A pharmacovigilance study to quantify the strength of association between the combination of antimalarial drugs and azithromycin and cardiac arrhythmias: implications for the treatment of COVID-19.
Identifieur interne : 000841 ( Main/Corpus ); précédent : 000840; suivant : 000842A pharmacovigilance study to quantify the strength of association between the combination of antimalarial drugs and azithromycin and cardiac arrhythmias: implications for the treatment of COVID-19.
Auteurs : Vakaramoko Diaby ; Reem D. Almutairi ; Ziyan Chen ; Richard K. Moussa ; Abdrahmane BertheSource :
- Expert review of pharmacoeconomics & outcomes research [ 1744-8379 ] ; 2021.
English descriptors
- KwdEn :
- Adverse Drug Reaction Reporting Systems (MeSH), Anti-Bacterial Agents (adverse effects), Anti-Bacterial Agents (therapeutic use), Antimalarials (adverse effects), Antimalarials (therapeutic use), Arrhythmias, Cardiac (chemically induced), Azithromycin (adverse effects), Azithromycin (therapeutic use), COVID-19 (drug therapy), Drug Therapy, Combination (MeSH), Electrocardiography (drug effects), Humans (MeSH), Long QT Syndrome (chemically induced), Long QT Syndrome (epidemiology), Pharmacovigilance (MeSH), Torsades de Pointes (chemically induced), Torsades de Pointes (epidemiology), United States (MeSH), United States Food and Drug Administration (MeSH).
- MESH :
- chemical , adverse effects : Anti-Bacterial Agents, Antimalarials, Azithromycin.
- chemical , therapeutic use : Anti-Bacterial Agents, Antimalarials, Azithromycin.
- geographic : United States.
- chemically induced : Arrhythmias, Cardiac, Long QT Syndrome, Torsades de Pointes.
- drug effects : Electrocardiography.
- drug therapy : COVID-19.
- epidemiology : Long QT Syndrome, Torsades de Pointes.
- Adverse Drug Reaction Reporting Systems, Drug Therapy, Combination, Humans, Pharmacovigilance, United States Food and Drug Administration.
Abstract
Background: Hydroxychloroquine, an antimalarial drug, combined with azithromycin has been considered a potential treatment for COVID-19. However, these drugs may cause electrocardiogram QT prolongation (QTp) and torsade de Pointes (TdP). We examined potential safety signals for these cardiac arrhythmias. Methods: Using the OpenVigil 2.1 MedDRA platform, we mined data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) from December 2019 to June 2020. We extracted individual case safety reports based on exposures of seven antimalarial drugs, azithromycin, and combinations. All other drugs in FAERS served as controls. Events of interest included QTp and TdP, with associations between drug exposures and events expressed as adjusted Reporting-Odds-Ratios (aRORs) and confidence intervals. The lower end of aROR 95% confidence interval >1 was used as the statistically significant signal detection threshold. Results: QTp safety signals were found for hydroxychloroquine[aROR:11.70 (10.40-13.16)], chloroquine[aROR:18.97 (11.30-31.87)], quinine[aROR:16.66 (10.18-27.25)], atovaquone[aROR:6.91 (4.14-11.56)], azithromycin alone [aROR:28.02 (22.87-34.32)] and hydroxychloroquine + azithromycin [aROR:75.23 (51.15-110.66)]. TdP safety signals were found for hydroxychloroquine [aROR: 5.62 (4.94-6.38)], chloroquine[aROR:49.37 (30.63-79.58)], and hydroxychloroquine + azithromycin[aROR:33.09 (21.22-51.61)]. Conclusion: Hydroxychloroquine/chloroquine and/or azithromycin was associated with QTp/TdP safety signals and their use should be monitored carefully.
