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", "subitem_description_type": "Abstract"}, {"subitem_description": "Research design and methods:\nThis post-marketing surveillance study (STELLA-LONG TERM) included Japanese patients newly initiated on ipragliflozin between 17 July 2014 and 16 October 2015 (data lock: 30 September 2019). Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables. ", "subitem_description_type": "Abstract"}, {"subitem_description": "Results:\nOf 11,424 registered patients, safety and efficacy analysis sets comprised of 11,051 and 8,763 patients, respectively. ADRs occurred in 2,129 patients (19.27%) and serious ADRs occurred in 210 patients (1.90%). Renal and urinary disorders (n = 739, 6.69%), particularly polyuria/pollakiuria (n = 612, 5.54%) and volume depletion-events, including dehydration (n = 243, 2.20%), comprised the most common ADRs. 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Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus : final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM).
http://hdl.handle.net/10422/00012952
http://hdl.handle.net/10422/00012952ea1e54b6-e198-4adb-ab6a-6df154d5d118
Item type | 学術雑誌論文 / Journal Article(1) | |||||
---|---|---|---|---|---|---|
公開日 | 2021-04-16 | |||||
タイトル | ||||||
タイトル | Real-World Evidence for Long-Term Safety and Effectiveness of Ipragliflozin in Japanese Patients with Type 2 Diabetes Mellitus : final Results of a 3-Year Post-Marketing Surveillance Study (STELLA-LONG TERM). | |||||
言語 | ||||||
言語 | eng | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | Ipragliflozin | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | Japan | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | post-marketing surveillance | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | real-world evidence | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | sodium-glucose cotransporter 2 inhibitor | |||||
キーワード | ||||||
言語 | en | |||||
主題Scheme | Other | |||||
主題 | type 2 diabetes mellitus | |||||
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 | |||||
アクセス権 | ||||||
アクセス権 | metadata only access | |||||
アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
著者 |
NAKAMURA, Ichiro
× NAKAMURA, Ichiro× MAEGAWA, Hiroshi× TOBE, Kazuyuki× UNO, Satoshi |
|||||
著者(ヨミ) |
前川, 聡
× 前川, 聡 |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Objective: To evaluate the long-term safety and effectiveness of ipragliflozin in real-world clinical practice in Japanese patients with type 2 diabetes mellitus (T2DM). |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Research design and methods: This post-marketing surveillance study (STELLA-LONG TERM) included Japanese patients newly initiated on ipragliflozin between 17 July 2014 and 16 October 2015 (data lock: 30 September 2019). Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables. |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Results: Of 11,424 registered patients, safety and efficacy analysis sets comprised of 11,051 and 8,763 patients, respectively. ADRs occurred in 2,129 patients (19.27%) and serious ADRs occurred in 210 patients (1.90%). Renal and urinary disorders (n = 739, 6.69%), particularly polyuria/pollakiuria (n = 612, 5.54%) and volume depletion-events, including dehydration (n = 243, 2.20%), comprised the most common ADRs. Mean (SD) change in hemoglobin A1c (─0.66 [1.25] %), fasting plasma glucose (─28.8 [50.1] mg/dL) and body weight (─3.33 [4.32] kg) from baseline to 36 months were statistically significant (P < 0.001). |
|||||
抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Conclusions: The safety profile of long-term ipragliflozin treatment in routine clinical practice is consistent with previously reported interim data at 12 or 24 months and pre-approval clinical trials. Ipragliflozin treatment was also associated with sustained improvements in efficacy parameters for over 3 years. |
|||||
書誌情報 |
en : Expert opinion on pharmacotherapy 巻 22, 号 3, p. 373-387, 発行日 2021-02 |
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出版者 | ||||||
出版者 | Springer Japan | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 1744-7666 | |||||
PMID | ||||||
識別子タイプ | PMID | |||||
関連識別子 | 33012212 | |||||
DOI | ||||||
識別子タイプ | DOI | |||||
関連識別子 | https://doi.org/10.1080/14656566.2020.1817388 | |||||
関連名称 | 10.1080/14656566.2020.1817388 | |||||
資源タイプ | ||||||
内容記述タイプ | Other | |||||
内容記述 | Journal Article |