Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

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

Version 1 : Received: 12 June 2021 / Approved: 15 June 2021 / Online: 15 June 2021 (11:51:17 CEST)

A peer-reviewed article of this Preprint also exists.

Crescioli, G.; Boscia, E.; Bettiol, A.; Pagani, S.; Spada, G.; Vighi, G.V.; Bonaiuti, R.; Venegoni, M.; Vighi, G.D.; Vannacci, A.; Lombardi, N.; on behalf of the MEREAFaPS Study Group. Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments. Pharmaceuticals 2021, 14, 678. Crescioli, G.; Boscia, E.; Bettiol, A.; Pagani, S.; Spada, G.; Vighi, G.V.; Bonaiuti, R.; Venegoni, M.; Vighi, G.D.; Vannacci, A.; Lombardi, N.; on behalf of the MEREAFaPS Study Group. Risk of Hospitalization for Adverse Drug Events in Women and Men: A Post Hoc Analysis of an Active Pharmacovigilance Study in Italian Emergency Departments. Pharmaceuticals 2021, 14, 678.

Journal reference: Pharmaceuticals 2021, 14, 678
DOI: 10.3390/ph14070678

Abstract

This post-hoc analysis of an Italian active pharmacovigilance study describes pharmacological differences of ADEs leading to emergency department (ED) visit and hospitalization in women and men. During the study period (January 2007 – December 2018), 61,855 reports of ADE leading to ED visit were collected. Overall, 30.6% of ADEs resulted in hospitalization (30% in women and 31% in men). Multivariate logistic regression showed that, among women, drug classes significantly associated with an increased risk of hospitalization were heparins (ROR 1.41, CI 1.13-176), antidepressants (ROR 1.12, CI 1.03-1.23) and antidiabetics (ROR 1.13, CI 1.02-1.24). Among men only vitamin K antagonists (ROR 1.28, CI 1.09-1.50), opioids (ROR 1.30, CI 1.06-1.60) and digitalis glycosides (ROR 1.32, CI 1.09-1.59) were associated with a higher risk of hospitalization. Overall, older age, multiple suspected drugs and the presence of comorbidi-ties were significantly associated with a higher risk of hospitalization. A significantly reduced risk of hospitalization was observed in both women and men experiencing and adverse event following immunization (ROR 0.36, CI 0.27-0.48 and 0.83, 0.42-0.74, respectively) compared to drugs. Results obtained from this real-world analysis highlight important aspects of drug safety between sexes.

Keywords

pharmacovigilance; clinical pharmacology; male; female; emergency department.

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