Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns.
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(R), 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 September 2020 were included. We conducted disproportionality analyses allowing the estimation of reporting odds ratios (RORs) with 95% CI.
RESULTS: We found 302 cardiac effects including 94 bradycardia (31%) among the 2603 reports with remdesivir prescribed in COVID-19 patients. Most of the 94 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.
DISCUSSION: 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 the pharmacodynamic properties of remdesivir.
|ジャーナル名||Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases|
|投稿者||Touafchia, Anthony; Bagheri, Haleh; Carrie, Didier; Durrieu, Genevieve; Sommet, Agnes; Chouchana, Laurent; Montastruc, Francois|
|組織名||Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and;Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine,;Toulouse, France; Department of Cardiology, Toulouse University Hospital (CHU),;Faculty of Medicine, Toulouse, France.;Toulouse, France; CIC 1436, Team PEPSS << Pharmacologie En Population cohorteS et;biobanqueS >>, Toulouse University Hospital, France.;Department of Cardiology, Toulouse University Hospital (CHU), Faculty of;Medicine, Toulouse, France.;Department of Pharmacology, Regional Pharmacovigilance Center, Cochin Hospital,;AP-HP.Centre - Universite de Paris. Paris, France.;Medicine, Toulouse, France. Electronic address:;email@example.com.|