimori
authors.initials: F
authors.lastname: Shin
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Hada
authors.forename: Hada
authors.initials: H
authors.lastname: Toshikazu
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Hosoya
authors.forename: Hosoya
authors.initials: H
authors.lastname: Tatsuo
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Kohri
authors.forename: Kohri
authors.initials: K
authors.lastname: Kenjiro
authors.forename: Toshitaka
authors.initials: T
authors.lastname: Nakamura
authors.forename: Nakamura
authors.initials: N
authors.lastname: Toshitaka
authors.forename: Takanori
authors.initials: T
authors.lastname: Ueda
authors.forename: Ueda
authors.initials: U
authors.lastname: Takanori
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Yamamoto
authors.forename: Yamamoto
authors.initials: Y
authors.lastname: Tetsuya
authors.forename: Hisashi
authors.initials: H
authors.lastname: Yamanaka
authors.forename: Yamanaka
authors.initials: Y
authors.lastname: Hisashi
authors.forename: Yuji
authors.initials: Y
authors.lastname: Matsuzawa
authors.forename: Matsuzawa
authors.initials: M
authors.lastname: Yuji
mesh_terms: D000328:Adult; D002493:Central Nervous System Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D003743:Dental Enamel / Q000002:abnormalities; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D000069465:Febuxostat; D005260:Female; D005500:Follow-Up Studies; D006073:Gout / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D006074:Gout Suppressants / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D052177:Kidney Diseases, Cystic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013844:Thiazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood*; D014969:Xanthine Oxidase / Q000037:antagonists & inhibitors* / Q000097:blood
chemical_list: D006074:Gout Suppressants; D013844:Thiazoles; D000069465:Febuxostat; D014527:Uric Acid; D014969:Xanthine Oxidase