Song Qi, Gao Siyuan, Tan Yaqian
Department of Pharmacy, Guangzhou Institute of Cancer Research, The Affiliated Cancer Hospital, Guangzhou Medical University, Guangzhou, China.
Department of Pharmacy, Guangdong Province Hospital for Occupational Disease Prevention and Treatment, Guangzhou, China.
J Headache Pain. 2025 Jun 23;26(1):147. doi: 10.1186/s10194-025-02091-3.
BACKGROUND: Gepants have demonstrated notable benefits in migraine therapy, yet their safety profiles are not thoroughly investigated. This study comprehensively analyzed the adverse event (AE) risk signals of the currently approved gepants using the U.S. Food and Drug Administration Adverse Event Reporting System database, aiming to gain better understanding of their post-marketing safety features and potential risks. METHODS: All data of the gepants (rimegepant, atogepant, ubrogepant, and zavegepant) from January 1st 2020 to December 31st 2024 were retrieved from the database. Descriptive analysis was conducted to characterize the features of gepant-associated AEs. Disproportionality analysis and subsequent sensitivity analysis were employed to evaluate the risk signals of the gepants utilizing the algorithms of reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC). RESULTS: A total of 7766 reports of rimegepant, 3672 reports of atogepant, 1958 reports of ubrogepant, and 463 reports of zavegepant were identified after data processing. Most AEs were occurred within 30 days after gepant administration. The integration of disproportionality analysis and sensitivity analysis indicated that "feeling abnormal" was the most reported AE of rimegepant (n = 185, 6.81%, ROR = 6.46, IC = 2.59, PRR = 7.24, χ = 998.58), while "constipation" was the most common AE of atogepant (n = 288, 16.09%, ROR = 19.99, IC = 4.10, PRR = 20.72, χ = 5418.12). The most prevalent AE of ubrogepant was "fatigue" (n = 60, 7.19%, ROR = 1.88, IC = 0.84, PRR = 2.38, χ = 48.82), whereas "dysgeusia" was the most frequently observed AE of zavegepant (n = 150, 45.18%, ROR = 212.07, IC = 6.10, PRR = 181.96, χ = 26,975.74). Comparative analysis of AEs revealed that two AEs were shared among all gepants and zavegepant had the largest collection of unique AEs (n = 15). CONCLUSIONS: The present pharmacovigilance study systematically revealed the significant risk signals of gepants. The common AEs and unique AEs of the four gepants were also identified and explored. Our results would provide valuable reference for the safe use of gepants, guiding personalized drug selection in clinical practice.
背景： gepants类药物在偏头痛治疗中已显示出显著疗效，但其安全性尚未得到充分研究。本研究利用美国食品药品监督管理局不良事件报告系统数据库，全面分析了目前已获批的gepants类药物的不良事件（AE）风险信号，旨在更好地了解其上市后安全性特征和潜在风险。 方法： 从数据库中检索2020年1月1日至2024年12月31日期间gepants类药物（瑞美吉泮、阿托吉泮、乌布吉泮和扎韦吉泮）的所有数据。进行描述性分析以表征gepants类药物相关AE的特征。采用不成比例分析及后续敏感性分析，运用报告比值比（ROR）、比例报告比（PRR）和信息成分（IC）算法评估gepants类药物的风险信号。 结果： 数据处理后，共识别出7766份瑞美吉泮报告、3672份阿托吉泮报告、1958份乌布吉泮报告和463份扎韦吉泮报告。大多数AE发生在服用gepants类药物后30天内。不成比例分析与敏感性分析相结合表明，“感觉异常”是瑞美吉泮报告最多的AE（n = 185，6.81%，ROR = 6.46，IC = 2.59，PRR = 7.24，χ = 998.58），而“便秘”是阿托吉泮最常见的AE（n = 288，16.09%，ROR = 19.99，IC = 4.10，PRR = 20.72，χ = 5418.12）。乌布吉泮最常见的AE是“疲劳”（n = 60，7.19%，ROR = 1.88，IC = 0.84，PRR = 2.38，χ = 48.82），而“味觉障碍”是扎韦吉泮最常观察到的AE（n = 150，45.18%，ROR = 212.07，IC = 6.10，PRR = 181.96，χ = 26,975.74）。AE的比较分析显示，所有gepants类药物中有两种AE是共有的，扎韦吉泮具有最多的独特AE（n = 15）。 结论： 本药物警戒研究系统地揭示了gepants类药物的显著风险信号。还识别并探讨了四种gepants类药物的常见AE和独特AE。我们的结果将为gepants类药物的安全使用提供有价值的参考，指导临床实践中的个性化药物选择。
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