Cardiovascular Safety of Azithromycin in Patients Hospitalized With COVID-19: A Prespecified Pooled Analysis of the COALITION I and COALITION II Randomized Clinical Trials
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Tipo de produção
article
Data de publicação
2024
Título da Revista
ISSN da Revista
Título do Volume
Editora
EXCERPTA MEDICA INC-ELSEVIER SCIENCE INC
Autores
SILVA, Pedro G. M. Barros e
FONSECA, Henrique A. R.
SERPA-NETO, Ary
CORREA, Thiago D.
GUIMARAES, Helio P.
PEREIRA, Adriano J.
OLIVATO, Guilherme B.
ZAMPIERI, Fernando G.
LISBOA, Thiago
Citação
AMERICAN JOURNAL OF CARDIOLOGY, v.214, p.18-24, 2024
Resumo
The cardiovascular safety from azithromycin in the treatment of several infectious diseases has been challenged. In this prespecified pooled analysis of 2 multicenter randomized clinical trials, we aimed to assess whether the use of azithromycin might lead to corrected QT (QTc) interval prolongation or clinically relevant ventricular arrhythmias. In the COALITION COVID Brazil I trial, 667 patients admitted with moderate COVID-19 were randomly allocated to hydroxychloroquine, hydroxychloroquine plus azithromycin, or standard of care. In the COALITION COVID Brazil II trial, 447 patients with severe COVID-19 were randomly allocated to hydroxychloroquine alone versus hydroxychloroquine plus azithromycin. The principal end point for the present analysis was the composite of death, resuscitated cardiac arrest, or ventricular arrhythmias. The addition of azithromycin to hydroxychloroquine did not result in any prolongation of the QTc interval (425.8 +/- 3.6 ms vs 427.9 +/- 3.9 ms, respectively, mean difference -2.1 ms, 95% confidence interval -12.5 to 8.4 ms, p = 0.70). The combination of azithromycin plus hydroxychloroquine compared with hydroxychloroquine alone did not result in increased risk of the primary end point (proportion of patients with events at 15 days 17.2% vs 16.0%, respectively, hazard ratio 1.08, 95% confidence interval 0.78 to 1.49, p = 0.65). In conclusion, in patients hospitalized with COVID-19 already receiving standardof-care management (including hydroxychloroquine), the addition of azithromycin did not result in the prolongation of the QTc interval or increase in cardiovascular adverse events. Because azithromycin is among the most commonly prescribed antimicrobial agents, our results may inform clinical practice. Clinical Trial Registration: NCT04322123, NCT04321278.
Palavras-chave
COVID-19, hydroxychloroquine, azithromycin, QTc interval prolongation, cardiac, arrhythmia, cardiac arrest
Referências
- Antzelevitch C, 1996, J AM COLL CARDIOL, V28, P1836, DOI 10.1016/S0735-1097(96)00377-4
- Cavalcanti AB, 2020, NEW ENGL J MED, V383, P2041, DOI 10.1056/NEJMoa2019014
- Centers for Disease Control and Prevention, Outpatient antibiotic prescriptions-United States, 2022
- Cheng YJ, 2015, J AM COLL CARDIOL, V66, P2173, DOI 10.1016/j.jacc.2015.09.029
- Chorin E, 2020, NAT MED, V26, P808, DOI 10.1038/s41591-020-0888-2
- Division of STD Prevention National Center for HIV, Viral hepatitis, STD, and TB prevention
- Furtado RHM, 2020, LANCET, V396, P959, DOI 10.1016/S0140-6736(20)31862-6
- Halpin DMG, 2021, AM J RESP CRIT CARE, V203, P24, DOI 10.1164/rccm.202009-3533SO
- Hiatt WR, 2013, NEW ENGL J MED, V369, P1285, DOI 10.1056/NEJMp1309610
- Horby PW, 2021, LANCET, V397, P1637, DOI 10.1016/S0140-6736(21)00676-0
- Jespersen CM, 2006, BRIT MED J, V332, P22, DOI 10.1136/bmj.38666.653600.55
- Little R.J.A., 2002, STAT ANAL MISSING DA, DOI [DOI 10.1002/9781119013563.CH10, DOI 10.1002/9781119013563]
- Metlay JP, 2019, AM J RESP CRIT CARE, V200, pE45, DOI 10.1164/rccm.201908-1581ST
- Mortensen EM, 2014, JAMA-J AM MED ASSOC, V311, P2199, DOI 10.1001/jama.2014.4304
- Nguyen LS, 2020, CIRCULATION, V142, P303, DOI 10.1161/CIRCULATIONAHA.120.048238
- Ray WA, 2012, NEW ENGL J MED, V366, P1881, DOI 10.1056/NEJMc1207269
- Svanström H, 2013, NEW ENGL J MED, V368, P1704, DOI 10.1056/NEJMoa1300799
- Tisdale JE, 2020, CIRCULATION, V142, pE214, DOI 10.1161/CIR.0000000000000905