| アブストラクト | Lacosamide was the first approved third-generation antiepileptic drug. However, real-world data regarding its adverse cardiac reactions in large samples still need to be completed. We evaluated the cardiac safety profile of lacosamide using the Food and Drug Administration Adverse Event Reporting System (FAERS). We performed disproportionality analysis computing reporting odds ratio (ROR) as a quantitative metric to assess the signal of lacosamide-related cardiac adverse events (AEs) from 2013 Q1 to 2022 Q4. The signal was considered significant when the lower limit of the 95% confidence interval (CI) of the ROR exceeded 1, and >/= 5 AEs were reported. Serious and nonserious cases were compared by statistical analysis, and signals were further prioritized using a rating scale. A total of 812 cardiac AEs associated with lacosamide were identified, and 92 signals were detected, of which 17 AEs were significantly associated signals. The median time-to-onset (TTO) for moderate priority signals was 10 days, whereas for weak priority signals, it was 54 days. Notably, all cardiac AEs exhibited an early failing pattern, indicating the risk gradually decreasing. Based on the comprehensive analysis of the FAERS database and prioritization of cardiac AE signals, our research enhances the awareness among healthcare professionals regarding cardiac AEs associated with lacosamide. |
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| ジャーナル名 | Scientific reports |
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| 投稿日 | 2024/7/14 |
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| 投稿者 | Yang, Chengcheng; Zhao, Wanqi; Chen, Huihui; Yao, Yinhui; Zhang, Jingmin |
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| 組織名 | Department of Pharmacy, The First People's Hospital of Shangqiu, Shangqiu,;476000, China. ycc424@163.com.;The University of Manchester, Manchester, M13 9PL, England.;476000, China.;Department of Pharmacy, Chengde Medical University Affiliated Hospital, Chengde,;067000, China.;Department of Pharmacy, Henan Key Laboratory for Precision Clinical Pharmacy, The;First Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.;fcczhangjm@zzu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39003359/ |
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