Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■Lasmiditan为偏头痛的治疗提供了一个有希望的选择，特别是对于有心血管问题的人。通过大规模的市场后监控，收集Lasmiditan的全面安全信息至关重要。
■本研究根据FDA不良事件报告系统（FAERS）数据库的实际数据评估了lasmiditan的安全性。四种不成比例分析方法被应用于挖掘显著信号。研究了不同亚组之间不良事件信号的差异，涉及种族，性别,年龄,体重,剂量,和伴随的药物。
■共发现820例报告和1,661例不良事件，以lasmiditan为主要可疑药物。出现了两个与神经系统疾病有关的新的不良事件信号。女性和男性更容易出现感觉异常和头晕，分别。大多数常见的不良事件更可能发生在老年患者和高剂量患者中。
■必须警惕潜在的神经系统疾病与lasmiditan的关系。强调了提高对女性感觉异常和男性头晕的临床警惕的重要性。此外,建议老年患者使用较低的初始剂量。
■本研究根据FDA不良事件报告系统（FAERS）数据库的实际数据评估了lasmiditan的安全性。四种不成比例分析方法被应用于挖掘显著信号。研究了不同亚组之间不良事件信号的差异，涉及种族，性别,年龄,体重,剂量,和伴随的药物。
■共发现820例报告和1,661例不良事件，以lasmiditan为主要可疑药物。出现了两个与神经系统疾病有关的新的不良事件信号。女性和男性更容易出现感觉异常和头晕，分别。大多数常见的不良事件更可能发生在老年患者和高剂量患者中。
■必须警惕潜在的神经系统疾病与lasmiditan的关系。强调了提高对女性感觉异常和男性头晕的临床警惕的重要性。此外,建议老年患者使用较低的初始剂量。
