PARP inhibitor-related acute renal failure: a real-world study based on the FDA adverse event reporting system database.

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2024-11-01 Epub Date: 2024-07-08 DOI:10.1080/14740338.2024.2376690
Xiayang Ren, Ping Sun, Yanfeng Wang
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引用次数: 0

Abstract

Background: Current clinical trial data on PARP inhibitors (PARPis)-related acute renal failure (ARF) are not entirely representative of real-world situations. Therefore, in this study, the US Food and Drug Administration Adverse Event Reporting System (FAERS) was used to evaluate PARPis-related ARF.

Research design and methods: Data were obtained from 1 January 2015, to 30 September 2023. ARF event reports were analyzed based on four algorithms. The time-to-onset (TTO) and clinical outcomes of PARPis-associated ARF were assessed.

Results: The total included cases were 2726. Significant signals were observed for olaparib, niraparib, and rucaparib (reporting odds ratio (ROR): 1.62, 95% confidence interval (CI): 1.49-1.78, 1.25, 95% CI: 1.19-1.32 and 1.59, 95% CI: 1.47-1.72 respectively). The median TTO of ARF onset was 57, 36, and 85 days for olaparib, niraparib, and rucaparib, respectively. The proportion of deaths with olaparib (9.88%) was significantly higher than for niraparib (2.52%) and rucaparib (2.94%) (p < 0.005). The proportion of life-threatening adverse events associated with niraparib (4.89%) was significantly higher than for rucaparib (0.98%) (p < 0.005).

Conclusions: ARF and PARPi were related, with the exception of talazoparib. More emphasis should be given to PARPis-related ARF due to the high proportion of serious AEs and delayed adverse reactions.

PARP 抑制剂相关急性肾衰竭:基于 FDA 不良事件报告系统数据库的真实世界研究。
背景:目前关于 PARP 抑制剂(PARPis)相关急性肾衰竭(ARF)的临床试验数据并不能完全代表真实世界的情况。因此,本研究采用美国食品药品管理局不良事件报告系统(FAERS)来评估PARPis相关的ARF:数据采集时间为 2015 年 1 月 1 日至 2023 年 9 月 30 日。ARF事件报告根据四种算法进行分析。评估PARPis相关ARF的发病时间(TTO)和临床结果:结果:共纳入 2726 个病例。观察到奥拉帕利、尼拉帕利和鲁卡帕利出现了显著信号(报告几率比(ROR):1.62,95% 置信区间(CI):1.49-1.781.25,95% CI:1.19-1.32 和 1.59,95% CI:1.47-1.72),它们都出现了 "血肌酐升高 "和 "肾小球滤过率降低 "的阳性信号。奥拉帕利、尼拉帕利和芦卡帕利的ARF发病中位TTO分别为57天、36天和85天。与ARF相关的死亡、危及生命事件和住院不良事件(AEs)的比例分别为4.27%、3.57%和19.80%。奥拉帕利的死亡比例(9.88%)明显高于尼拉帕利(2.52%)和鲁卡帕利(2.94%)(p p 结论):ARF与PARPi有关,但talazoparib除外。肌酐水平升高和肾小球滤过率降低与奥拉帕利、尼拉帕利和芦卡帕利有关。由于 PARPis 相关 ARF 的严重 AE 和延迟不良反应比例较高,因此应更加重视 PARPis 相关 ARF。
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
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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