Pembrolizumab-Associated Cardiotoxicity: A Retrospective Analysis of the FDA Adverse Events Reporting System.

IF 4.3 3区医学 Q2 CHEMISTRY, MEDICINAL

Pharmaceuticals Pub Date : 2024-10-15 DOI:10.3390/ph17101372

Stefan Milutinovic, Predrag Jancic, Vera Jokic, Marija Petrovic, Igor Dumic, Ambar Morales Rodriguez, Nikola Tanasijevic, Dustin Begosh-Mayne, Dragana Stanojevic, Ricardo O Escarcega, Juan Lopez-Mattei, Xiangkun Cao

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引用次数: 0

Abstract

Background: Immune checkpoint inhibitors (ICIs) have been successfully used in the previous decade for the treatment of a variety of malignancies. Adverse events (AEs) can cause many symptoms, most notably cardiac. We analyzed the frequency of these adverse events, comparing pembrolizumab and other ICIs.

Methods: Using the Food and Drug Administration (FDA) adverse event reporting database (FAERS), we searched for all adverse events of interest reported for every ICI included in this study. After obtaining the data, we conducted a disproportionality analysis using the reporting odds ratio (ROR) and the information component (IC).

Results: A total of 6719 ICI-related cardiac adverse events of interest were reported in the database. Serious outcomes were reported in 100% of the cases, with 34.3% of the cases ending fatally. Compared with all other medications in the database, pembrolizumab use was more frequently associated with myocarditis, pericardial disease, heart failure, and atrial fibrillation. No difference was found in cardiotoxicity between different ICIs.

Conclusions: Although infrequent, cardiac AEs in pembrolizumab use are associated with serious outcomes and high mortality. Prospective studies are needed to further research the connection between ICI use and cardiotoxicity.

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与 Pembrolizumab 相关的心脏毒性：对 FDA 不良事件报告系统的回顾性分析。

背景：免疫检查点抑制剂（ICIs）在过去十年中已成功用于治疗多种恶性肿瘤。不良事件（AEs）可导致多种症状，最明显的是心脏症状。我们分析了这些不良事件的发生频率，并对彭博利珠单抗和其他 ICIs 进行了比较：我们使用食品药品管理局 (FDA) 的不良事件报告数据库 (FAERS)，搜索了本研究中每种 ICI 报告的所有相关不良事件。获得数据后，我们使用报告几率比（ROR）和信息成分（IC）进行了比例失调分析：结果：数据库中共报告了 6 719 例 ICI 相关的心脏不良事件。100%的病例报告了严重后果，其中34.3%的病例以死亡告终。与数据库中的所有其他药物相比，使用 pembrolizumab 更常引发心肌炎、心包疾病、心力衰竭和心房颤动。不同的 ICIs 在心脏毒性方面没有差异：结论：使用pembrolizumab时，心脏AE虽然不常见，但与严重后果和高死亡率有关。需要开展前瞻性研究，进一步研究 ICI 的使用与心脏毒性之间的联系。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceuticals Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science

CiteScore

6.10

自引率

4.30%

发文量

1332

审稿时长

6 weeks

期刊介绍： Pharmaceuticals (ISSN 1424-8247) is an international scientific journal of medicinal chemistry and related drug sciences.Our aim is to publish updated reviews as well as research articles with comprehensive theoretical and experimental details. Short communications are also accepted; therefore, there is no restriction on the maximum length of the papers.