| Item type |
文献 / Documents(1) |
| 公開日 |
2020-11-26 |
| アクセス権 |
|
|
アクセス権 |
open access |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版社版DOI |
|
|
|
識別子タイプ |
DOI |
|
|
関連識別子 |
https://doi.org/10.1186/s12933-016-0409-2 |
|
|
言語 |
ja |
|
|
関連名称 |
10.1186/s12933-016-0409-2 |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
|
|
タイトル |
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 |
|
言語 |
en |
| 著者 |
オヤマ, ジュンイチ
タナカ, アツシ
サトウ, ヤスノリ
トミヤマ, ヒロフミ
佐田, 政隆
イシヅ, トモコ
タグチ, イサオ
クロヤナギ, タカノリ
テラガワ, ヒロキ
イシザカ, ノブカズ
カンザキ, ユミコ
オオイシ, ミツル
エグチ, カズオ
ヒガシ, ユキヒト
山田, 博胤
マエムラ, コウジ
アコ, ジュンヤ
バンドウ, ヤスコ
ウエダ, シンイチロウ
イノウエ, テルオ
ムロハラ, トヨアキ
ノデ, コウイチ
|
| 抄録 |
|
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内容記述タイプ |
Abstract |
|
内容記述 |
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. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Carotid artery |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Febuxostat |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Hyperuricemia |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Intima-media thickness (IMT) |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Randomized controlled trial |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Xanthine oxidase inhibitor |
| 書誌情報 |
en : Cardiovascular Diabetology
巻 15,
p. 87,
発行日 2016-06-18
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| 収録物ID |
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収録物識別子タイプ |
ISSN |
|
収録物識別子 |
14752840 |
| 出版者 |
|
|
出版者 |
Springer Nature |
|
言語 |
en |
| 出版者 |
|
|
出版者 |
BioMed Central |
|
言語 |
en |
| 権利情報 |
|
|
言語 |
en |
|
権利情報 |
© 2016 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| EID |
|
|
識別子 |
313985 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
cardiab_15_87.pdf (921 KB)
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