| アブストラクト | AIMS: To investigate the main feature and the association between euglycemic diabetic ketoacidosis (euDKA) /diabetic ketoacidosis (DKA) and sodium-dependent glucose transporters 2 inhibitors (SGLT-2i) from the FDA adverse event reporting system (FAERS). METHODS: Cases of SGLT-2i-associated with euDKA/DKA were extracted from the FAERS database and compared with the reports for other hypoglycemia agents (ATC10 class). Disproportionality analyses used the reporting odds ratio (ROR) and information components (IC). The lower limit of the IC 95% credibility interval for IC > 0 is considered a reported signal, with at least 3 cases. RESULTS: A total of 10,195 cases of euDKA (n = 1680) and DKA (n = 8515) associated with SGLT-2i were identified from the FAERS. The SGLT-2i was associated with higher reporting of euDKA and DKA compared to other hypoglycemia agents (ROR = 16.69 [95% CI 14.89-18.70], IC = 3.27 [95% CI 2.91-3.66] for euDKA; ROR = 16.44 [95% CI 15.72-17.20], IC = 3.19 [95% CI 3.05-3.34] for DKA). In available data, the median onset time of euDKA/DKA was 31 days, and canagliflozin had the longest onset time (96.5 days for euDKA and 75 days for DKA) compared with dapagliflozin and empagliflozin (p < 0.05). Male patients predominate in euDKA (51.9%), and female patients predominate in DKA (53.7%). Most patients discontinue the treatment (95.5% for euDKA, 93.9% for DKA), and approximately 49.0% (n = 3658) of patients had symptomatic remission after discontinuation of SGLT-2i, and 2.3% (n = 173) of patients had no remission. About 75.6% (n = 6126) of patients need hospitalization after euDKA/DKA. CONCLUSIONS: Post-marketing data showed that SGLT-2i was significantly associated with higher reporting of euDKA/DKA. Although euDKA/DKA is rare, clinicians should be aware of SGLT-2i-associated euDKA/DKA events. |
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| ジャーナル名 | Acta diabetologica |
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| 投稿日 | 2022/12/29 |
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| 投稿者 | He, Zhichao; Lam, Kakei; Zhao, Wenxia; Yang, Shan; Li, Yu; Mo, Jiayao; Gao, Siyuan; Liang, Dan; Qiu, Kaifeng; Huang, Min; Wu, Junyan |
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| 組織名 | Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,;107 Yanjiang West Road, Guangzhou, 510120, People's Republic of China.;Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene;Regulation, Guangzhou, People's Republic of China.;School of Pharmaceutical Sciences, Sun Yat-Sen University, 132 Waihuan East Road,;Guangzhou, 511400, People's Republic of China.;qiukf@mail.sysu.edu.cn.;Regulation, Guangzhou, People's Republic of China. qiukf@mail.sysu.edu.cn.;Guangzhou, 511400, People's Republic of China. huangmin@mail.sysu.edu.cn.;wujunyan@mail.sysu.edu.cn.;Regulation, Guangzhou, People's Republic of China. wujunyan@mail.sysu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36576563/ |
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