Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19.
Identifieur interne : 001463 ( Main/Corpus ); précédent : 001462; suivant : 001464Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19.
Auteurs : Joseph Magagnoli ; Siddharth Narendran ; Felipe Pereira ; Tammy Cummings ; James W. Hardin ; S Scott Sutton ; Jayakrishna AmbatiSource :
- medRxiv : the preprint server for health sciences ; 2020.
Abstract
BACKGROUND
Despite limited and conflicting data on the use of hydroxychloroquine in patients with Covid-19, the U.S. Food and Drug Administration has authorized the emergency use of this drug when clinical trials are unavailable or infeasible. Hydroxychloroquine, alone or in combination with azithromycin, is being widely used in Covid-19 therapy based on anecdotal and limited observational evidence.
METHODS
We performed a retrospective analysis of data from patients hospitalized with confirmed SARS-CoV-2 infection in all United States Veterans Health Administration medical centers until April 11, 2020. Patients were categorized based on their exposure to hydroxychloroquine alone (HC) or with azithromycin (HC+AZ) as treatments in addition to standard supportive management for Covid-19. The two primary outcomes were death and the need for mechanical ventilation. We determined the association between treatment and the primary outcomes using competing risk hazard regression adjusting for clinical characteristics via propensity scores. Discharge and death were taken into account as competing risks and subdistribution hazard ratios are presented.
RESULTS
A total of 368 patients were evaluated (HC, n=97; HC+AZ, n=113; no HC, n=158). Rates of death in the HC, HC+AZ, and no HC groups were 27.8%, 22.1%, 11.4%, respectively. Rates of ventilation in the HC, HC+AZ, and no HC groups were 13.3%, 6.9%, 14.1%, respectively. Compared to the no HC group, the risk of death from any cause was higher in the HC group (adjusted hazard ratio, 2.61; 95% CI, 1.10 to 6.17; P=0.03) but not in the HC+AZ group (adjusted hazard ratio, 1.14; 95% CI, 0.56 to 2.32; P=0.72). The risk of ventilation was similar in the HC group (adjusted hazard ratio, 1.43; 95% CI, 0.53 to 3.79; P=0.48) and in the HC+AZ group (adjusted hazard ratio, 0.43; 95% CI, 0.16 to 1.12; P=0.09), compared to the no HC group.
CONCLUSIONS
In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19. An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone. These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.
DOI: 10.1101/2020.04.16.20065920
PubMed: 32511622
PubMed Central: PMC7276049
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pubmed:32511622Le document en format XML
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Hardin</name><affiliation><nlm:affiliation>Department of Epidemiology & Biostatistics, University of South Carolina, Columbia, South Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sutton, S Scott" sort="Sutton, S Scott" uniqKey="Sutton S" first="S Scott" last="Sutton">S Scott Sutton</name><affiliation><nlm:affiliation>Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Clinical Pharmacy & Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ambati, Jayakrishna" sort="Ambati, Jayakrishna" uniqKey="Ambati J" first="Jayakrishna" last="Ambati">Jayakrishna Ambati</name><affiliation><nlm:affiliation>Center for Advanced Vision Science, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Microbiology, Immunology, and Cancer Biology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32511622</idno><idno type="pmid">32511622</idno><idno type="doi">10.1101/2020.04.16.20065920</idno><idno type="pmc">PMC7276049</idno><idno type="wicri:Area/Main/Corpus">001463</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001463</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19.</title><author><name sortKey="Magagnoli, Joseph" sort="Magagnoli, Joseph" uniqKey="Magagnoli J" first="Joseph" last="Magagnoli">Joseph Magagnoli</name><affiliation><nlm:affiliation>Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Clinical Pharmacy & Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Narendran, Siddharth" sort="Narendran, Siddharth" uniqKey="Narendran S" first="Siddharth" last="Narendran">Siddharth Narendran</name><affiliation><nlm:affiliation>Center for Advanced Vision Science, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Pereira, Felipe" sort="Pereira, Felipe" uniqKey="Pereira F" first="Felipe" last="Pereira">Felipe Pereira</name><affiliation><nlm:affiliation>Center for Advanced Vision Science, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Cummings, Tammy" sort="Cummings, Tammy" uniqKey="Cummings T" first="Tammy" last="Cummings">Tammy Cummings</name><affiliation><nlm:affiliation>Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Hardin, James W" sort="Hardin, James W" uniqKey="Hardin J" first="James W" last="Hardin">James W. Hardin</name><affiliation><nlm:affiliation>Department of Epidemiology & Biostatistics, University of South Carolina, Columbia, South Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sutton, S Scott" sort="Sutton, S Scott" uniqKey="Sutton S" first="S Scott" last="Sutton">S Scott Sutton</name><affiliation><nlm:affiliation>Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Clinical Pharmacy & Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ambati, Jayakrishna" sort="Ambati, Jayakrishna" uniqKey="Ambati J" first="Jayakrishna" last="Ambati">Jayakrishna Ambati</name><affiliation><nlm:affiliation>Center for Advanced Vision Science, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Microbiology, Immunology, and Cancer Biology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">medRxiv : the preprint server for health sciences</title><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Despite limited and conflicting data on the use of hydroxychloroquine in patients with Covid-19, the U.S. Food and Drug Administration has authorized the emergency use of this drug when clinical trials are unavailable or infeasible. Hydroxychloroquine, alone or in combination with azithromycin, is being widely used in Covid-19 therapy based on anecdotal and limited observational evidence.