Lovekirat Dhaliwal, MD
Resident
Louisiana State University Health Sciences Center, Louisiana, United States
Disclosure information not submitted.
Sukhmani Boparai, MD
Resident Physician
LSU Health Shreveport
Shreveport
Disclosure information not submitted.
Cesar Davila-Chapa, MD
Resident Physician
LSU Health Shreveport
Shreveport, Louisiana
Disclosure information not submitted.
Prathik Krishnan, MD
Assistant Professor of Clinical Medicine
Louisiana State University Health Sciences, United States
Disclosure information not submitted.
Paari Dominic, MD
Associate Professor of Cardiology
Ochsner LSU Health Shreveport, United States
Disclosure information not submitted.
Title: Remdesivir and Cardiac Arrhythmia in COVID-19
Introduction: Remdesivir is an antiviral therapy that has shown significant benefit in hypoxic patients admitted to the hospital for COVID-19 pneumonia. However, cardiac arrhythmias, including atrial fibrillation, supraventricular arrhythmias, and other nonspecific arrhythmias, have been reported as an adverse event (AE) in 2.6% of the patients in a randomized control trial. Multiple case reports have also highlighted the occurrence of marked sinus bradycardia. This study aims to investigate further the association of remdesivir with cardiac arrhythmias using the FDA adverse Event Reporting System (FAERS) database.
Methods: We used the FAERS to analyze all reports of cardiac arrhythmia listed as an adverse event with remdesivir use from January 2020 till July 2021. We created the dataset of most commonly reported arrhythmia by searching FAERS for the terms “bradycardia", “sinus bradycardia” and “bradyarrhythmia”. Duplicates were removed using case ID. We calculated the reporting odds ratio (ROR) to assess the potential of bradycardia as AE for remdesivir. ROR was calculated by comparing the odds of bradycardia with remdesivir use and all other products in the database.
Results: FAERS database has 2,810,018 total AE reported from January 2020 till July 2021. Remdesivir has a total of 5,436 AE reported, among which 761 were cardiac-related AE. Arrhythmia was reported in 516 cases, of which bradycardia was the most commonly seen in 351 cases, followed by atrial fibrillation in 74 cases. Most cases of bradycardia were reported in adults age 18-85 years, out of which 61.8% (217) were male. The ROR suggests that remdesivir use is significantly associated with bradycardia (ROR 30.28, 95% CI 27.10-33.84, p< .0001).
Conclusions: We conclude that remdesivir use is associated with increased risk of bradycardia. However, potential confounding factors (such as baseline comorbidities, other medications, sedation) could have influenced the results. Larger retrospective or prospective studies are needed to assess the clinical significance of this association and risk factors for occurrence.