基于FAERS 的老年2型糖尿病患者药物警戒信号挖掘分析

Mining and analysis of pharmacovigilance signals in elderly patients with type 2 diabetes mellitus based on FAERS

摘要:

目的 挖掘美国食品药品监督管理局不良事件报告系统（FAERS）老年2型糖尿病（T2DM）患者药物不良事件（ADE）并分析药物警戒（PV）信号，为老年T2DM患者PV提供参考。方法 挖掘FAERS中2012年第4季度至2022年第2季度老年T2DM患者的ADE报告，采用比例失衡分析法判定目标药物和事件，就药物-事件阳性PV信号与说明书对比和分析，并评估其在特定年龄段的老年T2DM患者中发生情况。结果 共检测出18个药物-事件阳性PV信号，有9个信号说明书未明确提及，其中4个未见有文献报道，分别是二甲双胍-急性肾损伤（AKI）、呋塞米-乳酸酸中毒（LA）、阿托伐他汀-LA和奥美拉唑-LA。在所有老年T2DM患者中，65~74岁患者出现的高风险药物-事件类型最多，罗格列酮引起充血性心力衰竭（CHF）风险最高。结论 本次数据挖掘在老年T2DM患者中发现9个说明书未明确提及的、潜在的药物-事件，可能与这类特定人群存在如高龄、肝肾功能不全、合并症或并发症以及多药联用等多种因素有关。提示不同年龄阶段的老年T2DM患者，在使用相关药物时需要重点关注的ADE情况。在所有老年T2DM患者中，罗格列酮引起CHF风险最高。

Abstract:

Objective To analyze the pharmacovigilance (PV) signals of elderly patients with type 2 diabetes mellitus (T2DM) from U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) by mining the adverse drug events (ADEs) and provide reference for PV in elderly patients with T2DM.Methods The ADE reports of elderly T2DM patients from Q4 2012 to Q2 2022 in FAERS were mined and disproportionality analysis method were used to determine the signal of target drugs and events. Drug-event positive PV signals with the instruction books to compared and analyzed, and their occurrence in elderly T2DM patients in a specific age group was evaluated.Results A total of 18 drug-event positive PV signals were detected, 9 of which were not explicitly mentioned in the instructions, 4 of which were not reported in the literature, including metformin-AKI, furosemide-LA, atorvastatin-LA, and omeprazole-LA. Among all elderly patients with T2DM, patients aged 65-74 years had the most high risk drug-event types. The risk of rosiglitazone congestive heart failure (CHF) signaling was highest.Conclusion In this data mining, 9 potential drug-events not explicitly mentioned in the instructions were found in elderly T2DM patients, which may be related to various factors such as advanced age, liver and kidney insufficiency, comorbidities or complications, and concomitant medication in this specific population.Remind elderly T2DM patients of different age groups to pay special attention to the ADE situation when using relevant drugs. Among all elderly T2DM patients, rosiglitazone has the highest risk of CHF.