tetano
Editor, Senior Moderator
Clin Infect Dis
. 2024 Mar 29:ciae170.
doi: 10.1093/cid/ciae170. Online ahead of print. Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial
Vida Terzić[SUP] 1 2 [/SUP], Joe Miantezila Basilua[SUP] 1 2 [/SUP], Nicolas Billard[SUP] 3 [/SUP], Lucie de Gastines[SUP] 1 2 [/SUP], Drifa Belhadi[SUP] 3 4 [/SUP], Claire Fougerou-Leurent[SUP] 5 [/SUP], Nathan Peiffer-Smadja[SUP] 6 4 [/SUP], Noémie Mercier[SUP] 1 2 [/SUP], Christelle Delmas[SUP] 7 [/SUP], Assia Ferrane[SUP] 7 [/SUP], Aline Dechanet[SUP] 3 [/SUP], Julien Poissy[SUP] 8 [/SUP], Hélène Espérou[SUP] 7 [/SUP], Florence Ader[SUP] 9 [/SUP], Maya Hites[SUP] 10 [/SUP], Claire Andrejak[SUP] 11 [/SUP], Richard Greil[SUP] 12 [/SUP], José-Artur Paiva[SUP] 13 [/SUP], Thérèse Staub[SUP] 14 [/SUP], Evelina Tacconelli[SUP] 15 [/SUP], Charles Burdet[SUP] 3 [/SUP], Dominique Costagliola[SUP] 16 [/SUP], France Mentré[SUP] 3 4 [/SUP], Yazdan Yazdanpanah[SUP] 5 6 17 [/SUP], Alpha Diallo[SUP] 1 2 [/SUP]; DisCoVeRy study group
Collaborators, Affiliations
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.
Keywords: COVID-19; antiviral therapy; cardiac adverse events; randomized controlled trials; remdesivir.
. 2024 Mar 29:ciae170.
doi: 10.1093/cid/ciae170. Online ahead of print. Cardiac Adverse Events and Remdesivir in Hospitalized Patients with Coronavirus Disease 2019 (COVID-19): A Post Hoc Safety Analysis of the Randomized DisCoVeRy Trial
Vida Terzić[SUP] 1 2 [/SUP], Joe Miantezila Basilua[SUP] 1 2 [/SUP], Nicolas Billard[SUP] 3 [/SUP], Lucie de Gastines[SUP] 1 2 [/SUP], Drifa Belhadi[SUP] 3 4 [/SUP], Claire Fougerou-Leurent[SUP] 5 [/SUP], Nathan Peiffer-Smadja[SUP] 6 4 [/SUP], Noémie Mercier[SUP] 1 2 [/SUP], Christelle Delmas[SUP] 7 [/SUP], Assia Ferrane[SUP] 7 [/SUP], Aline Dechanet[SUP] 3 [/SUP], Julien Poissy[SUP] 8 [/SUP], Hélène Espérou[SUP] 7 [/SUP], Florence Ader[SUP] 9 [/SUP], Maya Hites[SUP] 10 [/SUP], Claire Andrejak[SUP] 11 [/SUP], Richard Greil[SUP] 12 [/SUP], José-Artur Paiva[SUP] 13 [/SUP], Thérèse Staub[SUP] 14 [/SUP], Evelina Tacconelli[SUP] 15 [/SUP], Charles Burdet[SUP] 3 [/SUP], Dominique Costagliola[SUP] 16 [/SUP], France Mentré[SUP] 3 4 [/SUP], Yazdan Yazdanpanah[SUP] 5 6 17 [/SUP], Alpha Diallo[SUP] 1 2 [/SUP]; DisCoVeRy study group
Collaborators, Affiliations
- PMID: 38552208
- DOI: 10.1093/cid/ciae170
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.
Keywords: COVID-19; antiviral therapy; cardiac adverse events; randomized controlled trials; remdesivir.