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

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 ai...

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Detalles Bibliográficos
Autores principales: 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, Abou Ghayda, Ramy, 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, Smith, Lee
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8841455/
https://www.ncbi.nlm.nih.gov/pubmed/34719115
http://dx.doi.org/10.1111/cts.13168
Descripción
Sumario: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.