Potential remdesivir‐related transient bradycardia in patients with coronavirus disease 2019 (COVID‐19)

Pallotto, Carlo; Suardi, L; Gabbuti, Andrea; Esperti, Sara; Mecocci, Lorenzo; Blanc, Pierluigi

doi:10.1002/jmv.26898

Cited by 21 publications

(39 citation statements)

References 7 publications

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“…Apart from these investigational therapies, other factors, ranging from channelopathies to medication compliance, may also contribute to cardiovascular complications. As for the approved anti-viral agent, remdesivir, there has been reported episodes of bradycardia related to its use [ 66 ].…”

Section: Pathophysiology Of Covid-19-associated Cardiovascular Complicationsmentioning

confidence: 99%

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COVID-19-Associated Cardiovascular Complications

et al. 2021

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Coronavirus disease 2019 (COVID-19) has been reported to cause cardiovascular complications such as myocardial injury, thromboembolic events, arrhythmia, and heart failure. Multiple mechanisms—some overlapping, notably the role of inflammation and IL-6—potentially underlie these complications. The reported cardiac injury may be a result of direct viral invasion of cardiomyocytes with consequent unopposed effects of angiotensin II, increased metabolic demand, immune activation, or microvascular dysfunction. Thromboembolic events have been widely reported in both the venous and arterial systems that have attracted intense interest in the underlying mechanisms. These could potentially be due to endothelial dysfunction secondary to direct viral invasion or inflammation. Additionally, thromboembolic events may also be a consequence of an attempt by the immune system to contain the infection through immunothrombosis and neutrophil extracellular traps. Cardiac arrhythmias have also been reported with a wide range of implicated contributory factors, ranging from direct viral myocardial injury, as well as other factors, including at-risk individuals with underlying inherited arrhythmia syndromes. Heart failure may also occur as a progression from cardiac injury, precipitation secondary to the initiation or withdrawal of certain drugs, or the accumulation of des-Arg9-bradykinin (DABK) with excessive induction of pro-inflammatory G protein coupled receptor B1 (BK1). The presenting cardiovascular symptoms include chest pain, dyspnoea, and palpitations. There is currently intense interest in vaccine-induced thrombosis and in the treatment of Long COVID since many patients who have survived COVID-19 describe persisting health problems. This review will summarise the proposed physiological mechanisms of COVID-19-associated cardiovascular complications.

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Section: Pathophysiology Of Covid-19-associated Cardiovascular Complicationsmentioning

confidence: 99%

“…Summary of proposed COVID-19 therapies and their potential cardiovascular complications[8,57,[60][61][62][63][64][65][66].…”

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COVID-19-Associated Cardiovascular Complications

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“…We have read the paper by Pallotto et al 1 reporting transient bradycardia in coronavirus‐19 disease (COVID‐19) patients receiving remdesivir with great interest. At the moment, remdesivir is the only specific antiviral agent approved for the treatment of severe COVID‐19.…”

Section: Tablementioning

confidence: 99%

“…Prompted by the study by Palloto et al 1 and reports on potential cardiovascular side‐effects of the drug, we prospectively performed the cross‐sectional electrocardiographic (ECG) pilot study in 14 consecutive patients with severe COVID‐19 treated with remdesivir and dexamethasone in our institution in April 2021. An ECG tracing was recorded before and 2 h after the remdesivir infusion.…”

Section: Tablementioning

confidence: 99%

“…4,5 Several small postmarketing studies and case reports reported cardiovascular sideeffects of remdesivir including bradycardia, hypotension, QTc interval prolongation, nonspecific T-wave changes, and cardiac arrest. [6][7][8][9] Prompted by the study by Palloto et al 1 and reports on potential cardiovascular side-effects of the drug, we prospectively performed the cross-sectional electrocardiographic (ECG) pilot study in 14 consecutive patients with severe COVID-19 treated with remdesivir and dexamethasone in our institution in April 2021. An ECG tracing was recorded before and 2 h after the remdesivir infusion.…”

