| アブストラクト | BACKGROUND: Lasmiditan offers a promising option for the treatment of migraines, particularly for individuals with cardiovascular concerns. It is crucial to gather comprehensive safety information of lasmiditan through large-scale post market monitoring. RESEARCH DESIGN AND METHODS: This study assessed the safety profile of lasmiditan based on real-world data of FDA Adverse Event Reporting System (FAERS) database. Four disproportionality analysis methods were applied to mining the significant signals. The differences in adverse event signals among different subgroups were investigated concerning race, sex, age, weight, dose, and concomitant drug. RESULTS: A total of 820 reports and 1,661 adverse events with lasmiditan as the primary suspected drug were identified. Two new adverse event signals related to nervous system disorders emerged. Females and males were more likely to develop paresthesia and dizziness, respectively. Most common adverse events were more likely to occur in the elderly patients and at high doses. CONCLUSIONS: It is essential to be vigilant about the relation of potential nervous system disorders with lasmiditan. The importance of heightened clinical vigilance regarding paresthesia in females and dizziness in males was underscored. Additionally, it is advised to administer a lower initial dose for elderly patients. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/6/20 |
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| 投稿者 | Wan, Xiaochen; Zhang, Shuohan; Jiang, Cheng; Zhang, Hongrui |
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| 組織名 | Department of Clinical Laboratory, Zhejiang Hospital, Hangzhou, Zhejiang, China.;Zhejiang Academy of Traditional Chinese Medicine, Tongde Hospital of Zhejiang;Province, Hangzhou, Zhejiang, China.;School of Basic Medical Sciences and Forensic Medicine, Hangzhou Medical College,;Hangzhou, Zhejiang, China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38898801/ |
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