Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial.
COVID-19
antiviral therapy
cardiac adverse events
randomized controlled trials
remdesivir
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
29 Mar 2024
29 Mar 2024
Historique:
received:
28
09
2023
revised:
07
12
2023
accepted:
13
12
2023
medline:
29
3
2024
pubmed:
29
3
2024
entrez:
29
3
2024
Statut:
aheadofprint
Résumé
We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with Coronavirus Disease 2019 (COVID-19) receiving remdesivir plus standard of care (SoC) compared to SoC alone (control), as an association was noted in some cohort studies and disproportionality analyses of safety databases. This post-hoc safety analysis is based on data from the multicenter, randomized, open-label, controlled DisCoVeRy trial in hospitalized patients with COVID-19 (NCT04315948). Any first AE occurring 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. 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 (HR 1.0, 95% CI 0.7-1.5, p = 0.98), even when evaluating serious and non-serious cardiac AEs 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 remdesivir and control groups in the occurrence of different cardiac AE subclasses, including arrhythmic events (HR 1.1, 95% CI: 0.7-1.7, p = 0.68). Remdesivir treatment was not associated with an increased risk of cardiac AEs, whether serious or not, and regardless of AE severity, compared to control, in patients hospitalized with moderate or severe COVID-19. This is consistent with the results of other randomized controlled trials and meta-analyses.
Sections du résumé
BACKGROUND
BACKGROUND
We aimed to evaluate the cardiac adverse events (AEs) in hospitalized patients with Coronavirus Disease 2019 (COVID-19) receiving remdesivir plus standard of care (SoC) compared to SoC alone (control), as an association was noted in some cohort studies and disproportionality analyses of safety databases.
METHODS
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 (NCT04315948). Any first AE occurring 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
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 (HR 1.0, 95% CI 0.7-1.5, p = 0.98), even when evaluating serious and non-serious cardiac AEs 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 remdesivir and control groups in the occurrence of different cardiac AE subclasses, including arrhythmic events (HR 1.1, 95% CI: 0.7-1.7, p = 0.68).
CONCLUSIONS
CONCLUSIONS
Remdesivir treatment was not associated with an increased risk of cardiac AEs, whether serious or not, and regardless of AE severity, compared to control, in patients hospitalized with moderate or severe COVID-19. This is consistent with the results of other randomized controlled trials and meta-analyses.
Identifiants
pubmed: 38552208
pii: 7637630
doi: 10.1093/cid/ciae170
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Investigateurs
Sandrine Couffin-Cadièrgues
(S)
Hélène Esperou
(H)
Bernd Lamprecht
(B)
Michael Joannidis
(M)
Alexander Egle
(A)
Richard Greil
(R)
Antoine Altdorfer
(A)
Vincent Fraipont
(V)
Leila Belkhir
(L)
Maya Hites
(M)
Gil Verschelden
(G)
Violaine Tolsma
(V)
David Bougon
(D)
Agathe Delbove
(A)
Marie Gousseff
(M)
Nadia Saidani
(N)
Guilhem Wattecamps
(G)
Félix Djossou
(F)
Loïc Epelboin
(L)
Jean-Philippe Lanoix
(JP)
Pierre-Alexandre Roger
(PA)
Claire Andrejak
(C)
Yoann Zerbib
(Y)
Kevin Bouiller
(K)
Catherine Chirouze
(C)
Jean-Christophe Navellou
(JC)
Alexandre Boyer
(A)
Charles Cazanave
(C)
Alexandre Duvignaud
(A)
Didier Gruson
(D)
Denis Malvy
(D)
Henry Lessire
(H)
Martin Martinot
(M)
Pascal Andreu
(P)
Mathieu Blot
(M)
Lionel Piroth
(L)
Jean Pierre Quenot
(JP)
Olivier Epaulard
(O)
Nicolas Terzi
(N)
Karine Faure
(K)
Emmanuel Faure
(E)
Julien Poissy
(J)
Saad Nseir
(S)
Florence Ader
(F)
Laurent Argaud
(L)
Tristan Ferry
(T)
Thomas Perpoint
(T)
Vincent Piriou
(V)
Jean-Christophe Richard
(JC)
Julien Textoris
(J)
Florent Valour
(F)
Florent Wallet
(F)
André Cabié
(A)
Jean-Marie Turmel
(JM)
Cyrille Chabartier
(C)
Rostane Gaci
(R)
Céline Robert
(C)
Alain Makinson
(A)
Vincent Le Moing
(V)
Kada Klouche
(K)
Olivier Hinschberger
(O)
Joy Mootien
(J)
Sébastien Gibot
(S)
François Goehringer
(F)
Antoine Kimmoun
(A)
Benjamin Lefevre
(B)
David Boutoille
(D)
Emmanuel Canet
(E)
Benjamin Gaborit
(B)
Paul Le Turnier
(P)
François Raffi
(F)
Jean Reignier
(J)
Johan Courjon
(J)
Jean Dellamonica
(J)
Sylvie Leroy
(S)
Charles-Hugo Marquette
(CH)
Paul Loubet
(P)
Claire Roger
(C)
Albert Sotto
(A)
Cédric Bruel
(C)
Benoît Pilmis
(B)
Guillaume Geri
(G)
Elisabeth Rouveix-Nordon
(E)
Olivier Bouchaud
(O)
Samy Figueiredo
(S)
Stéphane Jaureguiberry
(S)
Xavier Monnet
(X)
Lila Bouadma
(L)
François-Xavier Lescure
(FX)
Nathan Peiffer-Smadja
(N)
Jean-François Timsit
(JF)
Yazdan Yazdanpanah
(Y)
Solen Kerneis
(S)
Marie Lachâtre
(M)
Odile Launay
(O)
Jean-Paul Mira
(JP)
Julien Mayaux
(J)
Valérie Pourcher
(V)
Jérôme Aboab
(J)
Flora Crockett
(F)
Naomi Sayre
(N)
Clément Dubost
(C)
Cécile Ficko
(C)
David Lebeaux
(D)
Sébastien Gallien
(S)
Armand Mekontso-Dessap
(A)
Jérôme Le Pavec
(J)
Francois Stefan
(F)
Hafid Ait-Oufella
(H)
Karine Lacombe
(K)
Jean-Michel Molina
(JM)
Murielle Fartoukh
(M)
Gilles Pialoux
(G)
Firouzé Bani-Sadr
(F)
Bruno Mourvillier
(B)
François Benezit
(F)
Fabrice Laine
(F)
Bruno Laviolle
(B)
Yves Le Tulzo
(Y)
Matthieu Revest
(M)
Elisabeth Botelho-Nevers
(E)
Amandine Gagneux-Brunon
(A)
Guillaume Thiery
(G)
François Danion
(F)
Yves Hansmann
(Y)
Ferhat Meziani
(F)
Walid Oulehri
(W)
Charles Tacquard
(C)
Fanny Bounes-Vardon
(F)
Guillaume Martin-Blondel
(G)
Marlène Murris-Espin
(M)
Béatrice Riu-Poulenc
(B)
Vanessa Jeanmichel
(V)
Eric Senneville
(E)
Louis Bernard
(L)
Denis Garot
(D)
Jean Reuter
(J)
Thérèse Staub
(T)
Marc Berna
(M)
Sandra Braz
(S)
Joao Miguel Ferreira Ribeiro
(JMF)
José-Artur Paiva
(JA)
Roberto Roncon-Albuquerque
(R)
Benjamin Leveau
(B)
Informations de copyright
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.