| Item type |
文献 / Documents(1) |
| 公開日 |
2021-07-30 |
| 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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識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.1080/14656566.2020.1785430 |
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言語 |
ja |
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関連名称 |
10.1080/14656566.2020.1785430 |
| 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 |
Effectiveness and safety of insulin glargine 300 unit/mL in Japanese type 2 diabetes mellitus patients : a 12-month post-marketing surveillance study (X-STAR study) |
|
言語 |
en |
| タイトル別表記 |
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その他のタイトル |
EXPERT OPINION ON PHARMACOTHERAPY |
|
言語 |
en |
| 著者 |
オダワラ, マサト
松久, 宗英
ヒロセ, タカヒサ
コシダ, リュウスケ
センダ, マサユキ
タナカ, ヤスシ
テラウチ, ヤスオ
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| 抄録 |
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内容記述タイプ |
Abstract |
|
内容記述 |
Background: With limited real-world insulin glargine 300 unit/mL (Gla-300) data available, we assessed the effectiveness and safety of Gla-300 in the Japanese type 2 diabetes mellitus (T2DM) population.
Research design and methods: X-STAR was a prospective, observational, 12-month post-marketing study of Gla-300 from 2015 to 2018. T2DM patients received Gla-300 as the first insulin (insulin-naïve) or after treatment with another type of insulin (insulin-experienced).
Results: We identified 1,227 insulin-naïve and 3,394 insulin-experienced patients. Insulin-naïve group increased the Gla-300 starting dose by 2.80 U/day during 12 months (7.49 to 10.29 U/day). Mean HbA1c reduced by 1.99% (9.82 to 7.83%), and 28.4% showed HbA1c < 7.0%. Insulin-experienced group had a baseline insulin dose of 14.86 U/day, which increased by 0.73 U/day. Mean HbA1c reduced by 0.18% (7.99 to 7.81%), and 24.6% showed HbA1c < 7.0%. Adverse drug reactions occurred in 3.42% (insulin-naïve) and 4.45% (insulin-experienced); symptomatic hypoglycemia (2.93% and 3.86%, respectively) was the most common in both groups.
Conclusions: Gla-300, in clinical practice, provides an effective and safe therapy as HbA1c was reduced/maintained in insulin-naïve/experienced Japanese T2DM patients without new safety signal. This study provides insights into the current Japanese clinical practices where insulin use is delayed and conservative despite relatively low HbA1c achievement. |
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言語 |
en |
| キーワード |
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言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Diabetes mellitus |
| キーワード |
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言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Type 2 |
| キーワード |
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言語 |
en |
|
主題Scheme |
Other |
|
主題 |
insulin glargine |
| キーワード |
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|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
product surveillance |
| キーワード |
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|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
postmarketing |
| 書誌情報 |
en : Expert Opinion on Pharmacotherapy
巻 21,
号 14,
p. 1771-1780,
発行日 2020-07-22
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| 収録物ID |
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収録物識別子タイプ |
ISSN |
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収録物識別子 |
14656566 |
| 収録物ID |
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収録物識別子タイプ |
ISSN |
|
収録物識別子 |
17447666 |
| 収録物ID |
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|
収録物識別子タイプ |
NCID |
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収録物識別子 |
AA11692615 |
| 収録物ID |
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収録物識別子タイプ |
NCID |
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収録物識別子 |
AA12796310 |
| 出版者 |
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出版者 |
Taylor & Francis |
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言語 |
en |
| 権利情報 |
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|
言語 |
en |
|
権利情報 |
This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. |
| EID |
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識別子 |
367598 |
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識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
eop_21_14_1771.pdf (893 KB)
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