DOI: 10.1080/14737167.2021.1851600
PubMed: 33186061
PubMed Central: PMC7738207
Links to Exploration step
pubmed:33186061Le document en format XML
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Almutairi</name><affiliation><nlm:affiliation>Department of Pharmaceutical Business and Administration Sciences, MCPHS University , Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Ziyan" sort="Chen, Ziyan" uniqKey="Chen Z" first="Ziyan" last="Chen">Ziyan Chen</name><affiliation><nlm:affiliation>College of Pharmacy, HPNP 3317, University of Florida , Gainesville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Moussa, Richard K" sort="Moussa, Richard K" uniqKey="Moussa R" first="Richard K" last="Moussa">Richard K. Moussa</name><affiliation><nlm:affiliation>Théorie Économique, Modélisation et Applications (ThEMA), Université de Cergy-Pontoise, France and Ecole Nationale Supérieure de Statistiques et d'Economie Appliquée (ENSEA).</nlm:affiliation></affiliation></author><author><name sortKey="Berthe, Abdrahmane" sort="Berthe, Abdrahmane" uniqKey="Berthe A" first="Abdrahmane" last="Berthe">Abdrahmane Berthe</name><affiliation><nlm:affiliation>Northwest Territories Government , Yellowknife, Canada.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33186061</idno><idno type="pmid">33186061</idno><idno type="doi">10.1080/14737167.2021.1851600</idno><idno type="pmc">PMC7738207</idno><idno type="wicri:Area/Main/Corpus">000841</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000841</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A pharmacovigilance study to quantify the strength of association between the combination of antimalarial drugs and azithromycin and cardiac arrhythmias: implications for the treatment of COVID-19.</title><author><name sortKey="Diaby, Vakaramoko" sort="Diaby, Vakaramoko" uniqKey="Diaby V" first="Vakaramoko" last="Diaby">Vakaramoko Diaby</name><affiliation><nlm:affiliation>College of Pharmacy, HPNP 3317, University of Florida , Gainesville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Almutairi, Reem D" sort="Almutairi, Reem D" uniqKey="Almutairi R" first="Reem D" last="Almutairi">Reem D. Almutairi</name><affiliation><nlm:affiliation>Department of Pharmaceutical Business and Administration Sciences, MCPHS University , Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Chen, Ziyan" sort="Chen, Ziyan" uniqKey="Chen Z" first="Ziyan" last="Chen">Ziyan Chen</name><affiliation><nlm:affiliation>College of Pharmacy, HPNP 3317, University of Florida , Gainesville, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Moussa, Richard K" sort="Moussa, Richard K" uniqKey="Moussa R" first="Richard K" last="Moussa">Richard K. Moussa</name><affiliation><nlm:affiliation>Théorie Économique, Modélisation et Applications (ThEMA), Université de Cergy-Pontoise, France and Ecole Nationale Supérieure de Statistiques et d'Economie Appliquée (ENSEA).</nlm:affiliation></affiliation></author><author><name sortKey="Berthe, Abdrahmane" sort="Berthe, Abdrahmane" uniqKey="Berthe A" first="Abdrahmane" last="Berthe">Abdrahmane Berthe</name><affiliation><nlm:affiliation>Northwest Territories Government , Yellowknife, Canada.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Expert review of pharmacoeconomics & outcomes research</title><idno type="eISSN">1744-8379</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adverse Drug Reaction Reporting Systems (MeSH)</term><term>Anti-Bacterial Agents (adverse effects)</term><term>Anti-Bacterial Agents (therapeutic use)</term><term>Antimalarials (adverse effects)</term><term>Antimalarials (therapeutic use)</term><term>Arrhythmias, Cardiac (chemically induced)</term><term>Azithromycin (adverse effects)</term><term>Azithromycin (therapeutic use)</term><term>COVID-19 (drug therapy)</term><term>Drug Therapy, Combination (MeSH)</term><term>Electrocardiography (drug effects)</term><term>Humans (MeSH)</term><term>Long QT Syndrome (chemically induced)</term><term>Long QT Syndrome (epidemiology)</term><term>Pharmacovigilance (MeSH)</term><term>Torsades de Pointes (chemically induced)</term><term>Torsades de Pointes (epidemiology)</term><term>United States (MeSH)</term><term>United States Food and Drug Administration (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Antimalarials</term><term>Azithromycin</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Anti-Bacterial Agents</term><term>Antimalarials</term><term>Azithromycin</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Arrhythmias, Cardiac</term><term>Long QT Syndrome</term><term>Torsades de Pointes</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Electrocardiography</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Long QT Syndrome</term><term>Torsades de Pointes</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adverse Drug Reaction Reporting Systems</term><term>Drug Therapy, Combination</term><term>Humans</term><term>Pharmacovigilance</term><term>United States Food and Drug Administration</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><b>Background</b>: Hydroxychloroquine, an antimalarial drug, combined with azithromycin has been considered a potential treatment for COVID-19. However, these drugs may cause electrocardiogram QT prolongation (QTp) and torsade de Pointes (TdP). We examined potential safety signals for these cardiac arrhythmias. <b>Methods</b>: Using the OpenVigil 2.1 MedDRA platform, we mined data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) from December 2019 to June 2020. We extracted individual case safety reports based on exposures of seven antimalarial drugs, azithromycin, and combinations. All other drugs in FAERS served as controls. Events of interest included QTp and TdP, with associations between drug exposures and events expressed as adjusted Reporting-Odds-Ratios (aRORs) and confidence intervals. The lower end of aROR 95% confidence interval >1 was used as the statistically significant signal detection threshold. <b>Results</b>: QTp safety signals were found for hydroxychloroquine[aROR:11.70 (10.40-13.16)], chloroquine[aROR:18.97 (11.30-31.87)], quinine[aROR:16.66 (10.18-27.25)], atovaquone[aROR:6.91 (4.14-11.56)], azithromycin alone [aROR:28.02 (22.87-34.32)] and hydroxychloroquine + azithromycin [aROR:75.23 (51.15-110.66)]. TdP safety signals were found for hydroxychloroquine [aROR: 5.62 (4.94-6.38)], chloroquine[aROR:49.37 (30.63-79.58)], and hydroxychloroquine + azithromycin[aROR:33.09 (21.22-51.61)]. <b>Conclusion</b>: Hydroxychloroquine/chloroquine and/or azithromycin was associated with QTp/TdP safety signals and their use should be monitored carefully.