Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19) : A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America..
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: 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: 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: 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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
|---|---|
| Enthalten in: |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - (2024) vom: 29. März |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Terzić, Vida [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Antiviral therapy |
|---|
| Anmerkungen: |
Date Revised 29.03.2024 published: Print-Electronic Citation Status Publisher |
|---|
| doi: |
10.1093/cid/ciae170 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM370417399 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM370417399 | ||
| 003 | DE-627 | ||
| 005 | 20240331002420.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240331s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/cid/ciae170 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1357.xml |
| 035 | |a (DE-627)NLM370417399 | ||
| 035 | |a (NLM)38552208 | ||
| 035 | |a (PII)ciae170 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Terzić, Vida |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19) |b A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 29.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a antiviral therapy | |
| 650 | 4 | |a cardiac adverse events | |
| 650 | 4 | |a randomized controlled trials | |
| 650 | 4 | |a remdesivir | |
| 700 | 1 | |a Miantezila Basilua, Joe |e verfasserin |4 aut | |
| 700 | 1 | |a Billard, Nicolas |e verfasserin |4 aut | |
| 700 | 1 | |a de Gastines, Lucie |e verfasserin |4 aut | |
| 700 | 1 | |a Belhadi, Drifa |e verfasserin |4 aut | |
| 700 | 1 | |a Fougerou-Leurent, Claire |e verfasserin |4 aut | |
| 700 | 1 | |a Peiffer-Smadja, Nathan |e verfasserin |4 aut | |
| 700 | 1 | |a Mercier, Noémie |e verfasserin |4 aut | |
| 700 | 1 | |a Delmas, Christelle |e verfasserin |4 aut | |
| 700 | 1 | |a Ferrane, Assia |e verfasserin |4 aut | |
| 700 | 1 | |a Dechanet, Aline |e verfasserin |4 aut | |
| 700 | 1 | |a Poissy, Julien |e verfasserin |4 aut | |
| 700 | 1 | |a Espérou, Hélène |e verfasserin |4 aut | |
| 700 | 1 | |a Ader, Florence |e verfasserin |4 aut | |
| 700 | 1 | |a Hites, Maya |e verfasserin |4 aut | |
| 700 | 1 | |a Andrejak, Claire |e verfasserin |4 aut | |
| 700 | 1 | |a Greil, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Paiva, José-Artur |e verfasserin |4 aut | |
| 700 | 1 | |a Staub, Thérèse |e verfasserin |4 aut | |
| 700 | 1 | |a Tacconelli, Evelina |e verfasserin |4 aut | |
| 700 | 1 | |a Burdet, Charles |e verfasserin |4 aut | |
| 700 | 1 | |a Costagliola, Dominique |e verfasserin |4 aut | |
| 700 | 1 | |a Mentré, France |e verfasserin |4 aut | |
| 700 | 1 | |a Yazdanpanah, Yazdan |e verfasserin |4 aut | |
| 700 | 1 | |a Diallo, Alpha |e verfasserin |4 aut | |
| 700 | 0 | |a DisCoVeRy study group |e verfasserin |4 aut | |
| 700 | 1 | |a Couffin-Cadièrgues, Sandrine |e investigator |4 oth | |
