An observational, retrospective, comprehensive pharmacovigilance analysis of hydroxychloroquine-associated cardiovascular adverse events in patients with and without COVID-19 View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2022-07-20

AUTHORS

Min Luo, Bin Wu, Yuwen Li, Fengbo Wu

ABSTRACT

BackgroundCoronavirus disease 2019 (COVID-19) is a global pandemic. Hydroxychloroquine (HCQ)-associated cardiovascular adverse events (CVAEs) have been increasingly reported.AimThis study aimed to present an observational, retrospective, and comprehensive pharmacovigilance analysis of CVAE associated with HCQ in patients with and without COVID-19 using the US Food and Drug Administration Adverse Events Reporting System (FAERS) data from January 2020 to December 2020.MethodWe identified 3302 adverse event reports from the FAERS database in the year 2020 and divided them into COVID-19 and non-COVID-19 groups, respectively. Then we analyzed whether there were differences in CVAEs between the two groups.ResultsWe found that CVAE was higher in cases with COVID-19 compared to those without COVID-19, odds ratio (OR) of 1.26 and a 95% confidence interval (95% CI) of 1.02–1.54. Cases with COVID-19 treated with HCQ exhibited relatively higher proportions of torsade de points (TdP) and QT prolongation (OR 3.10, 95% CI 2.24–4.30), shock-associated TdP (OR 2.93, 95% CI 2.13–4.04), cardiac arrhythmias (OR 2.07, 95% CI 1.60–2.69), cardiac arrhythmia terms (including bradyarrhythmias and tachyarrhythmias) (OR 2.15, 95% CI 1.65–2.80), bradyarrhythmias (including conduction defects and disorders of sinus node function) (OR 2.56, 95% CI 1.86–3.54), and conduction defects (OR 2.56, 95% CI 1.86–3.54).ConclusionOur retrospective observational analysis suggested that the proportion of CVAE associated with HCQ, especially TdP and QT prolongation, was higher in patients with COVID-19. Understanding the effects of COVID-19 on the cardiovascular system is essential to providing comprehensive medical care to patients receiving HCQ treatment. More... »

PAGES

1179-1187

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s11096-022-01457-w

DOI

http://dx.doi.org/10.1007/s11096-022-01457-w

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1149602632

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/35857159


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