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

J Clin Rheumatol. 2011 Jun;17(4 Suppl 2):S19-26. doi: 10.1097/RHU.0b013e31821d36de.


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.

Objectives: : 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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Central Nervous System Diseases / blood
  • Central Nervous System Diseases / complications
  • Central Nervous System Diseases / drug therapy*
  • Dental Enamel / abnormalities
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Febuxostat
  • Female
  • Follow-Up Studies
  • Gout / blood
  • Gout / complications
  • Gout / drug therapy*
  • Gout Suppressants / administration & dosage
  • Gout Suppressants / therapeutic use*
  • Humans
  • Japan
  • Kidney Diseases, Cystic / blood
  • Kidney Diseases, Cystic / complications
  • Kidney Diseases, Cystic / drug therapy*
  • Male
  • Middle Aged
  • Thiazoles / administration & dosage
  • Thiazoles / therapeutic use*
  • Treatment Outcome
  • Uric Acid / blood*
  • Xanthine Oxidase / antagonists & inhibitors*
  • Xanthine Oxidase / blood


  • Gout Suppressants
  • Thiazoles
  • Febuxostat
  • Uric Acid
  • Xanthine Oxidase

Supplementary concepts

  • Renal cysts and diabetes syndrome