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We performed a retrospective analysis of data from patients hospitalized with confirmed SARS-CoV-2 infection in all United States Veterans Health Administration medical centers until April 11, 2020. Patients were categorized based on their exposure to hydroxychloroquine alone (HC) or with azithromycin (HC+AZ) as treatments in addition to standard supportive management for Covid-19. The two primary outcomes were death and the need for mechanical ventilation. We determined the association between treatment and the primary outcomes using competing risk hazard regression adjusting for clinical characteristics via propensity scores. Discharge and death were taken into account as competing risks and subdistribution hazard ratios are presented.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>A total of 368 patients were evaluated (HC, n=97; HC+AZ, n=113; no HC, n=158). Rates of death in the HC, HC+AZ, and no HC groups were 27.8%, 22.1%, 11.4%, respectively. Rates of ventilation in the HC, HC+AZ, and no HC groups were 13.3%, 6.9%, 14.1%, respectively. Compared to the no HC group, the risk of death from any cause was higher in the HC group (adjusted hazard ratio, 2.61; 95% CI, 1.10 to 6.17; P=0.03) but not in the HC+AZ group (adjusted hazard ratio, 1.14; 95% CI, 0.56 to 2.32; P=0.72). The risk of ventilation was similar in the HC group (adjusted hazard ratio, 1.43; 95% CI, 0.53 to 3.79; P=0.48) and in the HC+AZ group (adjusted hazard ratio, 0.43; 95% CI, 0.16 to 1.12; P=0.09), compared to the no HC group.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19. An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone. These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">32511622</PMID><DateRevised><Year>2021</Year><Month>01</Month><Day>10</Day></DateRevised><Article PubModel="Electronic"><Journal><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Apr</Month><Day>21</Day></PubDate></JournalIssue><Title>medRxiv : the preprint server for health sciences</Title><ISOAbbreviation>medRxiv</ISOAbbreviation></Journal><ArticleTitle>Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">2020.04.16.20065920</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1101/2020.04.16.20065920</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Despite limited and conflicting data on the use of hydroxychloroquine in patients with Covid-19, the U.S. Food and Drug Administration has authorized the emergency use of this drug when clinical trials are unavailable or infeasible. Hydroxychloroquine, alone or in combination with azithromycin, is being widely used in Covid-19 therapy based on anecdotal and limited observational evidence.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We performed a retrospective analysis of data from patients hospitalized with confirmed SARS-CoV-2 infection in all United States Veterans Health Administration medical centers until April 11, 2020. Patients were categorized based on their exposure to hydroxychloroquine alone (HC) or with azithromycin (HC+AZ) as treatments in addition to standard supportive management for Covid-19. The two primary outcomes were death and the need for mechanical ventilation. We determined the association between treatment and the primary outcomes using competing risk hazard regression adjusting for clinical characteristics via propensity scores. Discharge and death were taken into account as competing risks and subdistribution hazard ratios are presented.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">A total of 368 patients were evaluated (HC, n=97; HC+AZ, n=113; no HC, n=158). Rates of death in the HC, HC+AZ, and no HC groups were 27.8%, 22.1%, 11.4%, respectively. Rates of ventilation in the HC, HC+AZ, and no HC groups were 13.3%, 6.9%, 14.1%, respectively. Compared to the no HC group, the risk of death from any cause was higher in the HC group (adjusted hazard ratio, 2.61; 95% CI, 1.10 to 6.17; P=0.03) but not in the HC+AZ group (adjusted hazard ratio, 1.14; 95% CI, 0.56 to 2.32; P=0.72). The risk of ventilation was similar in the HC group (adjusted hazard ratio, 1.43; 95% CI, 0.53 to 3.79; P=0.48) and in the HC+AZ group (adjusted hazard ratio, 0.43; 95% CI, 0.16 to 1.12; P=0.09), compared to the no HC group.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19. An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone. These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Magagnoli</LastName><ForeName>Joseph</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Clinical Pharmacy & Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Narendran</LastName><ForeName>Siddharth</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Center for Advanced Vision Science, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pereira</LastName><ForeName>Felipe</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Center for Advanced Vision Science, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cummings</LastName><ForeName>Tammy</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hardin</LastName><ForeName>James W</ForeName><Initials>JW</Initials><AffiliationInfo><Affiliation>Department of Epidemiology & Biostatistics, University of South Carolina, Columbia, South Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sutton</LastName><ForeName>S Scott</ForeName><Initials>SS</Initials><AffiliationInfo><Affiliation>Dorn Research Institute, Columbia VA Health Care System, Columbia, South Carolina, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Clinical Pharmacy & Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ambati</LastName><ForeName>Jayakrishna</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Center for Advanced Vision Science, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Pathology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Microbiology, Immunology, and Cancer Biology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D000076942">Preprint</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>04</Month><Day>21</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>medRxiv</MedlineTA><NlmUniqueID>101767986</NlmUniqueID></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="UpdateIn"><RefSource>Med (N Y). 2020 Jun 5;:</RefSource><PMID 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