Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database.
Journal: Clinical and translational science
Volume: 15
Issue: 2
Year of Publication: 2022
Affiliated Institutions:
Division of Pediatric Cardiology, Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
College of Medicine, Korea University, Seoul, Korea.
University of Florida College of Medicine, Gainesville, Florida, USA.
Department of Pediatrics, Yonsei University College of Medicine, Seoul, Korea.
Research and Development Unit, Parc Sanitari Sant Joan de Déu, Universitat de Barcelona, Fundació Sant Joan de Déu, CIBERSAM, Barcelona, Spain.
Department of Psychiatry, University of Ottawa, Ottawa, Ontario, Canada.
Department of Internal Medicine IV, Medical University Innsbruck, Innsbruck, Austria.
Department of Health, Medicine and Caring Sciences, Pain and Rehabilitation Centre, Linköping University, Linköping, Sweden.
Laboratory Microorganismes and Active Biomolecules, Sciences Faculty of Tunis, Tunis El Manar University, Tunis, Tunisia.
Department of Pharmaceutical Sciences, Interdepartmental Research Center of Pharmacogenetics and Pharmacogenomics (CRIFF), University of Piemonte Orientale, Novara, Italy.
Yonsei University College of Medicine, Seoul, Korea.
Urology Institute, University Hospitals and Case Western Reserve University, Cleveland, Ohio, USA.
Department of Pediatrics, Emory University, Atlanta, Georgia, USA.
College of Medicine, Ewha Womans University, Seoul, Korea.
Department of Pharmacology, INSERM, CIC- Paris-Est, CLIP Galilée, UNICO-GRECO Cardio-oncology Program, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, Sorbonne Université, Paris, France.
Department of Pediatrics, Seoul National University Children's Hospital, Seoul National University College of Medicine, Seoul, Korea.
Department of Data Science, Sejong University College of Software Convergence, Seoul, Korea.
University Clinic of Marburg, Marburg, Germany.
Infectious Disease Research Center, Korea Research Institute of Chemical Technology, Daejeon, Korea.
Stem Cell Research Institute, T&R Biofab Co. Ltd, Siheung, Korea.
Department of Physiology, Ischemic/Hypoxic Disease Institute, Seoul National University College of Medicine, Seoul, Korea.
Department of Biomedical Sciences, City University of Hong Kong, Hong Kong SAR, China.
Department of Infectious Diseases and Public Health, City University of Hong Kong, Hong Kong SAR, China.
The Cambridge Centre for Sport and Exercise Sciences, Anglia Ruskin University, Cambridge, UK.
Abstract summary
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.
Authors & Co-authors:
Jung Se Yong SY
Kim Min Seo MS
Li Han H
Lee Keum Hwa KH
Koyanagi Ai A
Solmi Marco M
Kronbichler Andreas A
Dragioti Elena E
Tizaoui Kalthoum K
Cargnin Sarah S
Terrazzino Salvatore S
Hong Sung Hwi SH
Abou Ghayda Ramy R
Kim Nam Kyun NK
Chung Seo Kyoung SK
Jacob Louis L
Salem Joe-Elie JE
Yon Dong Keon DK
Lee Seung Won SW
Kostev Karel K
Kim Ah Young AY
Jung Jo Won JW
Choi Jae Young JY
Shin Jin Soo JS
Park Soon-Jung SJ
Choi Seong Woo SW
Ban Kiwon K
Moon Sung-Hwan SH
Go Yun Young YY
Shin Jae Il JI
Smith Lee L
Study Outcome
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