| アブストラクト | BACKGROUND: The use of hydroxychloroquine or chloroquine (HCQ/CQ) as monotherapy or combined with azithromycin for the treatment of coronavirus disease 2019 (COVID-19) may increase the risk of serious cardiovascular adverse events (SCAEs). OBJECTIVE: Our objective was to describe and evaluate the risk of SCAEs with HCQ/CQ as monotherapy or combined with azithromycin compared with that for therapeutic alternatives. METHODS: We performed a disproportionality analysis and descriptive case series using the US FDA Adverse Event Reporting System. RESULTS: Compared with remdesivir, HCQ/CQ was associated with increased reporting of SCAEs (reporting odds ratio [ROR] 2.1; 95% confidence interval [CI] 1.8-2.5), torsade de pointes (TdP)/QTc prolongation (ROR 35.4; 95% CI 19.4-64.5), and ventricular arrhythmia (ROR 2.5; 95% CI 1.6-3.9); similar results were found in comparison with other therapeutic alternatives. Compared with lopinavir/ritonavir, HCQ/CQ was associated with increased reporting of ventricular arrhythmia (ROR 10.5; 95% CI 3.3-33.4); RORs were larger when HCQ/CQ was used in combination with azithromycin. In 2020, 312 of the 575 reports of SCAEs listed concomitant use of HCQ/CQ and azithromycin, including QTc prolongation (61.4%), ventricular arrhythmia (12.0%), atrial fibrillation (8.2%), TdP (4.9%), and cardiac arrest (4.4%); 88 (15.3%) cases resulted in hospitalization and 79 (13.7%) resulted in death. In total, 122 fatal QTc prolongation-related cardiovascular reports were associated with 1.4 times higher odds of reported death than those induced by SCAEs; 87 patients received more than one QTc-prolonging agent. CONCLUSIONS: Patients treated with HCQ/CQ monotherapy or HCQ/CQ + azithromycin may be at increased risk of SCAEs, TdP/QTc prolongation, and ventricular arrhythmia. Cardiovascular risks need to be considered when evaluating the benefit/harm balance of treatment with HCQ/CQ, especially with the concurrent use of QTc-prolonging agents and cytochrome P450 3A4 inhibitors when treating COVID-19. |
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| 投稿者 | Zhao, Ying; Zhang, Jingru; Zheng, Kai; Thai, Sydney; Simpson, Ross J Jr; Kinlaw, Alan C; Xu, Yang; Wei, Jingkai; Cui, Xiangli; Buse, John B; Sturmer, Til; Wang, Tiansheng |
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| 組織名 | Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University,;Beijing, China.;Department of Biostatistics, University of North Carolina at Chapel Hill Gillings;School of Global Public Health, Chapel Hill, USA.;Department of Pharmacy, Beijing Cancer Hospital, Beijing, China.;Department of Epidemiology, Gillings School of Global Public Health, University;of North Carolina at Chapel Hill, 2101 McGavran-Greenberg Hall, Campus Box 7453,;Chapel Hill, 27599, USA.;Department of Medicine, University of North Carolina at Chapel Hill School of;Medicine, Chapel Hill, USA.;Department of Pharmaceutical Outcomes and Policy, University of North Carolina;School of Pharmacy, Chapel Hill, USA.;Cecil G. Sheps Center for Health Services Research, University of North Carolina;at Chapel Hill, Chapel Hill, USA.;Peking University Clinical Research Institute, Peking University First Hospital,;Department of Epidemiology and Biostatistics, Arnold School of Public Health,;University of South Carolina, Columbia, USA.;Chapel Hill, 27599, USA. tianwang@unc.edu. |
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