| アブストラクト | BACKGROUND: Several pharmacological agents, such as chloroquine/hydroxychloroquine, have been promoted for COVID-19 treatment or pre-exposure prophylaxis. However, no comprehensive evaluation of the safety of these possible agents is available, and is urgently needed. OBJECTIVE: The purpose of this study was to investigate the risks of cardiac adverse events associated with the possible pharmacotherapies for COVID-19, including certain antimalarial, antiviral, and antibiotic drugs. PATIENTS AND METHODS: We conduced retrospective pharmacovigilance analyses of the US Food and Drug Administration Adverse Event Reporting System database. The reporting odds ratio (ROR), a data mining algorithm commonly used in pharmacovigilance assessment, was generated to quantify the detection signal of adverse events. RESULTS: Among individuals without coronavirus infection from 2015 Q1 to 2020 Q1, increased risks for cardiac disorders were found for antiviral agents such as chloroquine/hydroxychloroquine (ROR: 1.68; 95% confidence interval [CI] 1.66-1.70), lopinavir/ritonavir (ROR: 1.52; 95% CI 1.39-1.66), and antibiotics such as azithromycin (ROR: 1.37; 95% CI 1.30-1.44) and ceftriaxone (ROR: 1.92; 95% CI 1.80-2.05). Increased serious cardiac adverse events, including myocardial infarction, arrhythmia, and cardiac arrest, were also reported for these drugs. Further analyses of individuals with coronavirus infections revealed that 40% of individuals receiving chloroquine/hydroxychloroquine reported serious cardiac adverse events. Two cases resulted in QT prolongations and one case resulted in cardiac arrest. Chloroquine/hydroxychloroquine and azithromycin contributed to all the QT prolongation and cardiac arrest cases. CONCLUSIONS: The current pharmacotherapies for COVID-19 are associated with increased risks of cardiac adverse events. Variations in the cardiac safety profiles of these pharmacotherapies were also observed. Clinicians should closely monitor patients with COVID-19, especially those at high risk, using chloroquine/hydroxychloroquine and azithromycin. |
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| ジャーナル名 | Drugs - real world outcomes |
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| 投稿日 | 2021/2/12 |
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| 投稿者 | Yuan, Jing; Li, Minghui; Yu, Yiqun; Lee, Tai-Ying; Lv, Gang; Han, Bing; Xiang, Xiaoqiang; Lu, Z Kevin |
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| 組織名 | Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826;Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China.;University of Tennessee Health Science Center, Memphis, TN, USA.;Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's;Republic of China.;University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC,;29208, USA.;General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing,;China.;xiangxq@fudan.edu.cn.;29208, USA. lu32@email.sc.edu. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33569736/ |
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