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 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.

HFrEF pharmacological treatment: digitalis glycosides

About 25 years ago, a series of trials suggested that withdrawal of digoxin from patients with heart failure who were stable, had mild symptoms, a reduced left ventricular ejection fraction, and in sinus rhythm could lead to worsening symptoms. Withdrawal of digoxin was also associated with a decline in renal function and weight gain, suggesting important renal effects, as well as a decline in left ventricular ejection fraction and exercise capacity. However, stopping a medication in a patient who has responded to it may carry bias; the effect of initiating digoxin in a digoxin-naïve patient is unknown. A large outcome study showed no effect on mortality. Since then, however, the evidence both for and against digoxin has been superseded by important innovations in therapy, such as beta blockers and mineralocorticoid antagonists. For patients in atrial fibrillation, evidence of a clinical benefit other than ventricular rate control, itself a controversial issue, is lacking. Current European Society of Cardiology Guidelines on heart failure suggest a limited role for digoxin for the management of symptoms of heart failure when other treatments have failed. New studies investigating the role of digitalis glycosides in patients with heart failure receiving contemporary background therapy are ongoing.