| アブストラクト | BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are effective in reducing the risk of heart failure (HF) in type 2 diabetic patients. We systematically examined the association between cardiac adverse events (CAEs) and SGLT2i. RESEARCH DESIGN AND METHODS: We analyzed CAEs in the FDA Adverse Event Reporting System between January 2013 and March 2021. The CAEs were classified into four major groups according to their preferred terms. Disproportionality and Bayesian analyses were performed to detect signals using reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayesian geometric mean (EBGM). Case seriousness was also described. RESULTS: There were 2,330 CAEs associated with SGLT2i, and 81 were used for HFs. The SGLT2i were not associated with over-reporting frequencies of CAE based on ROR (ROR = 0.97, 95% confidence interval [CI]: 0.93, 1.01), PRR (PRR = 0.97, 95% CI: 0.94, 1.01), Bayesian confidence propagation neural network (IC = -0.04, IC025: N.A.), and multi-item gamma Poisson shrinker (EBGM = 0.97, EBGM05:0.94), unless further restricted to myocardial infarction (ROR = 2.03, 95% CI = 1.89, 2.17). Additionally, SGLT2i-associated CAEs are associated with 11.33% fatality and 51.25% hospitalization. CONCLUSIONS: SGLT2i present a favorable cardiac safety profile; however, concerns should be raised regarding their potential association with specific events. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2023/5/19 |
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| 投稿者 | Zhang, Lei; Pan, Chen; Yang, Xinyu; Jiang, Dechun; Cao, Mingnan |
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| 組織名 | Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical University,;Beijing, China.;Beijing Key Laboratory of Bio-characteristic Profiling for Evaluation of Rational;Drug Use, Beijing, China.;Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University,;Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/37203199/ |
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