The Cardiovascular Effects of Treatment with Hydroxychloroquine and Azithromycin.
Identifieur interne : 001117 ( Main/Corpus ); précédent : 001116; suivant : 001118The Cardiovascular Effects of Treatment with Hydroxychloroquine and Azithromycin.
Auteurs : Jacob E. Simmering ; Linnea A. Polgreen ; Philip M. Polgreen ; Rebecca E. Teske ; Alejandro P. Comellas ; Barry L. CarterSource :
- Pharmacotherapy [ 1875-9114 ] ; 2020.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Age Factors (MeSH), Aged (MeSH), Aged, 80 and over (MeSH), Azithromycin (administration & dosage), Azithromycin (adverse effects), COVID-19 (drug therapy), Cardiotoxicity (epidemiology), Cardiotoxicity (etiology), Cardiovascular Diseases (chemically induced), Cardiovascular Diseases (epidemiology), Child (MeSH), Child, Preschool (MeSH), Databases, Factual (MeSH), Drug Therapy, Combination (MeSH), Female (MeSH), Humans (MeSH), Hydroxychloroquine (administration & dosage), Hydroxychloroquine (adverse effects), Infant (MeSH), Infant, Newborn (MeSH), Male (MeSH), Middle Aged (MeSH), Risk Factors (MeSH), Sex Factors (MeSH), Young Adult (MeSH).
- MESH :
- chemical , administration & dosage : Azithromycin, Hydroxychloroquine.
- chemical , adverse effects : Azithromycin, Hydroxychloroquine.
- chemically induced : Cardiovascular Diseases.
- drug therapy : COVID-19.
- epidemiology : Cardiotoxicity, Cardiovascular Diseases.
- etiology : Cardiotoxicity.
- Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Child, Child, Preschool, Databases, Factual, Drug Therapy, Combination, Female, Humans, Infant, Infant, Newborn, Male, Middle Aged, Risk Factors, Sex Factors, Young Adult.
Abstract
Hydroxychloroquine combined with azithromycin has been investigated for activity against coronavirus disease 2019 (COVID-19), but concerns about adverse cardiovascular (CV) effects have been raised. This study evaluated claims data to determine if risks for CV events were increased with hydroxychloroquine alone or combined with azithromycin. We identified data from 43,752 enrollees that qualified for analysis. The number of CV events increased by 25 (95% confidence interval [CI]: 8, 42, p=0.005) per 1000 people per year of treatment with hydroxychloroquine alone compared with pretreatment levels and by 201 (95% CI: 145, 256, p<0.001) events per 1000 people per year when individuals took hydroxychloroquine and azithromycin. These rates translate to an additional 0.34 (95% CI: 0.11, 0.58) CV events per 1000 patients placed on a 5-day treatment with hydroxychloroquine monotherapy and 2.75 (95% CI: 1.99, 3.51) per 1000 patients on a 5-day treatment with both hydroxychloroquine and azithromycin. The rate of adverse events increased with age following exposure to hydroxychloroquine alone and combined with azithromycin. For females aged 60 to 79 years prescribed hydroxychloroquine, the rate of adverse CV events was 0.92 per 1000 patients on 5 days of therapy, but it increased to 4.78 per 1000 patients when azithromycin was added. The rate of adverse CV events did not differ significantly from zero for patients 60 years of age or younger. These data suggest that hydroxychloroquine with or without azithromycin is likely safe in individuals under 60 years of age if they do not have additional CV risks. However, the combination of hydroxychloroquine and azithromycin should be used with extreme caution in older patients.
