| Item type |
文献 / Documents(1) |
| 公開日 |
2020-11-30 |
| アクセス権 |
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アクセス権 |
open access |
| 資源タイプ |
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資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
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資源タイプ |
journal article |
| 出版社版DOI |
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関連識別子 |
https://doi.org/10.1186/s12944-017-0513-7 |
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関連名称 |
10.1186/s12944-017-0513-7 |
| 出版タイプ |
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|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
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|
タイトル |
Efficacy and safety of alirocumab in patients with hypercholesterolemia not adequately controlled with non-statin lipid-lowering therapy or the lowest strength of statin : ODYSSEY NIPPON study design and rationale |
| 著者 |
テラモト, タミオ
コンドウ, アキラ
キヨスエ, アリヒロ
ハラダ シバ, マリコ
イシガキ, ヤスシ
トビタ, キミマサ
カワバタ, ユミコ
オザキ, アスカ
Baccara-Dinet, Marie T.
佐田, 政隆
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| 抄録 |
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内容記述 |
Background: Statins are generally well-tolerated and serious side effects are infrequent, but some patients experience adverse events and reduce their statin dose or discontinue treatment altogether. Alirocumab is a highly specific, fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9), which can produce substantial and sustained reductions of low-density lipoprotein cholesterol (LDL-C).
Methods: The randomized, double-blind, placebo-controlled, parallel-group, phase 3 ODYSSEY NIPPON study will explore alirocumab 150 mg every 4 weeks (Q4W) in 163 Japanese patients with hypercholesterolemia who are on the lowest-strength dose of atorvastatin (5 mg/day) or are receiving a non-statin lipid-lowering therapy (LLT) (fenofibrate, bezafibrate, ezetimibe, or diet therapy alone). Hypercholesterolemia is defined as LDL-C ≥ 100 mg/dL (2.6 mmol/L) in patients with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia with a history of documented coronary heart disease, or ≥120 mg/dL (3.1 mmol/L) in patients with non-familial hypercholesterolemia classified as primary prevention category III (i.e. high-risk patients). During the 12-week double-blind treatment period, patients will be randomized (1:1:1) to receive alirocumab subcutaneously (SC) 150 mg Q4W alternating with placebo for alirocumab Q4W, or alirocumab 150 mg SC every 2 weeks (Q2W), or SC placebo Q2W. The primary efficacy endpoint is the percentage change in calculated LDL-C from baseline to week 12. The long-term safety and tolerability of alirocumab will also be investigated.
Discussion: The ODYSSEY NIPPON study will provide insights into the efficacy and safety of alirocumab 150 mg Q4W or 150 mg Q2W among Japanese patients with hypercholesterolemia who are on the lowest-strength dose of atorvastatin, or are receiving a non-statin LLT (including diet therapy alone). |
| キーワード |
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|
主題 |
Alirocumab |
| キーワード |
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|
主題 |
Hypercholesterolemia |
| キーワード |
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|
主題 |
Statin |
| キーワード |
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|
主題 |
Statin intolerance |
| キーワード |
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|
主題 |
Cardiovascular risk |
| キーワード |
|
|
主題 |
PCSK9 inhibitor |
| キーワード |
|
|
主題 |
Lipids |
| 書誌情報 |
en : Lipids in Health and Disease
巻 16,
p. 121,
発行日 2017-06-17
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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 |
1476511X |
| 出版者 |
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|
出版者 |
BioMed Central |
| 出版者 |
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|
出版者 |
Springer Nature |
| 権利情報 |
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|
権利情報 |
© The Author(s). 2017 Open Access 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 |
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|
識別子 |
327197 |
| 言語 |
|
|
言語 |
eng |
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