The First Clinical School of Shandong University of Traditional Chinese Medicine, Jinan, People's Republic of China.
Department of Neurology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, People's Republic of China.
BMC Pharmacol Toxicol. 2024 Sep 27;25(1):71. doi: 10.1186/s40360-024-00790-2.
Tafamidis-associated adverse events (AEs) were investigated retrospectively by data mining the US Food and Drug Administration Adverse Event Reporting System (FAERS) to inform clinical safety.
Data were gathered from the FAERS database, which spans the second quarter of 2019 to the fourth quarter of 2023. A total number of 8532 reports of Tafamidis-related adverse events were detected after evaluating 8,432,351 data. Disproportionality analyses were used to quantify the signal and assess the significance of Tafamidis-associated AEs using four algorithms, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the multi-item gamma Poisson shrinker (MGPS) and the Bayesian confidence propagation neural network (BCPNN).
Among the 8532 reports of AEs with Tafamidis as the primary suspected drug, Tafamidis-induced AEs were identified as occurring in 27 system organ classes (SOC). A total of 207 Tafamidis-induced AEs were detected which simultaneously complied with the four algorithms. Our analysis also identified new adverse reactions including Hypoacusis, Deafness, and Essential hypertension. The median onset of adverse reactions associated with Tafamidis was 180 days (interquartile range [IQR] 51-419 days).
Tafamidis is a drug that has shown favorable safety and tolerability results in clinical trials. However, a number of adverse reactions associated with Tafamidis have been identified through analysis of the FAERS database. In clinical applications, it is recommended to closely monitor patients' hearing while using Tafamidis. In addition, it is hoped that further experimental and clinical studies will be conducted in the future to understand the mechanism of occurrence between Tafamidis and adverse reactions such as primary hypertension, hyperlipidemia, and height reduction.
通过数据挖掘美国食品和药物管理局不良事件报告系统（FAERS），回顾性研究他法米替尼相关不良事件（AEs），以告知临床安全性。
数据来自 FAERS 数据库，涵盖 2019 年第二季度至 2023 年第四季度。在评估了 8432351 份数据后，共检测到 8532 份与他法米替尼相关的不良事件报告。使用包括报告比值比（ROR）、比例报告比（PRR）、多项伽马泊松收缩器（MGPS）和贝叶斯置信传播神经网络（BCPNN）在内的四种算法，进行了不适当性分析，以量化信号并评估他法米替尼相关 AEs 的显著性。
在 8532 份以他法米替尼为主要怀疑药物的不良事件报告中，确定了他法米替尼引起的 AEs 发生在 27 个系统器官类别（SOC）中。共检测到 207 种同时符合四种算法的他法米替尼诱导的 AEs。我们的分析还发现了新的不良反应，包括听力下降、耳聋和原发性高血压。与他法米替尼相关的不良反应的中位发病时间为 180 天（四分位距[IQR]51-419 天）。
他法米替尼在临床试验中表现出良好的安全性和耐受性结果。然而，通过 FAERS 数据库的分析，已经确定了与他法米替尼相关的一些不良反应。在临床应用中，建议在使用他法米替尼时密切监测患者的听力。此外，希望未来能进行进一步的实验和临床研究，以了解他法米替尼与原发性高血压、高血脂和身高降低等不良反应之间的发生机制。
