Rationale, design, and baseline characteristics of a study to evaluate the effect of febuxostat in preventing cerebral, cardiovascular, and renal events in patients with hyperuricemia

J Cardiol. 2017 Jan;69(1):169-175. doi: 10.1016/j.jjcc.2016.02.015. Epub 2016 Apr 20.


Background: Since uric acid is associated with cardiovascular and renal disease, a treatment to maintain blood uric acid level may be required in patients with hyperuricemia. This study aims to evaluate preventive effects of febuxostat, a selective xanthine oxidase inhibitor, on cerebral, cardiovascular, and renal events in patients with hyperuricemia compared to conventional treatment.

Methods and results: This study is a prospective randomized open-label blinded endpoint study. Patient enrolment was started in November 2013 and was completed in October 2014. The patients will be followed for at least 3 years. The primary endpoint is a composite of cerebral, cardiovascular, and renal events, and all deaths including death due to cerebral, cardiovascular, and renal disease, new or recurring cerebrovascular disease, new or recurring non-fatal coronary artery disease, cardiac failure requiring hospitalization, arteriosclerotic disease requiring treatment, renal impairment, new atrial fibrillation, and all deaths other than cerebral or cardiovascular or renal disease. These events will be independently evaluated by the Event Assessment Committee under blinded information regarding the treatment group. The study was registered at ClinicalTrials.gov with the identifier NCT01984749.

Keywords: Cardiorenal disease; Cerebral disease; Elderly patient; Febuxostat; Hyperuricemia.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Brain Diseases / etiology
  • Brain Diseases / prevention & control*
  • Cardiovascular Diseases / etiology
  • Cardiovascular Diseases / prevention & control*
  • Cause of Death
  • Febuxostat / therapeutic use*
  • Female
  • Gout Suppressants / therapeutic use*
  • Humans
  • Hyperuricemia / blood
  • Hyperuricemia / complications
  • Hyperuricemia / drug therapy*
  • Male
  • Middle Aged
  • Prospective Studies
  • Renal Insufficiency / etiology
  • Renal Insufficiency / prevention & control*
  • Research Design
  • Single-Blind Method
  • Treatment Outcome
  • Uric Acid / blood


  • Gout Suppressants
  • Febuxostat
  • Uric Acid

Associated data

  • ClinicalTrials.gov/NCT01984749