| Item type |
文献 / Documents(1) |
| 公開日 |
2019-04-12 |
| アクセス権 |
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|
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/10.1016/j.jjcc.2018.10.004 |
|
|
言語 |
ja |
|
|
関連名称 |
10.1016/j.jjcc.2018.10.004 |
| 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 |
Efficacy and safety of alirocumab 150 mg every 4 weeks in hypercholesterolemic patients on non-statin lipid-lowering therapy or lowest strength dose of statin : ODYSSEY NIPPON |
|
言語 |
en |
| 著者 |
テラモト, タミオ
キヨスエ, アリヒロ
イシガキ, ヤスシ
ハラダ シバ, マリコ
カワバタ, ユミコ
オザキ, アスカ
Baccara-Dinet, Marie T.
佐田, 政隆
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
Background: Alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9, given every 2 weeks (Q2W), significantly reduced low-density lipoprotein cholesterol (LDL-C) levels in Japanese hypercholesterolemic patients on background statin. We evaluated alirocumab 150 mg every 4 weeks (Q4W) in patients on lowest-dose statin or non-statin lipid-lowering therapy (LLT).
Methods: ODYSSEY NIPPON was a double-blind study conducted in Japanese patients with LDL-C≥100 mg/dL (heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia with coronary heart disease) or ≥120 mg/dL (non-familial hypercholesterolemia, Japan Atherosclerosis Society category III) on atorvastatin 5 mg/day or non-statin LLT. Patients were randomized (1:1:1) to subcutaneous alirocumab 150 mg Q4W, alirocumab 150 mg Q2W, or placebo for the 12-week double-blind treatment period (DBTP), followed by a 52-week open-label treatment period (OLTP). At entry into the OLTP, patients received alirocumab 150 mg Q4W, with possible up-titration to 150 mg Q2W at Week 24.
Results: Least-square mean percent change in LDL-C from baseline at Week 12 (primary efficacy endpoint) was -43.8% for alirocumab Q4W, -70.1% for Q2W, and -4.3% for placebo. During the OLTP, mean LDL-C change from baseline was -45.1% at Week 20, with a further reduction at Week 36, with achieved levels maintained to Week 64. Percent of patients with≥1 adverse event (DBTP) was 51.9% with alirocumab Q4W, 47.2% with Q2W, and 46.4% with placebo. Most common adverse events were infections and infestations (25.9%, 22.6%, 17.9%, respectively), gastrointestinal disorders (13.0%, 9.4%, 12.5%), nervous system disorders (5.6%, 7.5%, 10.7%), and general disorders and administration-site conditions (3.7%, 11.3%, 5.4%).
Conclusions: Hypercholesterolemic Japanese patients who tolerate only lowest-strength dose statin or non-statin LLT can achieve robust LDL-C reduction with alirocumab 150 mg Q4W, in addition to their current LLT. Alirocumab 150 mg Q4W dosing was efficacious and generally well tolerated without new safety concerns. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Alirocumab |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Hypercholesterolemia |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Statin |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Cardiovascular risk |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
PCSK9 inhibitor |
| 書誌情報 |
en : Journal of Cardiology
巻 73,
号 3,
p. 218-227,
発行日 2018-11-30
|
| 収録物ID |
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収録物識別子タイプ |
ISSN |
|
収録物識別子 |
09145087 |
| 収録物ID |
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|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AN10070473 |
| 出版者 |
|
|
出版者 |
Elsevier Ltd. |
|
言語 |
en |
| 出版者 |
|
|
出版者 |
Japanese College of Cardiology |
|
言語 |
en |
| 権利情報 |
|
|
言語 |
en |
|
権利情報 |
© 2018 The Authors. ISDN. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
| EID |
|
|
識別子 |
350359 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
joc_73_3_218.pdf (1.06 MB)
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