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Cardiac Adverse Events and Remdesivir in Hospitalized Patients With Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial

Data de publicação: Data Ahead of Print:

Autores da FMUP

  • José Artur Osório De Carvalho Paiva

    Autor

Participantes de fora da FMUP

  • Terzic, Vida
  • Basilua, Joe Miantezila
  • Billard, Nicolas
  • de Gastines, Lucie
  • Belhadi, Drifa
  • Fougerou-Leurent, Claire
  • Peiffer-Smadja, Nathan
  • Mercier, Noemie
  • Delmas, Christelle
  • Ferrane, Assia
  • Dechanet, Aline
  • Poissy, Julien
  • Esperou, Helene
  • Ader, Florence
  • Hites, Maya
  • Andrejak, Claire
  • Greil, Richard
  • Staub, Therese
  • Tacconelli, Evelina
  • Burdet, Charles
  • Costagliola, Dominique
  • Mentre, France
  • Yazdanpanah, Yazdan
  • Diallo, Alpha
  • DisCoVeRy Study Grp

Unidades de investigação

Abstract

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. NCT 04315948; EudraCT 2020-000936-23.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. NCT 04315948; EudraCT 2020-000936-23. The safety analysis from the randomized DisCoVeRy trial designed for hospitalized patients with moderate to severe coronavirus disease 2019 showed no significant association between remdesivir treatment compared with control in the occurrence of cardiac adverse events, including arrhythmias.

Dados da publicação

ISSN/ISSNe:
1537-6591, 1058-4838

Clinical Infectious Diseases  Oxford University Press

Tipo:
Article
Páginas:
382-391
Link para outro recurso:
www.scopus.com

Citações Recebidas na Web of Science: 1

Citações Recebidas na Scopus: 1

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Keywords

  • COVID-19; remdesivir; cardiac adverse events; randomized controlled trials; antiviral therapy

Campos de estudo

Proyectos asociados

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Investigador Principal: José Artur Osório de Carvalho Paiva

Estudo Clínico Académico (Antimicrobial consumpti) . 2021

Severe community-acquired pneumonia: from severity assessment to outcome.

Investigador Principal: José Artur Osório de Carvalho Paiva

Estudo Clínico Académico . 2022

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