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Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database

 Se Yong Jung  ;  Min Seo Kim  ;  Han Li  ;  Keum Hwa Lee  ;  Ai Koyanagi  ;  Marco Solmi  ;  Andreas Kronbichler  ;  Elena Dragioti  ;  Kalthoum Tizaoui  ;  Sarah Cargnin  ;  Salvatore Terrazzino  ;  Sung Hwi Hong  ;  Ramy Abou Ghayda  ;  Nam Kyun Kim  ;  Seo Kyoung Chung  ;  Louis Jacob  ;  Joe-Elie Salem  ;  Dong Keon Yon  ;  Seung Won Lee  ;  Karel Kostev  ;  Ah Young Kim  ;  Jo Won Jung  ;  Jae Young Choi  ;  Jin Soo Shin  ;  Soon-Jung Park  ;  Seong Woo Choi  ;  Kiwon Ban  ;  Sung-Hwan Moon  ;  Yun Young Go  ;  Jae Il Shin  ;  Lee Smith 
 Clinical and Translational Science, Vol.15(2) : 501-513, 2022-02 
Journal Title
Clinical and Translational Science
Issue Date
Adenosine Monophosphate / adverse effects ; Adenosine Monophosphate / analogs & derivatives* ; Alanine / adverse effects ; Alanine / analogs & derivatives* ; Antiviral Agents / adverse effects* ; COVID-19 / drug therapy* ; Cardiovascular Diseases / chemically induced* ; Databases, Factual ; Humans ; Myocytes, Cardiac / drug effects ; Pharmacovigilance* ; Retrospective Studies ; SARS-CoV-2* ; World Health Organization
On October 2020, the US Food and Drug Administration (FDA) approved remdesivir as the first drug for the treatment of coronavirus disease 2019 (COVID-19), increasing remdesivir prescriptions worldwide. However, potential cardiovascular (CV) toxicities associated with remdesivir remain unknown. We aimed to characterize the CV adverse drug reactions (ADRs) associated with remdesivir using VigiBase, an individual case safety report database of the World Health Organization (WHO). Disproportionality analyses of CV-ADRs associated with remdesivir were performed using reported odds ratios and information components. We conducted in vitro experiments using cardiomyocytes derived from human pluripotent stem cell cardiomyocytes (hPSC-CMs) to confirm cardiotoxicity of remdesivir. To distinguish drug-induced CV-ADRs from COVID-19 effects, we restricted analyses to patients with COVID-19 and found that, after adjusting for multiple confounders, cardiac arrest (adjusted odds ratio [aOR]: 1.88, 95% confidence interval [CI]: 1.08-3.29), bradycardia (aOR: 2.09, 95% CI: 1.24-3.53), and hypotension (aOR: 1.67, 95% CI: 1.03-2.73) were associated with remdesivir. In vitro data demonstrated that remdesivir reduced the cell viability of hPSC-CMs in time- and dose-dependent manners. Physicians should be aware of potential CV consequences following remdesivir use and implement adequate CV monitoring to maintain a tolerable safety margin.
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1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Thoracic and Cardiovascular Surgery (흉부외과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Nam Kyun(김남균) ORCID logo https://orcid.org/0000-0001-6923-230X
Kim, Ah Young(김아영) ORCID logo https://orcid.org/0000-0002-0713-4461
Shin, Jae Il(신재일) ORCID logo https://orcid.org/0000-0003-2326-1820
Lee, Keum Hwa(이금화) ORCID logo https://orcid.org/0000-0002-1511-9587
Jung, Se Yong(정세용) ORCID logo https://orcid.org/0000-0003-1337-563X
Jung, Jo Won(정조원)
Choi, Jae Young(최재영) ORCID logo https://orcid.org/0000-0002-1247-6669
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