Conv. Plasma
Nigella Sativa

All remdesivir studies
Meta analysis
study COVID-19 treatment researchRemdesivirRemdesivir (more..)
Melatonin Meta
Metformin Meta
Azvudine Meta
Bromhexine Meta Molnupiravir Meta
Budesonide Meta
Colchicine Meta
Conv. Plasma Meta Nigella Sativa Meta
Curcumin Meta Nitazoxanide Meta
Famotidine Meta Paxlovid Meta
Favipiravir Meta Quercetin Meta
Fluvoxamine Meta Remdesivir Meta
Hydroxychlor.. Meta Thermotherapy Meta
Ivermectin Meta

All Studies   Meta Analysis    Recent:   

Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns

Touafchia et al., Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.02.013
Feb 2021  
  Source   PDF   All Studies   Meta AnalysisMeta
Comparison of bradycardia in COVID-19 patients treated with remdesivir compared to those treated with HCQ, lopinavir/ritonavir, tocilizumab or glucocorticoids, finding increased risk of bradycardia with remdesivir.
Touafchia et al., 27 Feb 2021, peer-reviewed, 6 authors.
This PaperRemdesivirAll
Serious bradycardia and remdesivir for coronavirus 2019 (COVID-19): a new safety concerns
Anthony Touafchia, Haleh Bagheri, Didier Carrié, Geneviève Durrieu, Agnès Sommet, Laurent Chouchana, François Montastruc
Clinical Microbiology and Infection, doi:10.1016/j.cmi.2021.02.013
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 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 1.23e2.22). 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.
Author contributions All authors conceived and designed the study. F.M. and A.T. acquired the data and did the statistical analyses. All authors analysed and interpreted the data. F.M. wrote the manuscript, and all authors critically revised the manuscript. F.M. supervised the study and is the guarantor. All authors approved the final version of the manuscript and are accountable for its accuracy.
Ahmad, Yin, Saffitz, Pockros, Lalezari et al., Cardiac dysfunction associated with a nucleotide polymerase inhibitor for treatment of hepatitis C, Hepatology, doi:10.1002/hep.27488
Beigel, Tomashek, Dodd, Mehta, Zingman et al., Remdesivir for the treatment of covid-19 e final report, N Engl J Med, doi:10.1056/NEJMoa2007764
Coloma, Trifir O G, Patadia, Sturkenboom, Postmarketing safety surveillance: where does signal detection using electronic healthcare records fit into the big picture?, Drug Saf, doi:10.1007/s40264-013-0018-x
Fontaine, Pol, Pecriaux, Bagate, Sultanik, Bradyarrhythmias associated with sofosbuvir treatment, N Engl J Med, doi:10.1056/NEJMc1505967
Gagne, Finding meaningful patterns in adverse drug event reports, JAMA Intern Med, doi:10.1001/jamainternmed.2014.3270
Goldman, Bomze, Dankner, Hod, Meirson et al., Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: a comprehensive pharmacovigilance analysis of pre-COVID-19 reports, Br J Clin Pharmacol, doi:10.1111/bcp.14546
Gordon, Tchesnokov, Woolner, Perry, Feng et al., Remdesivir is a direct-acting antiviral that inhibits RNA-dependent RNA polymerase from severe acute respiratory syndrome coronavirus 2 with high potency, J Biol Chem, doi:10.1074/jbc.RA120.013679
Michaud, Dow, Rihani, Deodhar, Arwood et al., Risk assessment of drug-induced long QT syndrome for some COVID-19 repurposed drugs, Clin Transl Sci, doi:10.1111/cts.12882
Montastruc, Thuriot, Durrieu, Hepatic disorders with the use of remdesivir for coronavirus 2019, Clin Gastroenterol Hepatol, doi:10.1016/j.cgh.2020.07.050
Mulangu, Dodd, Davey, Mbaya, Proschan et al., A randomized, controlled trial of Ebola virus disease therapeutics, N Engl J Med, doi:10.1056/NEJMoa1910993
Onakpoya, Rare adverse events in clinical trials: understanding the rule of three, BMJ Evid Based Med, doi:10.1136/ebmed-2017-110885
Pelleg, Belhassen, The mechanism of the negative chronotropic and dromotropic actions of adenosine 5'-triphosphate in the heart: an update, J Cardiovasc Pharmacol, doi:10.1097/FJC.0b013e3181e0f8b2
Regan, Morissette, Regan, Travis, Gerenser et al., Assessment of the clinical cardiac drug-drug interaction associated with the combination of hepatitis C virus nucleotide inhibitors and amiodarone in Guinea pigs and rhesus monkeys, Hepatology, doi:10.1002/hep.28752
Rihani, Smith, Bikmetov, Deodhar, Dow et al., Risk of adverse drug events following the virtual addition of covid-19 repurposed drugs to drug regimens of frail older adults with polypharmacy, J Clin Med, doi:10.3390/jcm9082591
Wang, Zhang, Du, Du, Zhao et al., Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial, Lancet, doi:10.1016/S0140-6736(20)31022-9
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
  or use drag and drop