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Abstract：
With its increasing use in the treatment of thrombocytopenia, avatrombopag\'s associated adverse events (AEs) pose a major challenge to its clinical application. This study aims to comprehensively study AEs associated with avatrombopag by using real-world evidence. We curated AE reports for avatrombopag from the first quarter of 2018 to the fourth quarter of 2023 in the US Food and Drug Administration\'s Adverse Event Reporting System (FAERS) database. AEs were coded using the Medical Dictionary for Regulatory Activities of Preferred Terms and System Organ Classes. The reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item Gamma-Poisson Shrinker were used to investigate the relationship between avatrombopag and AE reports. Among 9,060,312 reported cases in the FAERS database, 1211 reports listed avatrombopag as \"primary suspected\" drug. Disproportionality analysis identified 44 preferred terms across 17 organ systems met the criteria for at least one of the four algorithms. The most commonly reported AEs were platelet count decreased (20.2%), headache (16.7%), platelet count increased (11.9%), platelet count abnormal (6.3%), contusion (2.7%), pulmonary embolism (2.3%), and deep vein thrombosis (2.1%). Unexpected AEs such as seasonal allergy, rhinorrhea, antiphospholipid syndrome, ear discomfort, and photopsia were also observed. Excluding the other serious outcomes, hospitalization (34.6%) was the most frequently reported serious outcome, followed by death (15.4%). Most reported AEs occurred within the first 2 days of initiating avatrombopag therapy, and the median onset time was 60 days. We identified new and unexpected AEs with clinical use of avatrombopag, and our results may provide valuable information for clinical monitoring and identifying risks associated with avatrombopag.
摘要：
随着其在血小板减少症治疗中的应用越来越多,avatrombopag的相关不良事件（AE）对其临床应用提出了重大挑战。本研究旨在通过使用真实世界的证据来全面研究与avatrombopag相关的AE。我们在美国食品和药物管理局的不良事件报告系统（FAERS）数据库中策划了从2018年第一季度到2023年第四季度的avatrombopag的AE报告。使用用于首选术语和系统器官类别的监管活动的医学词典对AE进行编码。报告的赔率比，比例报告比率，贝叶斯置信度传播神经网络，和多项目Gamma-PoissonShrinker用于研究avatrombopag与AE报告之间的关系。在FAERS数据库中的9,060,312例报告病例中，1211份报告将avatrombopag列为“主要可疑”药物。不相称性分析确定了17个器官系统中的44个首选项符合四种算法中至少一种的标准。最常报告的不良事件是血小板计数减少（20.2%），头痛（16.7%），血小板计数增加（11.9%），血小板计数异常（6.3%），挫伤（2.7%），肺栓塞(2.3%),深静脉血栓形成(2.1%)。意外的不良事件，如季节性过敏，鼻漏,抗磷脂综合征,耳朵不适,并且还观察到了光视。排除其他严重后果，住院（34.6%）是最常见的严重结局，其次是死亡（15.4%）。大多数报告的不良事件发生在开始avatrombopag治疗的前2天内，中位发病时间为60天。我们通过临床使用avatrombopag确定了新的和意外的AE，我们的结果可能为临床监测和识别与avatrombopag相关的风险提供有价值的信息。