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Remdesivir might induce changes in electrocardiogram beyond bradycardia in patients with coronavirus disease 2019—The pilot study

Bistrović

Lucijanić

2021

Journal of Medical Virology

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Identification of Bradycardia Following Remdesivir Administration Through the US Food and Drug Administration American College of Medical Toxicology COVID-19 Toxic Pharmacovigilance Project

et al. 2023

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ImportanceThe rapid spread and mortality associated with COVID-19 emphasized a need for surveillance system development to identify adverse events (AEs) to emerging therapeutics. Bradycardia is a remdesivir infusion–associated AE listed in the US Food and Drug Administration–approved prescribing information.ObjectiveTo evaluate the magnitude and duration of bradycardic events following remdesivir administration.Design, Setting, and ParticipantsA multicenter cohort study of patients with recorded heart rate less than 60 beats per minute within 24 hours after administration of a remdesivir dose was conducted between November 23, 2020, and October 31, 2021. Participants included patients hospitalized with COVID-19 at 15 medical centers across the US. Patients excluded had AEs unrelated to bradycardia, AEs in addition to bradycardia, or first onset of bradycardia after 5 remdesivir doses.ExposuresRemdesivir administration.Main Outcomes and MeasuresLinear mixed-effect models for the minimum HR before starting remdesivir and within 24 hours of each dose included doses as fixed effects. Baseline covariates were age (≥65 years vs &lt;65 years), sex (male vs female), cardiovascular disease history (yes vs no), and concomitant use of bradycardia-associated medications. The interactions between variables and doses were considered fixed-effects covariates to adjust models.ResultsA total of 188 patients were included in the primary analysis and 181 in the secondary analysis. The cohort included 108 men (57.4%); 75 individuals (39.9%) were non-Hispanic White and mean (SD) age was 61.3 (15.4) years. Minimum HR after doses 1 to 5 was lower than before remdesivir. Mean minimum HR was lowest after dose 4, decreasing by −15.2 beats per minute (95% CI, −17.4 to −13.1; P &lt; .001) compared with before remdesivir administration. Mean (SD) minimum HR was 55.6 (10.2) beats per minute across all 5 doses. Of 181 patients included in time-to-event analysis, 91 had their first episode of bradycardia within 23.4 hours (95% CI, 20.1-31.5 hours) and 91 had their lowest HR within 60.7 hours (95% CI, 54.0-68.3 hours). Median time to first bradycardia after starting remdesivir was shorter for patients aged 65 years or older vs those younger than 65 years (18.7 hours; 95% CI, 16.8-23.7 hours vs 31.5 hours; 95% CI, 22.7-39.3 hours; P = .04). Median time to lowest HR was shorter for men vs women (54.2 hours; 95% CI, 47.3-62.0 hours vs 71.0 hours; 95% CI, 59.5-79.6 hours; P = .02).Conclusions and RelevanceIn this cohort study, bradycardia occurred during remdesivir infusion and persisted. Given the widespread use of remdesivir, practitioners should be aware of this safety signal.

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Potential remdesivir‐related transient bradycardia in patients with coronavirus disease 2019 (COVID‐19)

Abstract: To the Editor, Coronavirus disease 2019 (COVID-19) is still a global concern with elevated morbidity and mortality. 1-3 Several drugs were evaluated, but, until now, only remdesivir (RDV), an inhibitor of the viral RNA-PEER REVIEW

Cited by 21 publications

References 7 publications

COVID-19-Associated Cardiovascular Complications

COVID-19-Associated Cardiovascular Complications

Remdesivir might induce changes in electrocardiogram beyond bradycardia in patients with coronavirus disease 2019—The pilot study

Identification of Bradycardia Following Remdesivir Administration Through the US Food and Drug Administration American College of Medical Toxicology COVID-19 Toxic Pharmacovigilance Project

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