Adverse Reactions With VEGF Inhibitors in Combination With NSAIDs: Disproportionality Analysis Using JADRE and FAERS.

IF 1.8 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

In vivo Pub Date : 2025-05-01 DOI:10.21873/invivo.13947

Kazuki Saito, Satoru Nihei, Junichi Asaka, Kenzo Kudo

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引用次数: 0

Abstract

Background/aim: The concurrent use of vascular endothelial growth factor (VEGF) inhibitors and nonsteroidal anti-inflammatory drugs (NSAIDs) raises concerns regarding the increased risk of adverse drug reactions (ADRs) due to potential pharmacodynamic interactions. However, no studies have specifically addressed this issue. The objective of this study was to investigate whether the combination of these drugs increased the risk of ADRs.

Patients and methods: Disproportionality analysis was conducted on ADR reports from the Japanese Adverse Drug Event Report (JADER) and FDA Adverse Event Reporting System (FAERS) databases. The concomitant signal score and Ω shrinkage measure were used to identify safety signals associated with the drug combination. Additionally, logistic regression analysis focused on reports of ADRs related to cancer treatment and assessed the significance of the adjusted reporting odds ratio (aROR) for the interaction between these drugs.

Results: Disproportionality analysis included ADR data from the JADER (n=1,509,399) and FAERS (n=38,610,433) databases. The concomitant signal score and Ω shrinkage measure identified a signal for gastrointestinal perforation in both databases. Logistic regression on cancer treatment-related ADRs (JADER: n=255,177; FAERS: n=1,167,941) showed a synergistic increase in gastrointestinal perforation risk with the drug combination [aROR for interaction term: JADER: 1.74 (95% confidence interval (CI)=1.45-2.07); FAERS: 1.49 (95% CI=1.29-1.72)].

Conclusion: The combination of VEGF inhibitors and NSAIDs is associated with an increased risk of gastrointestinal perforation, a serious and potentially fatal ADR. Therefore, caution is warranted when prescribing a combination of these drugs.

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VEGF抑制剂联合非甾体抗炎药的不良反应：使用JADRE和FAERS进行歧化分析。

背景/目的：血管内皮生长因子（VEGF）抑制剂和非甾体抗炎药（NSAIDs）同时使用，由于潜在的药效学相互作用，引起了对药物不良反应（adr）风险增加的担忧。然而，没有研究专门针对这个问题。本研究的目的是调查这些药物的联合使用是否会增加不良反应的风险。患者和方法：对来自日本药品不良事件报告（JADER）和FDA不良事件报告系统（FAERS）数据库的ADR报告进行歧化分析。使用伴随信号评分和Ω收缩测量来识别与药物联合相关的安全信号。此外，logistic回归分析侧重于与癌症治疗相关的不良反应报告，并评估这些药物之间相互作用的调整报告优势比（aROR）的意义。结果：歧化分析包括来自JADER （n=1,509,399）和FAERS （n=38,610,433）数据库的ADR数据。伴随的信号评分和Ω收缩测量在两个数据库中确定了胃肠道穿孔的信号。癌症治疗相关不良反应的Logistic回归分析(JADER: n=255,177；FAERS: n=1,167,941)显示胃肠道穿孔风险与药物联合增效增加[相互作用项的aROR: JADER: 1.74(95%可信区间(CI)=1.45-2.07)；误差：1.49 (95% ci =1.29-1.72)]。结论：VEGF抑制剂联合非甾体抗炎药与胃肠道穿孔的风险增加有关，这是一种严重且可能致命的不良反应。因此，在处方这些药物的组合时要谨慎。

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

In vivo 医学-医学：研究与实验

CiteScore

4.20

自引率

4.30%

发文量

330

审稿时长

3-8 weeks

期刊介绍： IN VIVO is an international peer-reviewed journal designed to bring together original high quality works and reviews on experimental and clinical biomedical research within the frames of physiology, pathology and disease management. The topics of IN VIVO include: 1. Experimental development and application of new diagnostic and therapeutic procedures; 2. Pharmacological and toxicological evaluation of new drugs, drug combinations and drug delivery systems; 3. Clinical trials; 4. Development and characterization of models of biomedical research; 5. Cancer diagnosis and treatment; 6. Immunotherapy and vaccines; 7. Radiotherapy, Imaging; 8. Tissue engineering, Regenerative medicine; 9. Carcinogenesis.