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Cardiovascular Diabetology
Published in: Cardiovascular Diabetology 1/2016

Open Access 01-12-2016 | Study protocol

Rationale and design of a multicenter randomized study for evaluating vascular function under uric acid control using the xanthine oxidase inhibitor, febuxostat: the PRIZE study

Authors: Jun-ichi Oyama, Atsushi Tanaka, Yasunori Sato, Hirofumi Tomiyama, Masataka Sata, Tomoko Ishizu, Isao Taguchi, Takanori Kuroyanagi, Hiroki Teragawa, Nobukazu Ishizaka, Yumiko Kanzaki, Mitsuru Ohishi, Kazuo Eguchi, Yukihito Higashi, Hirotsugu Yamada, Koji Maemura, Junya Ako, Yasuko K. Bando, Shinichiro Ueda, Teruo Inoue, Toyoaki Murohara, Koichi Node, On behalf of the PRIZE Study Investigators

Published in: Cardiovascular Diabetology | Issue 1/2016

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Abstract

Background

Xanthine oxidase inhibitors are anti-hyperuricemic drugs that decrease serum uric acid levels by inhibiting its synthesis. Xanthine oxidase is also recognized as a pivotal enzyme in the production of oxidative stress. Excess oxidative stress induces endothelial dysfunction and inflammatory reactions in vascular systems, leading to atherosclerosis. Many experimental studies have suggested that xanthine oxidase inhibitors have anti-atherosclerotic effects by decreasing in vitro and in vivo oxidative stress. However, there is only limited evidence on the clinical implications of xanthine oxidase inhibitors on atherosclerotic cardiovascular disease in patients with hyperuricemia. We designed the PRIZE study to evaluate the effects of febuxostat on a surrogate marker of cardiovascular disease risk, ultrasonography-based intima-media thickness of the carotid artery in patients with hyperuricemia.

Methods

The study is a multicenter, prospective, randomized, open-label and blinded-endpoint evaluation (PROBE) design. A total of 500 patients with asymptomatic hyperuricemia (uric acid >7.0 mg/dL) and carotid intima-media thickness ≥1.1 mm will be randomized centrally to receive either febuxostat (10–60 mg/day) or non-pharmacological treatment. Randomization is carried out using the dynamic allocation method stratified according to age (<65, ≥65 year), gender, presence or absence of diabetes mellitus, serum uric acid (<8.0, ≥8.0 mg/dL), and carotid intima-media thickness (<1.3, ≥1.3 mm). In addition to administering the study drug, we will also direct lifestyle modification in all participants, including advice on control of body weight, sleep, exercise and healthy diet. Carotid intima-media thickness will be evaluated using ultrasonography performed by skilled technicians at a central laboratory. Follow-up will be continued for 24 months. The primary endpoint is percentage change in mean intima-media thickness of the common carotid artery 24 months after baseline, measured by carotid ultrasound imaging.

Conclusions

PRIZE will be the first study to provide important data on the effects of febuxostat on atherosclerosis in patients with asymptomatic hyperuricemia.
Appendix
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Metadata
Title
Rationale and design of a multicenter randomized study for evaluating vascular function under uric acid control using the xanthine oxidase inhibitor, febuxostat: the PRIZE study
Authors
Jun-ichi Oyama
Atsushi Tanaka
Yasunori Sato
Hirofumi Tomiyama
Masataka Sata
Tomoko Ishizu
Isao Taguchi
Takanori Kuroyanagi
Hiroki Teragawa
Nobukazu Ishizaka
Yumiko Kanzaki
Mitsuru Ohishi
Kazuo Eguchi
Yukihito Higashi
Hirotsugu Yamada
Koji Maemura
Junya Ako
Yasuko K. Bando
Shinichiro Ueda
Teruo Inoue
Toyoaki Murohara
Koichi Node
On behalf of the PRIZE Study Investigators
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Cardiovascular Diabetology / Issue 1/2016
Electronic ISSN: 1475-2840
DOI
https://doi.org/10.1186/s12933-016-0409-2

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