免疫检查点抑制剂房颤报告频率的药物警戒研究:来自FDA不良事件报告系统的见解。

IF 3.4 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Therapeutic Advances in Drug Safety Pub Date : 2025-04-21 eCollection Date: 2025-01-01 DOI:10.1177/20420986241312497
Nunzia Balzano, Annamaria Mascolo, Donatella Ruggiero, Concetta Rafaniello, Giuseppe Paolisso, Francesco Rossi, Annalisa Capuano
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引用次数: 0

摘要

背景:免疫检查点抑制剂(ICIs)已经改变了癌症治疗,但与免疫相关不良事件(irAEs)相关,包括心脏事件。目的:本研究旨在利用美国食品和药物管理局不良事件报告系统(FAERS)的数据评估ICIs心房颤动的报告频率。设计:这是一项观察性、回顾性、药物警戒性研究。方法:检索截至2024年9月24日的FAERS病例安全报告(ICSRs)。报告一种或多种ICIs (atezolizumab、avelumab、cemiplimab、dostarlimumab、durvalumab、ipilimumab、nivolumab、pembrolizumab和tremelimumab)和房颤的病例被选中。歧化分析采用报告优势比(ROR)和95%置信区间(95% CI)的信息成分(IC)进行。结果:共检索到1228例icsr,其中218例(17.75%)与icrs联合相关。大多数icsr (N = 812;66.1%)涉及男性患者,最具代表性的年龄组是大于或等于65岁(N = 772;62.9%)。房颤严重发生率为99.3% (N = 1220),死亡发生率为248;20.3%)。与所有其他药物相比,Atezolizumab、avelumab、durvalumab、nivolumab和pembrolizumab与房颤报告频率的统计学显著性升高相关(ROR: 1.90, IC: 0.91;Ror: 1.94, ic: 0.92;Ror: 1.52, ic: 0.60;Ror: 1.30, ic: 0.38;ROR: 1.66, IC: 0.72)。与所有其他药物(ROR: 0.69, IC: -0.53)和所有其他ICIs (ROR: 0.45, IC: -1.02)相比,抗ctla -4易匹单抗的房颤报告频率具有统计学意义。此外,与抗ctla -4相比,抗pd - l1 (ROR: 2.60, IC: 0.47)和抗pd -1 (ROR: 2.12, IC: 0.16)与更高的房颤报告相关。结论:ci诱发心房颤动严重,预后严重。抗ctla -4报告心房颤动的可能性较低,而抗pd -1和抗pd - l1报告心房颤动的可能性较高。需要进一步的研究来证实这种安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacovigilance study on the reporting frequency of atrial fibrillation with immune checkpoint inhibitors: insights from FDA Adverse Event Reporting System.

Background: Immune checkpoint inhibitors (ICIs) have transformed cancer therapy but are linked with immune-related adverse events (irAEs), including cardiac events.

Objective: This study aims to assess the reporting frequency of atrial fibrillation with ICIs using data from the Food and Drug Administration Adverse Event Reporting System (FAERS).

Design: It is an observational, retrospective, pharmacovigilance study.

Methods: Individual Case Safety Reports (ICSRs) were retrieved from FAERS up to September 24, 2024. Cases reporting one or more ICIs (atezolizumab, avelumab, cemiplimab, dostarlimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and tremelimumab) and atrial fibrillation were selected. Disproportionality analyses were performed by applying the reporting odds ratio (ROR) and the Informational Component (IC) with a 95% confidence interval (95% CI).

Results: A total of 1228 ICSRs were retrieved, of which 218 (17.75%) were related to combinations of ICIs. Most ICSRs (N = 812; 66.1%) referred to male patients and the age group most represented was ⩾65 years (N = 772; 62.9%). Atrial fibrillation was serious in 99.3% (N = 1220) of cases and had a fatal outcome (N = 248; 20.3%). Atezolizumab, avelumab, durvalumab, nivolumab, and pembrolizumab were associated with a statistically significant higher reporting frequency of atrial fibrillation compared to all other drugs (ROR: 1.90, IC: 0.91; ROR: 1.94, IC: 0.92; ROR: 1.52, IC: 0.60; ROR: 1.30, IC: 0.38; ROR: 1.66, IC: 0.72, respectively). The anti-CTLA-4 ipilimumab showed a statistically significant lower reporting frequency of atrial fibrillation compared to all other drugs (ROR: 0.69, IC: -0.53) and to all other ICIs (ROR: 0.45, IC: -1.02). Moreover, anti-PD-L1 (ROR: 2.60, IC: 0.47) and anti-PD-1 (ROR: 2.12, IC: 0.16) were associated with a higher reporting of atrial fibrillation compared to anti-CTLA-4.

Conclusion: ICI-induced atrial fibrillation was serious and had severe outcomes. The anti-CTLA-4 showed a lower likelihood of reporting atrial fibrillation, while higher reporting was found with anti-PD-1 and anti-PD-L1. Further studies are needed to confirm this safety aspect.

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来源期刊
Therapeutic Advances in Drug Safety
Therapeutic Advances in Drug Safety Medicine-Pharmacology (medical)
CiteScore
6.70
自引率
4.50%
发文量
31
审稿时长
9 weeks
期刊介绍: Therapeutic Advances in Drug Safety delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies pertaining to the safe use of drugs in patients. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in drug safety, providing a forum in print and online for publishing the highest quality articles in this area. The editors welcome articles of current interest on research across all areas of drug safety, including therapeutic drug monitoring, pharmacoepidemiology, adverse drug reactions, drug interactions, pharmacokinetics, pharmacovigilance, medication/prescribing errors, risk management, ethics and regulation.
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