DOI: 10.1002/phar.2445
PubMed: 32677113
PubMed Central: PMC7404845
Links to Exploration step
pubmed:32677113Le document en format XML
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Polgreen</name><affiliation><nlm:affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Teske, Rebecca E" sort="Teske, Rebecca E" uniqKey="Teske R" first="Rebecca E" last="Teske">Rebecca E. Teske</name><affiliation><nlm:affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Comellas, Alejandro P" sort="Comellas, Alejandro P" uniqKey="Comellas A" first="Alejandro P" last="Comellas">Alejandro P. 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Simmering</name><affiliation><nlm:affiliation>Health Ventures Signal Center for Healthcare Innovation, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Polgreen, Linnea A" sort="Polgreen, Linnea A" uniqKey="Polgreen L" first="Linnea A" last="Polgreen">Linnea A. Polgreen</name><affiliation><nlm:affiliation>Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Polgreen, Philip M" sort="Polgreen, Philip M" uniqKey="Polgreen P" first="Philip M" last="Polgreen">Philip M. Polgreen</name><affiliation><nlm:affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Teske, Rebecca E" sort="Teske, Rebecca E" uniqKey="Teske R" first="Rebecca E" last="Teske">Rebecca E. Teske</name><affiliation><nlm:affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Comellas, Alejandro P" sort="Comellas, Alejandro P" uniqKey="Comellas A" first="Alejandro P" last="Comellas">Alejandro P. Comellas</name><affiliation><nlm:affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Carter, Barry L" sort="Carter, Barry L" uniqKey="Carter B" first="Barry L" last="Carter">Barry L. Carter</name><affiliation><nlm:affiliation>Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Family Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Pharmacotherapy</title><idno type="eISSN">1875-9114</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent (MeSH)</term><term>Adult (MeSH)</term><term>Age Factors (MeSH)</term><term>Aged (MeSH)</term><term>Aged, 80 and over (MeSH)</term><term>Azithromycin (administration & dosage)</term><term>Azithromycin (adverse effects)</term><term>COVID-19 (drug therapy)</term><term>Cardiotoxicity (epidemiology)</term><term>Cardiotoxicity (etiology)</term><term>Cardiovascular Diseases (chemically induced)</term><term>Cardiovascular Diseases (epidemiology)</term><term>Child (MeSH)</term><term>Child, Preschool (MeSH)</term><term>Databases, Factual (MeSH)</term><term>Drug Therapy, Combination (MeSH)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (administration & dosage)</term><term>Hydroxychloroquine (adverse effects)</term><term>Infant (MeSH)</term><term>Infant, Newborn (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Risk Factors (MeSH)</term><term>Sex Factors (MeSH)</term><term>Young Adult (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Azithromycin</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Azithromycin</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Cardiovascular Diseases</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>Cardiotoxicity</term><term>Cardiovascular Diseases</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Cardiotoxicity</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Age Factors</term><term>Aged</term><term>Aged, 80 and over</term><term>Child</term><term>Child, Preschool</term><term>Databases, Factual</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Infant</term><term>Infant, Newborn</term><term>Male</term><term>Middle Aged</term><term>Risk Factors</term><term>Sex Factors</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Hydroxychloroquine combined with azithromycin has been investigated for activity against coronavirus disease 2019 (COVID-19), but concerns about adverse cardiovascular (CV) effects have been raised. This study evaluated claims data to determine if risks for CV events were increased with hydroxychloroquine alone or combined with azithromycin. We identified data from 43,752 enrollees that qualified for analysis. The number of CV events increased by 25 (95% confidence interval [CI]: 8, 42, p=0.005) per 1000 people per year of treatment with hydroxychloroquine alone compared with pretreatment levels and by 201 (95% CI: 145, 256, p<0.001) events per 1000 people per year when individuals took hydroxychloroquine and azithromycin. These rates translate to an additional 0.34 (95% CI: 0.11, 0.58) CV events per 1000 patients placed on a 5-day treatment with hydroxychloroquine monotherapy and 2.75 (95% CI: 1.99, 3.51) per 1000 patients on a 5-day treatment with both hydroxychloroquine and azithromycin. The rate of adverse events increased with age following exposure to hydroxychloroquine alone and combined with azithromycin. For females aged 60 to 79 years prescribed hydroxychloroquine, the rate of adverse CV events was 0.92 per 1000 patients on 5 days of therapy, but it increased to 4.78 per 1000 patients when azithromycin was added. The rate of adverse CV events did not differ significantly from zero for patients 60 years of age or younger. These data suggest that hydroxychloroquine with or without azithromycin is likely safe in individuals under 60 years of age if they do not have additional CV risks. However, the combination of hydroxychloroquine and azithromycin should be used with extreme caution in older patients.