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.
Abstract | BACKGROUND: 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. Trial Registration Unique trial Number, UMIN000012911 ( https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000015081&language=E ).
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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, PRIZE Study Investigators |
Journal | Cardiovascular diabetology
(Cardiovasc Diabetol)
Vol. 15
Pg. 87
(Jun 18 2016)
ISSN: 1475-2840 [Electronic] England |
PMID | 27317093
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Enzyme Inhibitors
- Febuxostat
- Uric Acid
- Xanthine Oxidase
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Atherosclerosis
(drug therapy)
- Carotid Artery, Common
(drug effects)
- Dose-Response Relationship, Drug
- Enzyme Inhibitors
(therapeutic use)
- Febuxostat
(therapeutic use)
- Female
- Humans
- Hyperuricemia
(blood, drug therapy)
- Male
- Middle Aged
- Prospective Studies
- Risk Factors
- Uric Acid
(blood)
- Xanthine Oxidase
(antagonists & inhibitors)
- Young Adult
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