| Item type |
文献 / Documents(1) |
| 公開日 |
2021-12-22 |
| 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/10.1080/14656566.2020.1810665 |
|
|
言語 |
ja |
|
|
関連名称 |
10.1080/14656566.2020.1810665 |
| 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 |
Real-world data on the use of insulin glargine 300 U/mL in Japanese patients with type 1 diabetes : twelve-month results from a post-marketing surveillance study (X-STAR study) |
|
言語 |
en |
| 著者 |
松久, 宗英
オダワラ, マサト
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
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
Background: With limited real-world insulin glargine 300 U/mL (Gla-300) data among Japanese patients with type 1 diabetes mellitus (T1DM) available, the authors describe its effectiveness and safety in Japanese T1DM patients switching to Gla-300.
Research design and methods: X-STAR was a 12-month prospective, observational, post-marketing study in Japanese patients with diabetes mellitus from 2015 to 2018: insulin-experienced T1DM patients initiating Gla-300 were analyzed.
Results: Of 774 patients, mean (±standard deviation) HbA1c (%) and fasting plasma glucose (mg/dL) decreased from 8.27 ± 1.55 to 8.15 ± 1.35 (by −0.12 ± 1.30 [p = 0.013]) and 167.9 ± 92.6 to 153.9 ± 70.9 (by −13.9 ± 103.8 [p = 0.067]) from baseline to month 12, respectively. A total of 16.3% achieved HbA1c <7.0% at month 12. Gla-300 dose increased by 1.13 ± 3.18 U/day (0.02 ± 0.05 U/kg/day) (p < 0.001), with a + 0.22 ± 2.70 (p = 0.037) body-weight change (kg) from baseline 60.83 ± 12.81 to 12-month 61.06 ± 12.89. Adverse drug reactions (ADRs) and serious ADRs occurred in 9.82% and 0.78% of the patients, respectively. Hypoglycemia was the most common ADR (9.30%). In total, 88.9% adhered to Gla-300 administration schedules, whereas <40% adhered to exercise and dietary instructions, respectively.
Conclusions: Gla-300 showed no unprecedented safety concerns for insulin-experienced T1DM patients in Japanese clinical settings. Our results provide insights into strategies for blunted Gla-300 up-titration dose, despite insufficient HbA1c control and lifestyle modification. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Basal insulin |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Japanese |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
post-marketing surveillance study |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
type 1 diabetes mellitus |
| 書誌情報 |
en : Expert Opinion on Pharmacotherapy
巻 22,
号 2,
p. 249-256,
発行日 2020-08-25
|
| 収録物ID |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
14656566 |
| 収録物ID |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
17447666 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA11692615 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA12796310 |
| 出版者 |
|
|
出版者 |
Taylor & Francis |
|
言語 |
en |
| 権利情報 |
|
|
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 |
|
|
識別子 |
376758 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
eop_22_2_249.pdf (836 KB)
.png)