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32677113</PMID><DateCompleted><Year>2020</Year><Month>12</Month><Day>14</Day></DateCompleted><DateRevised><Year>2021</Year><Month>01</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1875-9114</ISSN><JournalIssue CitedMedium="Internet"><Volume>40</Volume><Issue>9</Issue><PubDate><Year>2020</Year><Month>09</Month></PubDate></JournalIssue><Title>Pharmacotherapy</Title><ISOAbbreviation>Pharmacotherapy</ISOAbbreviation></Journal><ArticleTitle>The Cardiovascular Effects of Treatment with Hydroxychloroquine and Azithromycin.</ArticleTitle><Pagination><MedlinePgn>978-983</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/phar.2445</ELocationID><Abstract><AbstractText>Hydroxychloroquine combined with azithromycin has been investigated for activity against coronavirus disease 2019 (COVID-19), but concerns about adverse cardiovascular (CV) effects have been raised. This study evaluated claims data to determine if risks for CV events were increased with hydroxychloroquine alone or combined with azithromycin. We identified data from 43,752 enrollees that qualified for analysis. The number of CV events increased by 25 (95% confidence interval [CI]: 8, 42, p=0.005) per 1000 people per year of treatment with hydroxychloroquine alone compared with pretreatment levels and by 201 (95% CI: 145, 256, p<0.001) events per 1000 people per year when individuals took hydroxychloroquine and azithromycin. These rates translate to an additional 0.34 (95% CI: 0.11, 0.58) CV events per 1000 patients placed on a 5-day treatment with hydroxychloroquine monotherapy and 2.75 (95% CI: 1.99, 3.51) per 1000 patients on a 5-day treatment with both hydroxychloroquine and azithromycin. The rate of adverse events increased with age following exposure to hydroxychloroquine alone and combined with azithromycin. For females aged 60 to 79 years prescribed hydroxychloroquine, the rate of adverse CV events was 0.92 per 1000 patients on 5 days of therapy, but it increased to 4.78 per 1000 patients when azithromycin was added. The rate of adverse CV events did not differ significantly from zero for patients 60 years of age or younger. These data suggest that hydroxychloroquine with or without azithromycin is likely safe in individuals under 60 years of age if they do not have additional CV risks. However, the combination of hydroxychloroquine and azithromycin should be used with extreme caution in older patients.</AbstractText><CopyrightInformation>© 2020 Pharmacotherapy Publications, Inc.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Simmering</LastName><ForeName>Jacob E</ForeName><Initials>JE</Initials><AffiliationInfo><Affiliation>Health Ventures Signal Center for Healthcare Innovation, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Polgreen</LastName><ForeName>Linnea A</ForeName><Initials>LA</Initials><AffiliationInfo><Affiliation>Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Polgreen</LastName><ForeName>Philip M</ForeName><Initials>PM</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Teske</LastName><ForeName>Rebecca E</ForeName><Initials>RE</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Comellas</LastName><ForeName>Alejandro P</ForeName><Initials>AP</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carter</LastName><ForeName>Barry L</ForeName><Initials>BL</Initials><Identifier Source="ORCID">0000-0002-0466-343X</Identifier><AffiliationInfo><Affiliation>Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Family Medicine, College of Medicine, University of Iowa, Iowa City, Iowa, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>P30 ES005605</GrantID><Acronym>ES</Acronym><Agency>NIEHS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>UL1 TR002537</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D052061">Research Support, N.I.H., Extramural</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>08</Month><Day>04</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Pharmacotherapy</MedlineTA><NlmUniqueID>8111305</NlmUniqueID><ISSNLinking>0277-0008</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical><Chemical><RegistryNumber>83905-01-5</RegistryNumber><NameOfSubstance UI="D017963">Azithromycin</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000367" MajorTopicYN="N">Age Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017963" MajorTopicYN="N">Azithromycin</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D066126" MajorTopicYN="N">Cardiotoxicity</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName><QualifierName UI="Q000209" MajorTopicYN="Y">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002318" MajorTopicYN="N">Cardiovascular Diseases</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016208" MajorTopicYN="N">Databases, Factual</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007223" MajorTopicYN="N">Infant</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007231" MajorTopicYN="N">Infant, Newborn</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012737" MajorTopicYN="N">Sex Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">azithromycin</Keyword><Keyword MajorTopicYN="Y">coronavirus infections</Keyword><Keyword 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