Sunao Kojima1, Kunihiko Matsui2, Hisao Ogawa3, Hideaki Jinnouchi4, Shinya Hiramitsu5, Takahiro Hayashi6, Naoto Yokota7, Naoki Kawai8, Eiichi Tokutake9, Kazuaki Uchiyama10, Masahiro Sugawara11, Hirokazu Kakuda12, Yutaka Wakasa13, Hisao Mori14, Ichiro Hisatome15, Masako Waki16, Yusuke Ohya17, Kazuo Kimura18, Yoshihiko Saito19. 1. Kumamoto University Hospital, Kumamoto, Japan. Electronic address: kojimas@kumamoto-u.ac.jp. 2. Kumamoto University Hospital, Kumamoto, Japan. 3. National Cerebral and Cardiovascular Center, Suita, Japan. 4. Jinnouchi Clinic Diabetes Care Center, Kumamoto, Japan. 5. Hiramitsu Heart Clinic, Nagoya, Japan. 6. Hayashi Medical Clinic, Sakai, Japan. 7. Yokota Naika, Miyazaki, Japan. 8. Kawai Naika Clinic, Gifu, Japan. 9. Tokutake Iin, Kawaguchi, Japan. 10. Uchiyama Clinic, Joetsu, Japan. 11. Sugawara Clinic, Tokyo, Japan. 12. Kakuda Iin, Kahoku, Japan. 13. Wakasa Medical Clinic, Kanazawa, Japan. 14. Yokohama Sotetsu bldg Clinic of Internal Medicine, Yokohama, Japan. 15. Graduate School of Medical Science, Tottori University, Yonago, Japan. 16. Shizuoka City Hospital, Shizuoka, Japan. 17. Graduate School of Medicine, University of the Ryukyu, Nakagami, Japan. 18. Yokohama City University Medical Center, Yokohama, Japan. 19. Nara Medical University, Kashihara, Japan.
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.
RCT Entities:
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.
Authors: Caroline L Benn; Pinky Dua; Rachel Gurrell; Peter Loudon; Andrew Pike; R Ian Storer; Ciara Vangjeli Journal: Front Med (Lausanne) Date: 2018-05-31