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

Jung, Se Yong and Kim, Min Seo and Li, Han and Lee, Keum Hwa and Koyanagi, Ai and Solmi, Marco and Kronbichler, Andreas and Dragioti, Elena and Tizaoui, Kalthoum and Cargnin, Sarah and Terrazzino, Salvatore and Hong, Sung Hwi and Ghayda, Ramy A. and Kim, Nam Kyun and Chung, Seo Kyoung and Jacob, Louis and Salem, Joe‐Elie and Yon, Dong Keon and Lee, Seung Won and Kostev, Karel and Kim, Ah Young and Jung, Jo Won and Choi, Jae Young and Shin, Jin Soo and Park, Soon-Jung and Choi, Seong Woo and Ban, Kiwon and Moon, Sung-Hwan and Go, Yun Young and 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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Official URL: http://dx.doi.org/10.1111/cts.13168

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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