title: 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.
abstract: 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.
  
  
  
  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.
authors.affiliation: Kumamoto University Hospital, Kumamoto, Japan. Electronic address: kojimas@kumamoto-u.ac.jp.
authors.forename: Sunao
authors.initials: S
authors.lastname: Kojima
authors.affiliation: Kumamoto University Hospital, Kumamoto, Japan.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Matsui
authors.affiliation: National Cerebral and Cardiovascular Center, Suita, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.affiliation: Jinnouchi Clinic Diabetes Care Center, Kumamoto, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Jinnouchi
authors.affiliation: Hiramitsu Heart Clinic, Nagoya, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Hiramitsu
authors.affiliation: Hayashi Medical Clinic, Sakai, Japan.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Hayashi
authors.affiliation: Yokota Naika, Miyazaki, Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Yokota
authors.affiliation: Kawai Naika Clinic, Gifu, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Kawai
authors.affiliation: Tokutake Iin, Kawaguchi, Japan.
authors.forename: Eiichi
authors.initials: E
authors.lastname: Tokutake
authors.affiliation: Uchiyama Clinic, Joetsu, Japan.
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Uchiyama
authors.affiliation: Sugawara Clinic, Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Sugawara
authors.affiliation: Kakuda Iin, Kahoku, Japan.
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Kakuda
authors.affiliation: Wakasa Medical Clinic, Kanazawa, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Wakasa
authors.affiliation: Yokohama Sotetsu bldg Clinic of Internal Medicine, Yokohama, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Mori
authors.affiliation: Graduate School of Medical Science, Tottori University, Yonago, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Hisatome
authors.affiliation: Shizuoka City Hospital, Shizuoka, Japan.
authors.forename: Masako
authors.initials: M
authors.lastname: Waki
authors.affiliation: Graduate School of Medicine, University of the Ryukyu, Nakagami, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Ohya
authors.affiliation: Yokohama City University Medical Center, Yokohama, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kimura
authors.affiliation: Nara Medical University, Kashihara, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Saito
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001927:Brain Diseases / Q000209:etiology / Q000517:prevention & control*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control*; D002423:Cause of Death; D000069465:Febuxostat / Q000627:therapeutic use*; D005260:Female; D006074:Gout Suppressants / Q000627:therapeutic use*; D006801:Humans; D033461:Hyperuricemia / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D016037:Single-Blind Method; D016896:Treatment Outcome; D014527:Uric Acid / Q000097:blood
chemical_list: D006074:Gout Suppressants; D000069465:Febuxostat; D014527:Uric Acid
keywords: Cardiorenal disease; Cerebral disease; Elderly patient; Febuxostat; Hyperuricemia