| Item type |
学術雑誌論文 / Journal Article_02(1) |
| 公開日 |
2025-05-27 |
| タイトル |
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タイトル |
Study protocol of the PROUD48 study comparing the effects of pemafibrate and omega-3 fatty acid ethyl esters on ApoB-48 in statin-treated patients with dyslipidaemia: a prospective, multicentre, open-label, randomised, parallel group trial in Japan |
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言語 |
en |
| 言語 |
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言語 |
eng |
| キーワード |
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主題Scheme |
Other |
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キーワード |
Clinical trials |
| キーワード |
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主題Scheme |
Other |
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キーワード |
Diabetes & endocrinology |
| キーワード |
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主題Scheme |
Other |
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キーワード |
Lipid disorders |
| キーワード |
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主題Scheme |
Other |
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キーワード |
Vascular medicine |
| 資源タイプ |
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資源タイプ |
journal article |
| アクセス権 |
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アクセス権 |
open access |
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アクセス権URI |
http://purl.org/coar/access_right/c_abf2 |
| 著者 |
Yasutaka, Takeda
Ichiro, Sakuma
Shinya, Hiramitsu
Mizuho, Okada
Shinichiro, Ueda
Masaru, Sakurai
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| bibliographic_information |
en : BMJ Open
巻 12,
号 11,
p. e061360,
発行日 2022-11-14
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| ISSN |
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収録物識別子タイプ |
EISSN |
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収録物識別子 |
2044-6055 |
| DOI |
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関連タイプ |
isIdenticalTo |
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識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.1136/bmjopen-2022-061360 |
| リンクURL |
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内容記述タイプ |
Other |
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内容記述 |
https://bmjopen.bmj.com/content/12/11/e061360 |
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言語 |
en |
| item_1716186501932 |
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関連タイプ |
isIdenticalTo |
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識別子タイプ |
PMID |
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関連識別子 |
36375977 |
| item_5_description_33 |
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内容記述タイプ |
Abstract |
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内容記述 |
Introduction: This study will compare the lowering effects of pemafibrate and omega-3 fatty acid ethyl esters on fasting apolipoprotein B-48 (apoB-48), a surrogate marker reflecting postprandial hypertriglyceridaemia, which is a residual risk for atherosclerotic cardiovascular disease with statin treatment.
Methods and analysis: This is a prospective, multicentre, open-label, randomised, parallel group, comparative trial. Adult Japanese patients with dyslipidaemia receiving statin treatment for more than 4 weeks with a fasting triglyceride level ≥177 mg/dL will be randomly assigned in a 1:1 ratio to receive pemafibrate (0.4 mg orally per day) or omega-3 fatty acid ethyl esters (4 g orally per day) for 16 weeks. The primary endpoint is the percentage change in fasting apoB-48 from baseline to 16 weeks. The key secondary endpoints include the change in fasting apoB-48 from baseline to 16 weeks, the percentage changes in clinical variables from baseline to 16 weeks and the incidence of adverse events. A total sample size of 128 was set by considering the increased drop-out rate due to the COVID-19 pandemic, in addition to estimation based on a two-sided alpha of 0.05 and a power of 0.8 for apoB-48.
Ethics and dissemination: The study protocol has been approved by the Certified Review Board of the University of the Ryukyus for Clinical Research Ethics (No. CRB7200001) and will be performed in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants. The results of the study will be disseminated through publications and conference presentations to participants, healthcare professionals and the public.
Trial registration number: jRCTs071200011. |
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言語 |
en |
| 注記 |
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内容記述タイプ |
Other |
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注記 |
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
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言語 |
en |
| 出版タイプ |
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出版タイプ |
VoR |
| item_5_textarea_42 |
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en |
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© Author(s) (or their employer(s)) 2022 |
36375977.pdf (487 KB)
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