{"title":"Pharmacovigilance analysis of small bowel bleeding associated with NSAIDs.","authors":"Ying-Han Deng, Meiting Jiang, Yun Chen, Hong-Bin Chen","doi":"10.1177/20420986251318848","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Currently, the factors influencing small bowel bleeding caused by nonsteroidal anti-inflammatory drugs (NSAIDs) remain unclear.</p><p><strong>Objectives: </strong>This study aimed to assess NSAID-associated small bowel bleeding and evaluate the impact of other drugs on it through a pharmacovigilance study, thereby providing valuable insights for clinical practice.</p><p><strong>Design: </strong>Data on NSAID-associated small bowel bleeding were retrospectively extracted from two public adverse drug reaction databases-the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) and the Japan Pharmaceuticals and Medical Devices Agency's Adverse Drug Event Reporting (JADER)-from 2004 to 2023 for further analysis.</p><p><strong>Methods: </strong>The reporting odds ratio (ROR), a pharmacovigilance technique, was employed to identify signals of adverse reactions, and the Chi-square test was utilized to assess differences between groups.</p><p><strong>Results: </strong>Multiple NSAIDs associated with small bowel bleeding were identified in both databases. In the drug combination analysis, no significant differences in the risk of small bowel bleeding were found between NSAIDs combined with proton pump inhibitors (PPIs) and NSAIDs alone in FAERS (all <i>p</i> > 0.05). Decreasing risks were found when multiple NSAIDs were combined with rebamipide or probiotics compared to NSAIDs alone in JADER (<i>p</i> < 0.05 and ROR < 1). In subgroup analyses of age and sex, older adults and males who used aspirin showed higher risk signals in both databases (all <i>p</i> < 0.05 and ROR > 1).</p><p><strong>Conclusion: </strong>PPIs did not show a significant impact on NSAIDs-associated small bowel bleeding, while rebamipide and probiotics may exhibited a preventive effect against NSAIDs-associated small bowel bleeding. Older adults and males constituted risk factors for aspirin-associated small bowel bleeding.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251318848"},"PeriodicalIF":3.4000,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056324/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20420986251318848","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Currently, the factors influencing small bowel bleeding caused by nonsteroidal anti-inflammatory drugs (NSAIDs) remain unclear.
Objectives: This study aimed to assess NSAID-associated small bowel bleeding and evaluate the impact of other drugs on it through a pharmacovigilance study, thereby providing valuable insights for clinical practice.
Design: Data on NSAID-associated small bowel bleeding were retrospectively extracted from two public adverse drug reaction databases-the Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) and the Japan Pharmaceuticals and Medical Devices Agency's Adverse Drug Event Reporting (JADER)-from 2004 to 2023 for further analysis.
Methods: The reporting odds ratio (ROR), a pharmacovigilance technique, was employed to identify signals of adverse reactions, and the Chi-square test was utilized to assess differences between groups.
Results: Multiple NSAIDs associated with small bowel bleeding were identified in both databases. In the drug combination analysis, no significant differences in the risk of small bowel bleeding were found between NSAIDs combined with proton pump inhibitors (PPIs) and NSAIDs alone in FAERS (all p > 0.05). Decreasing risks were found when multiple NSAIDs were combined with rebamipide or probiotics compared to NSAIDs alone in JADER (p < 0.05 and ROR < 1). In subgroup analyses of age and sex, older adults and males who used aspirin showed higher risk signals in both databases (all p < 0.05 and ROR > 1).
Conclusion: PPIs did not show a significant impact on NSAIDs-associated small bowel bleeding, while rebamipide and probiotics may exhibited a preventive effect against NSAIDs-associated small bowel bleeding. Older adults and males constituted risk factors for aspirin-associated small bowel bleeding.
背景:目前,影响非甾体类抗炎药(NSAIDs)引起的小肠出血的因素尚不清楚。目的:本研究旨在通过药物警戒研究评估非甾体抗炎药相关小肠出血,并评估其他药物对其的影响,从而为临床实践提供有价值的见解。设计:回顾性地从2004年至2023年两个公共药物不良反应数据库——美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)和日本药品和医疗器械管理局的不良事件报告(JADER)中提取nsaid相关小肠出血的数据,以作进一步分析。方法:采用药物警戒技术报告优势比(ROR)识别不良反应信号,采用卡方检验评价组间差异。结果:在两个数据库中都发现了与小肠出血相关的多种非甾体抗炎药。在联合用药分析中,非甾体抗炎药联合质子泵抑制剂(PPIs)与单用非甾体抗炎药在FAERS中发生小肠出血的风险无显著差异(p < 0.05)。与单独使用非甾体抗炎药相比,在JADER中,多种非甾体抗炎药联合利巴米胺或益生菌可降低风险(p p 1)。结论:PPIs对非甾体抗炎药相关的小肠出血没有显著影响,而利巴米胺和益生菌可能对非甾体抗炎药相关的小肠出血有预防作用。老年人和男性是阿司匹林相关小肠出血的危险因素。
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.