| 700 | 1 | |a Esperou, Hélène |e investigator |4 oth | |
| 700 | 1 | |a Lamprecht, Bernd |e investigator |4 oth | |
| 700 | 1 | |a Joannidis, Michael |e investigator |4 oth | |
| 700 | 1 | |a Egle, Alexander |e investigator |4 oth | |
| 700 | 1 | |a Greil, Richard |e investigator |4 oth | |
| 700 | 1 | |a Altdorfer, Antoine |e investigator |4 oth | |
| 700 | 1 | |a Fraipont, Vincent |e investigator |4 oth | |
| 700 | 1 | |a Belkhir, Leila |e investigator |4 oth | |
| 700 | 1 | |a Hites, Maya |e investigator |4 oth | |
| 700 | 1 | |a Verschelden, Gil |e investigator |4 oth | |
| 700 | 1 | |a Tolsma, Violaine |e investigator |4 oth | |
| 700 | 1 | |a Bougon, David |e investigator |4 oth | |
| 700 | 1 | |a Delbove, Agathe |e investigator |4 oth | |
| 700 | 1 | |a Gousseff, Marie |e investigator |4 oth | |
| 700 | 1 | |a Saidani, Nadia |e investigator |4 oth | |
| 700 | 1 | |a Wattecamps, Guilhem |e investigator |4 oth | |
| 700 | 1 | |a Djossou, Félix |e investigator |4 oth | |
| 700 | 1 | |a Epelboin, Loïc |e investigator |4 oth | |
| 700 | 1 | |a Lanoix, Jean-Philippe |e investigator |4 oth | |
| 700 | 1 | |a Roger, Pierre-Alexandre |e investigator |4 oth | |
| 700 | 1 | |a Andrejak, Claire |e investigator |4 oth | |
| 700 | 1 | |a Zerbib, Yoann |e investigator |4 oth | |
| 700 | 1 | |a Bouiller, Kevin |e investigator |4 oth | |
| 700 | 1 | |a Chirouze, Catherine |e investigator |4 oth | |
| 700 | 1 | |a Navellou, Jean-Christophe |e investigator |4 oth | |
| 700 | 1 | |a Boyer, Alexandre |e investigator |4 oth | |
| 700 | 1 | |a Cazanave, Charles |e investigator |4 oth | |
| 700 | 1 | |a Duvignaud, Alexandre |e investigator |4 oth | |
| 700 | 1 | |a Gruson, Didier |e investigator |4 oth | |
| 700 | 1 | |a Malvy, Denis |e investigator |4 oth | |
| 700 | 1 | |a Lessire, Henry |e investigator |4 oth | |
| 700 | 1 | |a Martinot, Martin |e investigator |4 oth | |
| 700 | 1 | |a Andreu, Pascal |e investigator |4 oth | |
| 700 | 1 | |a Blot, Mathieu |e investigator |4 oth | |
| 700 | 1 | |a Piroth, Lionel |e investigator |4 oth | |
| 700 | 1 | |a Quenot, Jean Pierre |e investigator |4 oth | |
| 700 | 1 | |a Epaulard, Olivier |e investigator |4 oth | |
| 700 | 1 | |a Terzi, Nicolas |e investigator |4 oth | |
| 700 | 1 | |a Faure, Karine |e investigator |4 oth | |
| 700 | 1 | |a Faure, Emmanuel |e investigator |4 oth | |
| 700 | 1 | |a Poissy, Julien |e investigator |4 oth | |
| 700 | 1 | |a Nseir, Saad |e investigator |4 oth | |
| 700 | 1 | |a Ader, Florence |e investigator |4 oth | |
| 700 | 1 | |a Argaud, Laurent |e investigator |4 oth | |
| 700 | 1 | |a Ferry, Tristan |e investigator |4 oth | |
| 700 | 1 | |a Perpoint, Thomas |e investigator |4 oth | |
| 700 | 1 | |a Piriou, Vincent |e investigator |4 oth | |
| 700 | 1 | |a Richard, Jean-Christophe |e investigator |4 oth | |
| 700 | 1 | |a Textoris, Julien |e investigator |4 oth | |
| 700 | 1 | |a Valour, Florent |e investigator |4 oth | |
| 700 | 1 | |a Wallet, Florent |e investigator |4 oth | |
| 700 | 1 | |a Cabié, André |e investigator |4 oth | |
| 700 | 1 | |a Turmel, Jean-Marie |e investigator |4 oth | |
