ID | 115912 |
Title Alternative | EXPERT OPINION ON PHARMACOTHERAPY
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Author |
Odawara, Masato
Tokyo Medical University
Matsuhisa, Munehide
Tokushima University
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Hirose, Takahisa
Toho University
Koshida, Ryusuke
Sanofi K.K.
Senda, Masayuki
Sanofi K.K.
Tanaka, Yasushi
St. Marianna University School of Medicine
Terauchi, Yasuo
Yokohama City University
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Keywords | Diabetes mellitus
Type 2
insulin glargine
product surveillance
postmarketing
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Content Type |
Journal Article
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Description | 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. |
Journal Title |
Expert Opinion on Pharmacotherapy
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ISSN | 14656566
17447666
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NCID | AA11692615
AA12796310
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Publisher | Taylor & Francis
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Volume | 21
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Issue | 14
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Start Page | 1771
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End Page | 1780
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Published Date | 2020-07-22
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Rights | 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.
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language |
eng
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Publisher
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departments |
Institute of Advanced Medical Sciences
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