Risk of Hospitalization Associated with Cardiovascular Medications in the Elderly Italian Population: A Nationwide Multicenter Study in Emergency Departments

Abstract

Background: 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.Methods: 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.Results: 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.Conclusion: 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.

Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

“…Main limitations and strengths of the MEREAFaPS Study have already been described [ 9 , 45 ]. For this specific post hoc analysis, limitations are mainly represented by the lack of information on drug use and regarding drug–drug combinations and interactions.…”

“…This is a post hoc analysis performed on pharmacovigilance reports of suspected AE collected between 1 January 2007 and 31 December 2018 in the EDs participating to the MEREAFaPS Study [ 9 , 45 , 46 , 47 ].…”

Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post-Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments

“…This is a post-hoc analysis performed on pharmacovigilance reports of suspected AE collected between January 1 st , 2007 and December 31 st , 2018 in the EDs participating to the MEREAFaPS Study [9,[45][46][47].…”

The Person’s Care Requires a Sex and Gender Approach

“…In particular, the majority of drugs excluded from the market for ADR occurred mainly in women ([ 6 ] and cited literature), more women than men are admitted to hospitals for ADR, and more female inpatients develop ADR [ 86 ]. An Italian study shows that ADR induced by cardiovascular drugs are more frequent in women than in men [ 87 ]. A narrative review concludes that to be of the female sex is a risk factor for cutaneous ADR, major bleeding, etc.…”

“…[ 88 ]. Conversely, some investigations show that fatal and more serious ADR occur more frequently in men than in women ([ 6 , 87 ] and cited literature). Interestingly, an analysis of the Swedish national pharmacovigilance database (2008–2011) shows that women and men have higher rates of nonserious and severe reactions, respectively [ 89 ].…”