Zhang Ying, Sun Shengzhu, Wang Yuming
First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, PR China.
Department of Otolaryngology, Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan, Shandong, PR China.
Expert Opin Drug Saf. 2024 Sep 12:1-7. doi: 10.1080/14740338.2024.2393268.
Migraine, a prevalent neurovascular disorder, can significantly disrupt an individual's daily life. Atogepant (AGN-241689), an orally administered small-molecule drug classified as a calcitonin gene-related peptide receptor antagonist, is utilized for prophylactic migraine treatment. The objective of this study was to investigate adverse events (AEs) associated with atogepant through data mining in the FDA Adverse Event Reporting System (FAERS) to enhance clinical safety.
Data for atogepant were obtained from the FAERS database covering Q3 2021 through Q4 2023. Disproportionality analysis was employed to quantify relevant AEs associated with atogepant. Reported Ratio of Ratios (ROR) was utilized for identifying risk signals within the FAERS data. This methodology relies on the System Organ Class (SOC) and Preferred Terminology (PT) of the Medical Dictionary for Regulatory Activities (MedDRA).
From the FAERS database, a collection of 7,991,243 reports was obtained. Among these reports, a subset of 3015 was identified as 'primary suspected (PS)' AEs specifically related to atogepant. AEs induced by atogepant were observed across 27 organ systems. A total of 48 significantly disproportionate Preferred Terminologies (PTs) meeting all four algorithms were identified.
Our study has identified adverse events (AEs) associated with atogepant, potentially providing crucial support for the clinical monitoring and risk identification of atogepant.
偏头痛是一种常见的神经血管疾病，会严重扰乱个人日常生活。阿托格潘（AGN-241689）是一种口服小分子药物，属于降钙素基因相关肽受体拮抗剂，用于偏头痛的预防性治疗。本研究的目的是通过美国食品药品监督管理局不良事件报告系统（FAERS）中的数据挖掘来调查与阿托格潘相关的不良事件（AE），以提高临床安全性。
从涵盖2021年第三季度至2023年第四季度的FAERS数据库中获取阿托格潘的数据。采用不成比例分析来量化与阿托格潘相关的相关AE。报告比值比（ROR）用于识别FAERS数据中的风险信号。该方法依赖于监管活动医学词典（MedDRA）的系统器官分类（SOC）和首选术语（PT）。
从FAERS数据库中获得了7991243份报告。在这些报告中，有3015份被确定为与阿托格潘特别相关的“主要疑似（PS）”AE。在27个器官系统中观察到了阿托格潘引起的AE。总共确定了48个符合所有四种算法的显著不成比例的首选术语（PT）。
我们的研究确定了与阿托格潘相关的不良事件（AE），可能为阿托格潘的临床监测和风险识别提供关键支持。
