A real-world data analysis of acetylsalicylic acid in FDA Adverse Event Reporting System (FAERS) database.

IF 3.9 3区医学 Q2 BIOCHEMISTRY & MOLECULAR BIOLOGY Expert Opinion on Drug Metabolism & Toxicology Pub Date : 2023-01-01 Epub Date: 2023-07-12 DOI:10.1080/17425255.2023.2235267

Bin Zhao, Xiaohong Zhang, Moliang Chen, Yan Wang

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Abstract

Background: Acetylsalicylic acid (Aspirin), one of the oldest medicines, is widely used in various clinical fields. However, numerous adverse events (AEs) have been reported. In this study, we aimed to investigate adverse drug reactions (ADRs) of aspirin using real-worlddata from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: We assessed the disproportionality of aspirin-related AEs by calculating measures such as reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagationneural network (BCPNN), and Gamma-Poisson Shrinker (GPS).

Results: Out of 7,510,564 casereports in the FAERS database, 18644 reports of aspirin as the 'primary suspected (PS)' AEs were recorded. Disproportionality analyses identified 493 aspirin-related preferred terms (PTs) across 25 organ systems. Notably, unexpected significant AEs such as pallor (p=5.66E-33), dependence (p=6.45E-67), and compartment syndrome (p=1.95E-28) were observed, which were not mentioned in the drug's instructions.

Conclusion: Our findings align with clinical observations, highlighting potential new and unexpected ADR signals associated with aspirin. Further prospective clinical studies are necessary to confirm and elucidate the relationship between aspirin and these ADRs. This study offers a fresh and unique perspective for studying drug-AEs.

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美国食品药品监督管理局不良事件报告系统（FAERS）数据库中乙酰水杨酸的真实数据分析。

背景：乙酰水杨酸（Aspirin）是最古老的药物之一，广泛应用于各种临床领域。然而，已经报道了许多不良事件（AE）。在本研究中，我们旨在使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的真实数据来调查阿司匹林的不良反应。方法：我们通过计算报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信度传播神经网络（BCPNN）和伽玛-泊松收缩因子（GPS）等指标来评估阿司匹林相关AE的不均衡性。结果：在FAERS数据库中的7510564例病例报告中，记录了18644例阿司匹林为“主要疑似（PS）”AE的报告。不成比例的分析确定了25个器官系统中493个阿司匹林相关的首选术语。值得注意的是，观察到了意想不到的重大AE，如苍白（p=5.66E-33）、依赖性（p=6.45E-67）和隔室综合征（p=1.95E-28），这些在药物说明书中没有提及。结论：我们的研究结果与临床观察结果一致，突出了阿司匹林潜在的新的和意想不到的ADR信号。需要进一步的前瞻性临床研究来证实和阐明阿司匹林与这些不良反应之间的关系。这项研究为研究药物不良反应提供了一个全新而独特的视角。

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

Expert Opinion on Drug Metabolism & Toxicology 医学-生化与分子生物学

CiteScore

7.90

自引率

2.30%

发文量

审稿时长

4-8 weeks

期刊介绍： Expert Opinion on Drug Metabolism & Toxicology (ISSN 1742-5255 [print], 1744-7607 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of ADME-Tox. Each article is structured to incorporate the author’s own expert opinion on the scope for future development. The Editors welcome: Reviews covering metabolic, pharmacokinetic and toxicological issues relating to specific drugs, drug-drug interactions, drug classes or their use in specific populations; issues relating to enzymes involved in the metabolism, disposition and excretion of drugs; techniques involved in the study of drug metabolism and toxicology; novel technologies for obtaining ADME-Tox data. Drug Evaluations reviewing the clinical, toxicological and pharmacokinetic data on a particular drug. The audience consists of scientists and managers in the pharmaceutical industry, pharmacologists, clinical toxicologists and related professionals.