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
Sunao Kojima, Kunihiko Matsui, Hisao Ogawa, Hideaki Jinnouchi, Shinya Hiramitsu, Takahiro Hayashi, Naoto Yokota, Naoki Kawai, Eiichi Tokutake, Kazuaki Uchiyama, Masahiro Sugawara, Hirokazu Kakuda, Yutaka Wakasa, Hisao Mori, Ichiro Hisatome, Masako Waki, Yusuke Ohya, Kazuo Kimura, Yoshihiko Saito, Febuxostat for Cerebral and Cardiorenovascular Events Prevention Study (FREED) investigators, Sunao Kojima, Kunihiko Matsui, Hisao Ogawa, Hideaki Jinnouchi, Shinya Hiramitsu, Takahiro Hayashi, Naoto Yokota, Naoki Kawai, Eiichi Tokutake, Kazuaki Uchiyama, Masahiro Sugawara, Hirokazu Kakuda, Yutaka Wakasa, Hisao Mori, Ichiro Hisatome, Masako Waki, Yusuke Ohya, Kazuo Kimura, Yoshihiko Saito, Febuxostat for Cerebral and Cardiorenovascular Events Prevention Study (FREED) investigators
Abstract
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.
Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Source: PubMed