| アブストラクト | AIMS/INTRODUCTION: This study aimed to investigate the risk of diabetic ketoacidosis (DKA) in insulin-treated type 1 diabetes patients administered sodium-glucose cotransporter 2 (SGLT2) inhibitors in real-world clinical practice. MATERIALS AND METHODS: We carried out a real-world, retrospective, observational cohort study using Japanese Medical Data Vision, a diagnosis procedure combination database. We identified insulin-treated adult type 1 diabetes patients enrolled from December 2018 to October 2019. We assessed the incidence and risk of DKA in type 1 diabetes patients using SGLT2 inhibitors in an 'on-label' manner. Cox multivariate regression analyses were carried out to determine clinical factors linked to SGLT2 inhibitor-associated DKA. RESULTS: Of 11,475 type 1 diabetes patients, 1,898 (16.5%) were prescribed SGLT2 inhibitors. DKA occurred in 139 (7.3%) of these patients, with 20.2 incidences per 100 person-years. These patients also showed significantly higher DKA rates than did those not receiving SGLT2 inhibitors (hazard ratio 1.66, 95% confidence interval 1.33-2.06; P < 0.001). The mean time until DKA onset in SGLT2 inhibitor-treated type 1 diabetes patients was 30.6 +/- 30.1 days. The risk of SGLT2 inhibitor-associated DKA increased in type 1 diabetes patients irrespective of sex, age or body mass index. However, the risk did not increase in type 1 diabetes patients receiving continuous subcutaneous insulin infusion, which warrants further investigation because of the small number of type 1 diabetes patients receiving continuous subcutaneous insulin infusion. CONCLUSIONS: 'On-label' SGLT2 inhibitor use might increase DKA risk among insulin-treated type 1 diabetes patients irrespective of sex, age or body mass index. Both type 1 diabetes patients and healthcare providers should be wary of DKA, especially during the first month of initiating SGLT2 inhibitors. |
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| ジャーナル名 | Journal of diabetes investigation |
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| 投稿日 | 2021/1/16 |
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| 投稿者 | Horii, Takeshi; Oikawa, Yoichi; Atsuda, Koichiro; Shimada, Akira |
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| 組織名 | Laboratory of Pharmacy Practice and Science 1, Division of Clinical Pharmacy,;Research and Education Center for Clinical Pharmacy, Kitasato University School;of Pharmacy, Kanagawa, Japan.;Department of Endocrinology and Diabetes, School of Medicine, Saitama Medical;University, Saitama, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33448127/ |
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