Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).
Identifieur interne : 000353 ( Main/Corpus ); précédent : 000352; suivant : 000354Pharmacotherapy Management for COVID-19 and Cardiac Safety: A Data Mining Approach for Pharmacovigilance Evidence from the FDA Adverse Event Reporting System (FAERS).
Auteurs : Jing Yuan ; Minghui Li ; Yiqun Yu ; Tai-Ying Lee ; Gang Lv ; Bing Han ; Xiaoqiang Xiang ; Z Kevin LuSource :
- Drugs - real world outcomes [ 2199-1154 ] ; 2021.
Abstract
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.
DOI: 10.1007/s40801-021-00229-8
PubMed: 33569736
PubMed Central: PMC7875167
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pubmed:33569736Le document en format XML
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<affiliation><nlm:affiliation>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China.</nlm:affiliation>
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<author><name sortKey="Li, Minghui" sort="Li, Minghui" uniqKey="Li M" first="Minghui" last="Li">Minghui Li</name>
<affiliation><nlm:affiliation>University of Tennessee Health Science Center, Memphis, TN, USA.</nlm:affiliation>
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<author><name sortKey="Yu, Yiqun" sort="Yu, Yiqun" uniqKey="Yu Y" first="Yiqun" last="Yu">Yiqun Yu</name>
<affiliation><nlm:affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</nlm:affiliation>
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<author><name sortKey="Lee, Tai Ying" sort="Lee, Tai Ying" uniqKey="Lee T" first="Tai-Ying" last="Lee">Tai-Ying Lee</name>
<affiliation><nlm:affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA.</nlm:affiliation>
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<author><name sortKey="Lv, Gang" sort="Lv, Gang" uniqKey="Lv G" first="Gang" last="Lv">Gang Lv</name>
<affiliation><nlm:affiliation>General Surgery Department, 1st Medical Center of PLA General Hospital, Beijing, China.</nlm:affiliation>
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<author><name sortKey="Han, Bing" sort="Han, Bing" uniqKey="Han B" first="Bing" last="Han">Bing Han</name>
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<author><name sortKey="Xiang, Xiaoqiang" sort="Xiang, Xiaoqiang" uniqKey="Xiang X" first="Xiaoqiang" last="Xiang">Xiaoqiang Xiang</name>
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<author><name sortKey="Lu, Z Kevin" sort="Lu, Z Kevin" uniqKey="Lu Z" first="Z Kevin" last="Lu">Z Kevin Lu</name>
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<author><name sortKey="Li, Minghui" sort="Li, Minghui" uniqKey="Li M" first="Minghui" last="Li">Minghui Li</name>
<affiliation><nlm:affiliation>University of Tennessee Health Science Center, Memphis, TN, USA.</nlm:affiliation>
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<author><name sortKey="Yu, Yiqun" sort="Yu, Yiqun" uniqKey="Yu Y" first="Yiqun" last="Yu">Yiqun Yu</name>
<affiliation><nlm:affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</nlm:affiliation>
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<author><name sortKey="Lee, Tai Ying" sort="Lee, Tai Ying" uniqKey="Lee T" first="Tai-Ying" last="Lee">Tai-Ying Lee</name>
<affiliation><nlm:affiliation>University of South Carolina, 715 Sumter Street, CLS Building 311, Columbia, SC, 29208, USA.</nlm:affiliation>
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<author><name sortKey="Lv, Gang" sort="Lv, Gang" uniqKey="Lv G" first="Gang" last="Lv">Gang Lv</name>
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<author><name sortKey="Han, Bing" sort="Han, Bing" uniqKey="Han B" first="Bing" last="Han">Bing Han</name>
<affiliation><nlm:affiliation>Department of Pharmacy, Minhang Hospital, Fudan University, Shanghai, People's Republic of China.</nlm:affiliation>
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<author><name sortKey="Xiang, Xiaoqiang" sort="Xiang, Xiaoqiang" uniqKey="Xiang X" first="Xiaoqiang" last="Xiang">Xiaoqiang Xiang</name>
<affiliation><nlm:affiliation>Department of Clinical Pharmacy, School of Pharmacy, Fudan University, 826 Zhangheng Road, Pudong, Shanghai, 201203, People's Republic of China. xiangxq@fudan.edu.cn.</nlm:affiliation>
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<author><name sortKey="Lu, Z Kevin" sort="Lu, Z Kevin" uniqKey="Lu Z" first="Z Kevin" last="Lu">Z Kevin Lu</name>
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<series><title level="j">Drugs - real world outcomes</title>
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<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>PATIENTS AND METHODS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>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.</p>
</div>
</front>
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<Abstract><AbstractText Label="BACKGROUND" NlmCategory="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.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="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.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
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