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

Jung, Se Yong, Kim, Min Seo, Li, Han, Lee, Keum Hwa, Koyanagi, Ai, Solmi, Marco, Kronbichler, Andreas, Dragioti, Elena, Tizaoui, Kalthoum, Cargnin, Sarah, Terrazzino, Salvatore, Hong, Sung Hwi, Ghayda, Ramy A., Kim, Nam Kyun, Chung, Seo Kyoung, Jacob, Louis, Salem, Joe‐Elie, Yon, Dong Keon, Lee, Seung Won, Kostev, Karel, Kim, Ah Young, Jung, Jo Won, Choi, Jae Young, Shin, Jin Soo, Park, Soon-Jung, Choi, Seong Woo, Ban, Kiwon, Moon, Sung-Hwan, Go, Yun Young, Shin, Jae Il and Smith, Lee (2022) Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database. Clinical and Translational Science, 15 (2). pp. 501-513. ISSN 1752-8062

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Abstract

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.

Item Type:	Journal Article
Faculty:	Faculty of Science & Engineering
SWORD Depositor:	Symplectic User
Depositing User:	Symplectic User
Date Deposited:	03 Nov 2021 10:33
Last Modified:	13 Jun 2022 13:28
URI:	https://arro.anglia.ac.uk/id/eprint/707069

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