tetano
Editor, Senior Moderator
Clin Microbiol Infect
. 2021 Feb 26;S1198-743X(21)00094-X.
doi: 10.1016/j.cmi.2021.02.013. Online ahead of print.
Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns
Anthony Touafchia[SUP] 1 [/SUP], Haleh Bagheri[SUP] 2 [/SUP], Didier Carri?[SUP] 3 [/SUP], Genevi?ve Durrieu[SUP] 2 [/SUP], Agn?s Sommet[SUP] 2 [/SUP], Fran?ois Montastruc[SUP] 4 [/SUP]
Affiliations
Abstract
Objectives: In recent clinical trials some cardiac arrhythmias were reported with use of remdesivir for COVID-19. To address this safety concern, we investigated whether use of remdesivir for COVID-19 is associated with an increased risk of bradycardia.
Methods: Using VigiBase?, the World Health Organization Global Individual Case Safety Reports database, we compared the cases of bradycardia reported in COVID-19 patients exposed to remdesivir with those reported in COVID-19 patients exposed to hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. All reports of patients with COVID-19 registered up to the 23[SUP]th[/SUP] of September 2020 were included. We conducted disproportionality analyses allowing the estimation of reporting odds ratios (RORs) with 95% Confident Intervals (95% CI).
Results: We found 302 cardiac effects including 94 bradycardia (31%) among the 2,603 reports with remdesivir prescribed in COVID-19 patients. Most of reports were serious (75, 80%) and in 16 reports (17%) evolution was fatal. Compared with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids, the use of remdesivir was associated with an increased risk of reporting bradycardia (ROR 1.65; 95% CI 1.23, 2.22). Consistent results were observed in other sensitivity analyses.
Conclusions: This post-marketing study in a real-world setting suggests that the use of remdesivir is significantly associated with an increased risk of reporting bradycardia and serious bradycardia when compared with the use of with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. This result is in line with pharmacodynamic properties of the remdesivir.
. 2021 Feb 26;S1198-743X(21)00094-X.
doi: 10.1016/j.cmi.2021.02.013. Online ahead of print.
Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns
Anthony Touafchia[SUP] 1 [/SUP], Haleh Bagheri[SUP] 2 [/SUP], Didier Carri?[SUP] 3 [/SUP], Genevi?ve Durrieu[SUP] 2 [/SUP], Agn?s Sommet[SUP] 2 [/SUP], Fran?ois Montastruc[SUP] 4 [/SUP]
Affiliations
- PMID: 33647441
- DOI: 10.1016/j.cmi.2021.02.013
Abstract
Objectives: In recent clinical trials some cardiac arrhythmias were reported with use of remdesivir for COVID-19. To address this safety concern, we investigated whether use of remdesivir for COVID-19 is associated with an increased risk of bradycardia.
Methods: Using VigiBase?, the World Health Organization Global Individual Case Safety Reports database, we compared the cases of bradycardia reported in COVID-19 patients exposed to remdesivir with those reported in COVID-19 patients exposed to hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. All reports of patients with COVID-19 registered up to the 23[SUP]th[/SUP] of September 2020 were included. We conducted disproportionality analyses allowing the estimation of reporting odds ratios (RORs) with 95% Confident Intervals (95% CI).
Results: We found 302 cardiac effects including 94 bradycardia (31%) among the 2,603 reports with remdesivir prescribed in COVID-19 patients. Most of reports were serious (75, 80%) and in 16 reports (17%) evolution was fatal. Compared with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids, the use of remdesivir was associated with an increased risk of reporting bradycardia (ROR 1.65; 95% CI 1.23, 2.22). Consistent results were observed in other sensitivity analyses.
Conclusions: This post-marketing study in a real-world setting suggests that the use of remdesivir is significantly associated with an increased risk of reporting bradycardia and serious bradycardia when compared with the use of with hydroxychloroquine, lopinavir/ritonavir, tocilizumab or glucocorticoids. This result is in line with pharmacodynamic properties of the remdesivir.