Jie Qiong, Li Yuanyuan, Jing Li, Chen Jinjin, Li Yang
Department of Pharmacy, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Front Pharmacol. 2024 Sep 20;15:1424980. doi: 10.3389/fphar.2024.1424980. eCollection 2024.
The objective of this study is to compare the adverse events (AEs) associated with pralsetinib and selpercatinib.
To evaluate the imbalance of AEs linked to pralsetinib and selpercatinib in real-world data, the reporting odds ratio (ROR) was utilized to detect potential signals of AEs. Stratified analysis was conducted to examine the differences in AEs occurring among different genders and age groups taking pralsetinib and selpercatinib.
FAERS received 891 reports for pralsetinib and 569 reports for selpercatinib. Our analysis confirmed expected AEs like hypertension, fatigue, and elevated transaminase levels. Unexpected AEs such as rhabdomyolysis, myocardial injury and cognitive disorder were associated with pralsetinib, while selpercatinib was linked with pulmonary embolism, deep vein thrombosis, and pericardial effusion. The risk of AEs such as decreased platelet count, anemia, decreased white blood cell count, pneumonitis, asthenia, and edema caused by pralsetinib is significantly higher than that of selpercatinib. In contrast, the risk of AEs such as ascites, elevated alanine aminotransferase, and elevated aspartate aminotransferase caused by selpercatinib is significantly higher than that of pralsetinib. Women treated with pralsetinib experience higher rates of hypertension, pulmonary embolism, and blurred vision than men, who are more susceptible to rhabdomyolysis. Adults between 18 and 65 years are more likely to experience taste disorder, edema, and pulmonary embolism than individuals older than 65, who are particularly vulnerable to hypertension. For patients treated with selpercatinib, males demonstrate a significantly higher incidence of QT prolongation, urinary tract infection, and dysphagia. Individuals aged 18 to 65 are more likely to experience pyrexia and pleural effusion than those older than 65, who are more prone to hypersensitivity.
In the clinical administration of pralsetinib and selpercatinib, it is crucial to monitor the effects of gender and age on AEs and to be vigilant for unlisted AEs.
本研究的目的是比较普拉替尼和塞尔帕替尼相关的不良事件（AE）。
为了评估真实世界数据中与普拉替尼和塞尔帕替尼相关的AE失衡情况，采用报告比值比（ROR）来检测AE的潜在信号。进行分层分析以检查服用普拉替尼和塞尔帕替尼的不同性别和年龄组中发生的AE差异。
美国食品药品监督管理局不良事件报告系统（FAERS）收到了891份关于普拉替尼的报告和569份关于塞尔帕替尼的报告。我们的分析证实了如高血压、疲劳和转氨酶水平升高等预期AE。如横纹肌溶解、心肌损伤和认知障碍等意外AE与普拉替尼有关，而塞尔帕替尼与肺栓塞、深静脉血栓形成和心包积液有关。普拉替尼引起的血小板计数减少、贫血、白细胞计数减少、肺炎、乏力和水肿等AE风险显著高于塞尔帕替尼。相比之下，塞尔帕替尼引起的腹水、丙氨酸转氨酶升高和天冬氨酸转氨酶升高的AE风险显著高于普拉替尼。接受普拉替尼治疗的女性比男性经历高血压、肺栓塞和视力模糊的发生率更高，而男性更容易发生横纹肌溶解。18至65岁的成年人比65岁以上的个体更容易出现味觉障碍、水肿和肺栓塞，65岁以上的个体特别容易患高血压。对于接受塞尔帕替尼治疗的患者，男性QT间期延长、尿路感染和吞咽困难的发生率显著更高。18至65岁的个体比65岁以上的个体更容易出现发热和胸腔积液，65岁以上的个体更容易发生过敏反应。
在普拉替尼和塞尔帕替尼的临床应用中，监测性别和年龄对AE的影响并警惕未列出的AE至关重要。