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33186061</PMID><DateCompleted><Year>2021</Year><Month>02</Month><Day>04</Day></DateCompleted><DateRevised><Year>2021</Year><Month>05</Month><Day>07</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1744-8379</ISSN><JournalIssue CitedMedium="Internet"><Volume>21</Volume><Issue>1</Issue><PubDate><Year>2021</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Expert review of pharmacoeconomics & outcomes research</Title><ISOAbbreviation>Expert Rev Pharmacoecon Outcomes Res</ISOAbbreviation></Journal><ArticleTitle>A pharmacovigilance study to quantify the strength of association between the combination of antimalarial drugs and azithromycin and cardiac arrhythmias: implications for the treatment of COVID-19.</ArticleTitle><Pagination><MedlinePgn>159-168</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1080/14737167.2021.1851600</ELocationID><Abstract><AbstractText><b>Background</b>: Hydroxychloroquine, an antimalarial drug, combined with azithromycin has been considered a potential treatment for COVID-19. However, these drugs may cause electrocardiogram QT prolongation (QTp) and torsade de Pointes (TdP). We examined potential safety signals for these cardiac arrhythmias. <b>Methods</b>: Using the OpenVigil 2.1 MedDRA platform, we mined data from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) from December 2019 to June 2020. We extracted individual case safety reports based on exposures of seven antimalarial drugs, azithromycin, and combinations. All other drugs in FAERS served as controls. Events of interest included QTp and TdP, with associations between drug exposures and events expressed as adjusted Reporting-Odds-Ratios (aRORs) and confidence intervals. The lower end of aROR 95% confidence interval >1 was used as the statistically significant signal detection threshold. <b>Results</b>: QTp safety signals were found for hydroxychloroquine[aROR:11.70 (10.40-13.16)], chloroquine[aROR:18.97 (11.30-31.87)], quinine[aROR:16.66 (10.18-27.25)], atovaquone[aROR:6.91 (4.14-11.56)], azithromycin alone [aROR:28.02 (22.87-34.32)] and hydroxychloroquine + azithromycin [aROR:75.23 (51.15-110.66)]. TdP safety signals were found for hydroxychloroquine [aROR: 5.62 (4.94-6.38)], chloroquine[aROR:49.37 (30.63-79.58)], and hydroxychloroquine + azithromycin[aROR:33.09 (21.22-51.61)]. <b>Conclusion</b>: Hydroxychloroquine/chloroquine and/or azithromycin was associated with QTp/TdP safety signals and their use should be monitored carefully.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Diaby</LastName><ForeName>Vakaramoko</ForeName><Initials>V</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-6251-0773</Identifier><AffiliationInfo><Affiliation>College of Pharmacy, HPNP 3317, University of Florida , Gainesville, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Almutairi</LastName><ForeName>Reem D</ForeName><Initials>RD</Initials><Identifier Source="ORCID">https://orcid.org/0000-0002-4391-5345</Identifier><AffiliationInfo><Affiliation>Department of Pharmaceutical Business and Administration Sciences, MCPHS University , Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Ziyan</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>College of Pharmacy, HPNP 3317, University of Florida , Gainesville, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Moussa</LastName><ForeName>Richard K</ForeName><Initials>RK</Initials><Identifier Source="ORCID">https://orcid.org/0000-0003-0046-1053</Identifier><AffiliationInfo><Affiliation>Théorie Économique, Modélisation et Applications (ThEMA), Université de Cergy-Pontoise, France and Ecole Nationale Supérieure de Statistiques et d'Economie Appliquée (ENSEA).</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Berthe</LastName><ForeName>Abdrahmane</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Northwest Territories Government , Yellowknife, Canada.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>12</Month><Day>08</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Expert Rev Pharmacoecon Outcomes Res</MedlineTA><NlmUniqueID>101132257</NlmUniqueID><ISSNLinking>1473-7167</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000900">Anti-Bacterial Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000962">Antimalarials</NameOfSubstance></Chemical><Chemical><RegistryNumber>83905-01-5</RegistryNumber><NameOfSubstance UI="D017963">Azithromycin</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D016907" MajorTopicYN="N">Adverse Drug Reaction Reporting Systems</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000900" MajorTopicYN="N">Anti-Bacterial Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000962" MajorTopicYN="N">Antimalarials</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001145" MajorTopicYN="N">Arrhythmias, Cardiac</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017963" MajorTopicYN="N">Azithromycin</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004562" MajorTopicYN="N">Electrocardiography</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008133" MajorTopicYN="N">Long QT Syndrome</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D060735" MajorTopicYN="Y">Pharmacovigilance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016171" MajorTopicYN="N">Torsades de Pointes</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014486" MajorTopicYN="N">United States Food and Drug Administration</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Antimalarial drugs</Keyword><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">azithromycin</Keyword><Keyword MajorTopicYN="N">electrocardiogram QT prolonged</Keyword><Keyword MajorTopicYN="N">hydroxychloroquine</Keyword><Keyword MajorTopicYN="N">torsade de 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