Reply: [Post-marketing safety concerns with Lecanemab: a disproportionality analysis using the FDA adverse event reporting system].

IF 7.9 1区医学 Q1 CLINICAL NEUROLOGY

Alzheimer's Research & Therapy Pub Date : 2025-04-08 DOI:10.1186/s13195-025-01728-4

Xiaoxuan Xing, Ke Wang, Xianzhe Dong

引用次数: 0

Abstract

In this article, we have carefully read the author's comments on our published article regarding the post-marketing safety concerns of lecanemab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Pharmacovigilance studies based on the disproportionality analysis through the case/non-case design are common, and the details of this method deserve attention. We acknowledged the author's perspectives on the term "signal of disproportionate reporting (SDR)", and make some explanations on the SDR results for pancreatic carcinoma and the deduplication methods.

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回复：[利卡耐单抗上市后的安全问题：使用FDA不良事件报告系统的歧化分析]。

在本文中，我们仔细阅读了作者对我们发表的基于美国食品和药物管理局不良事件报告系统（FAERS）数据库的关于lecanemab上市后安全性问题的文章的评论。通过病例/非病例设计进行歧化分析的药物警戒研究是常见的，该方法的细节值得注意。我们认可了作者对“不成比例报告信号（SDR）”的观点，并对胰腺癌的SDR结果和重复数据删除方法做了一些解释。

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

Alzheimer's Research & Therapy 医学-神经病学

CiteScore

13.10

自引率

3.30%

发文量

172

审稿时长

>12 weeks

期刊介绍： Alzheimer's Research & Therapy is an international peer-reviewed journal that focuses on translational research into Alzheimer's disease and other neurodegenerative diseases. It publishes open-access basic research, clinical trials, drug discovery and development studies, and epidemiologic studies. The journal also includes reviews, viewpoints, commentaries, debates, and reports. All articles published in Alzheimer's Research & Therapy are included in several reputable databases such as CAS, Current contents, DOAJ, Embase, Journal Citation Reports/Science Edition, MEDLINE, PubMed, PubMed Central, Science Citation Index Expanded (Web of Science) and Scopus.