Crescioli Giada, Bettiol Alessandra, Bonaiuti Roberto, Tuccori Marco, Rossi Marco, Capuano Annalisa, Pagani Silvia, Spada Giulia, Venegoni Mauro, Vighi Giuseppe Danilo, Mannaioni Guido, Vannacci Alfredo, Lombardi Niccolò
Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.
Tuscan Regional Center of Pharmacovigilance, Florence, Italy.
Front Pharmacol. 2021 Jan 29;11:611102. doi: 10.3389/fphar.2020.611102. eCollection 2020.
There is a significant gap in knowledge addressing cardiovascular (CV) medications safety in elderly. In this context, our purposes were to define clinical and pharmacological characteristics of outpatients' adverse drug events (ADEs) related to CV medications leading to emergency department (ED) visits in the elderly Italian patients according to different age groups, and to evaluate the risk of hospitalization associated to ADEs in this population. A multicentre, retrospective study was performed on reports of suspected ADEs collected between 2007-2018 in 94 EDs involved in the MEREAFaPS Study. Elderly patients who experienced one or more CV medications-related ADEs leading to ED visit were selected. Patients' characteristics, suspected (ATC classes B and C) and concomitant drugs, and ADE description were collected. Elderly patients were stratified into three age groups (65-74, 75-84, and ≥85 years) and compared to adults (18-64 years). Logistic regression analyses were used to estimate the reporting odds ratios (RORs) with 95% confidence intervals (CIs) of ADE-related hospitalization adjusting for sex, presence of two or more suspected drugs, concomitant drugs, and one or more comorbidities. Among elderly, 16,926 reports of suspected ADE related to CV medications were collected, and 6,694 (39.5%) resulted in hospitalization. Patients were mostly female, Caucasians, and middle-old (75-84). 78.9% of patients were treated with only one suspected drug, and 71.9% and 47.1% reported concomitant medications and comorbidities, respectively. Compared to adults, risk of hospitalization was significantly higher for middle-old and oldest-old patients exposed to vitamin K antagonists (1.29 [1.09-1.52] and 1.56 [1.30-187]), direct thrombin inhibitors (3.41 [1.44-8.08] and 4.12 [1.67-10.17]), antiplatelets (1.51 [1.26-1.81] and 2.09 [1.71-2.57]), and beta-blockers (1.89 [1.38-2.59 and 2.31 [1.60-3.35]). Overall, a higher risk of hospitalization was observed for renin-angiotensin system inhibitors (1.32 [1.04-1.68], 1.65 [1.32-2.06], and 2.20 [1.70-2.85]), presence of two or more concomitant drugs, and concomitant conditions. Our real-world findings underline relevant safety aspects of CV medications in the elderly Italian population. ED clinicians must always consider the higher risk of hospitalization related to the use of CV drugs in elderly, particularly in oldest-old ones, for antiarrhythmics, beta-blocking agents, renin-angiotensin system inhibitors, antiplatelets, and anticoagulants.
在解决老年人心血管（CV）药物安全性问题方面，知识存在重大差距。在此背景下，我们的目的是根据不同年龄组确定导致意大利老年患者前往急诊科（ED）就诊的与CV药物相关的门诊不良药物事件（ADEs）的临床和药理学特征，并评估该人群中与ADEs相关的住院风险。对参与MEREAFaPS研究的94个急诊科在2007年至2018年期间收集的疑似ADEs报告进行了一项多中心回顾性研究。选择经历过一次或多次导致ED就诊的与CV药物相关的ADEs的老年患者。收集患者特征、疑似（ATC分类B和C）及伴随药物，以及ADE描述。老年患者被分为三个年龄组（65 - 74岁、75 - 84岁和≥85岁），并与成年人（18 - 64岁）进行比较。使用逻辑回归分析来估计与ADE相关住院的报告比值比（RORs）及其95%置信区间（CIs），并对性别、两种或更多种疑似药物的存在、伴随药物以及一种或多种合并症进行校正。在老年人中，收集到16,926份与CV药物相关的疑似ADE报告，其中6,694份（39.5%）导致住院。患者大多为女性、白种人且为中老年（75 - 84岁）。78.9%的患者仅接受一种疑似药物治疗，分别有71.9%和47.1%的患者报告有伴随药物和合并症。与成年人相比，中老年和高龄患者使用维生素K拮抗剂（1.29 [1.09 - 1.52]和1.56 [1.30 - 1.87]）、直接凝血酶抑制剂（3.41 [1.44 - 8.08]和4.12 [1.67 - 10.17]）、抗血小板药物（1.51 [1.26 - 1.81]和2.09 [1.71 - 2.57]）以及β受体阻滞剂（1.89 [1.38 - 2.59]和2.31 [1.60 - 3.35]）时，住院风险显著更高。总体而言，肾素 - 血管紧张素系统抑制剂（1.32 [1.04 - 1.68]、1.65 [1.32 - 2.06]和2.20 [1.70 - 2.85]）、两种或更多种伴随药物的存在以及伴随疾病导致住院风险更高。我们的真实世界研究结果强调了意大利老年人群中CV药物的相关安全问题。急诊科临床医生必须始终考虑到老年人使用CV药物相关的更高住院风险，特别是在高龄患者中，对于抗心律失常药、β受体阻滞剂、肾素 - 血管紧张素系统抑制剂、抗血小板药物和抗凝剂而言。
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