| 700 | 1 | |a Chabartier, Cyrille |e investigator |4 oth | |
| 700 | 1 | |a Gaci, Rostane |e investigator |4 oth | |
| 700 | 1 | |a Robert, Céline |e investigator |4 oth | |
| 700 | 1 | |a Makinson, Alain |e investigator |4 oth | |
| 700 | 1 | |a Le Moing, Vincent |e investigator |4 oth | |
| 700 | 1 | |a Klouche, Kada |e investigator |4 oth | |
| 700 | 1 | |a Hinschberger, Olivier |e investigator |4 oth | |
| 700 | 1 | |a Mootien, Joy |e investigator |4 oth | |
| 700 | 1 | |a Gibot, Sébastien |e investigator |4 oth | |
| 700 | 1 | |a Goehringer, François |e investigator |4 oth | |
| 700 | 1 | |a Kimmoun, Antoine |e investigator |4 oth | |
| 700 | 1 | |a Lefevre, Benjamin |e investigator |4 oth | |
| 700 | 1 | |a Boutoille, David |e investigator |4 oth | |
| 700 | 1 | |a Canet, Emmanuel |e investigator |4 oth | |
| 700 | 1 | |a Gaborit, Benjamin |e investigator |4 oth | |
| 700 | 1 | |a Le Turnier, Paul |e investigator |4 oth | |
| 700 | 1 | |a Raffi, François |e investigator |4 oth | |
| 700 | 1 | |a Reignier, Jean |e investigator |4 oth | |
| 700 | 1 | |a Courjon, Johan |e investigator |4 oth | |
| 700 | 1 | |a Dellamonica, Jean |e investigator |4 oth | |
| 700 | 1 | |a Leroy, Sylvie |e investigator |4 oth | |
| 700 | 1 | |a Marquette, Charles-Hugo |e investigator |4 oth | |
| 700 | 1 | |a Loubet, Paul |e investigator |4 oth | |
| 700 | 1 | |a Roger, Claire |e investigator |4 oth | |
| 700 | 1 | |a Sotto, Albert |e investigator |4 oth | |
| 700 | 1 | |a Bruel, Cédric |e investigator |4 oth | |
| 700 | 1 | |a Pilmis, Benoît |e investigator |4 oth | |
| 700 | 1 | |a Geri, Guillaume |e investigator |4 oth | |
| 700 | 1 | |a Rouveix-Nordon, Elisabeth |e investigator |4 oth | |
| 700 | 1 | |a Bouchaud, Olivier |e investigator |4 oth | |
| 700 | 1 | |a Figueiredo, Samy |e investigator |4 oth | |
| 700 | 1 | |a Jaureguiberry, Stéphane |e investigator |4 oth | |
| 700 | 1 | |a Monnet, Xavier |e investigator |4 oth | |
| 700 | 1 | |a Bouadma, Lila |e investigator |4 oth | |
| 700 | 1 | |a Lescure, François-Xavier |e investigator |4 oth | |
| 700 | 1 | |a Peiffer-Smadja, Nathan |e investigator |4 oth | |
| 700 | 1 | |a Timsit, Jean-François |e investigator |4 oth | |
| 700 | 1 | |a Yazdanpanah, Yazdan |e investigator |4 oth | |
| 700 | 1 | |a Kerneis, Solen |e investigator |4 oth | |
| 700 | 1 | |a Lachâtre, Marie |e investigator |4 oth | |
| 700 | 1 | |a Launay, Odile |e investigator |4 oth | |
| 700 | 1 | |a Mira, Jean-Paul |e investigator |4 oth | |
| 700 | 1 | |a Mayaux, Julien |e investigator |4 oth | |
| 700 | 1 | |a Pourcher, Valérie |e investigator |4 oth | |
| 700 | 1 | |a Aboab, Jérôme |e investigator |4 oth | |
| 700 | 1 | |a Crockett, Flora |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical infectious diseases : an official publication of the Infectious Diseases Society of America |d 1992 |g (2024) vom: 29. März |w (DE-627)NLM012603007 |x 1537-6591 |7 nnns |
| 773 | 1 | 8 | |g year:2024 |g day:29 |g month:03 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/cid/ciae170 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 29 |c 03 | ||