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Cardiac Adverse Events and Remdesivir in Hospitalized Patients With COVID-19: A Post Hoc Safety Analysis of the
Vida Terzić1,2, Joe Miantezila Basilua1,2, Nicolas Billard3
1Clinical Trial Safety and Public Health, ANRS|Emerging Infectious Diseases, Paris, France.
Insights
Remdesivir treatment did not increase cardiac adverse events (AEs) in hospitalized COVID-19 patients. This study found no significant difference in cardiac AEs between remdesivir plus standard of care and standard of care alone.
Area of Science:
- Cardiology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Previous studies suggested a potential link between remdesivir and cardiac adverse events (AEs) in COVID-19 patients.
- Concerns arose from cohort studies and safety database analyses regarding cardiac safety of remdesivir.
Purpose of the Study:
- To evaluate the incidence of cardiac AEs in hospitalized COVID-19 patients treated with remdesivir plus standard of care (SoC) versus SoC alone.
- To determine if remdesivir is associated with an increased risk of cardiac complications in COVID-19 patients.
Main Methods:
- A post hoc safety analysis from the multicenter, randomized, open-label DisCoVeRy trial.
- Kaplan-Meier survival curves were used to analyze the first cardiac AE occurring between randomization and day 29 in the modified intention-to-treat (mITT) population.
- Event rates were calculated using Kaplan-Meier estimates.
Main Results:
- Cardiac AEs occurred in 11.2% of patients receiving remdesivir and 11.3% receiving SoC alone (HR, 1.0; 95% CI, .7-1.5; P = .98).
- No significant difference in cardiac AE risk was observed between the groups, including serious and nonserious events.
- The majority of cardiac AEs were arrhythmias with favorable outcomes in both groups.
Conclusions:
- Remdesivir treatment is not associated with an increased risk of cardiac AEs in hospitalized patients with moderate to severe COVID-19.
- Findings align with existing data from randomized controlled trials and meta-analyses on remdesivir's cardiac safety.
- Clinical trial registration numbers: NCT04315948; EudraCT 2020-000936-23.
Background:
We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with coronavirus disease 2019 (COVID-19) who received remdesivir plus standard of care (SoC) compared with SoC alone (control), as an association was noted in some cohort studies and disproportionality analyses of safety databases.
Methods:
This post hoc safety analysis is based on data from the multicenter, randomized, open-label, controlled DisCoVeRy trial in hospitalized patients with COVID-19. Any first AE that occurred between randomization and day 29 in the modified intention-to-treat (mITT) population randomized to either remdesivir or control group was considered. Analysis was performed using Kaplan-Meier survival curves, and Kaplan-Meier estimates were calculated for event rates.
Results:
Cardiac AEs were reported in 46 (11.2%) of 410 and 48 (11.3%) of 423 patients in the mITT population (n = 833) enrolled in the remdesivir and control groups, respectively. The difference between both groups was not significant (hazard ratio [HR], 1.0; 95% confidence interval [CI], .7-1.5; P = .98), even when serious and nonserious cardiac AEs were evaluated separately. The majority of reports in both groups were of arrhythmic nature (remdesivir, 84.8%; control, 83.3%) and were associated with a favorable outcome. There was no significant difference between the two groups in the occurrence of cardiac AE subclasses, including arrhythmic events (HR, 1.1; 95% CI, .7-1.7; P = .68).
Conclusions:
Remdesivir treatment was not associated with an increased risk of cardiac AEs compared with control in patients hospitalized with moderate or severe COVID-19. These results are consistent with other randomized, controlled trials and meta-analyses. Clinical Trials Registration. NCT04315948; EudraCT 2020-000936-23.
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