RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.
Identifieur interne : 001595 ( Main/Corpus ); précédent : 001594; suivant : 001596RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.
Auteurs : Mandeep R. Mehra ; Sapan S. Desai ; Frank Ruschitzka ; Amit N. PatelSource :
- Lancet (London, England) [ 1474-547X ] ; 2020.
Abstract
BACKGROUND
Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit. Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19.
METHODS
We did a multinational registry analysis of the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19. The registry comprised data from 671 hospitals in six continents. We included patients hospitalised between Dec 20, 2019, and April 14, 2020, with a positive laboratory finding for SARS-CoV-2. Patients who received one of the treatments of interest within 48 h of diagnosis were included in one of four treatment groups (chloroquine alone, chloroquine with a macrolide, hydroxychloroquine alone, or hydroxychloroquine with a macrolide), and patients who received none of these treatments formed the control group. Patients for whom one of the treatments of interest was initiated more than 48 h after diagnosis or while they were on mechanical ventilation, as well as patients who received remdesivir, were excluded. The main outcomes of interest were in-hospital mortality and the occurrence of de-novo ventricular arrhythmias (non-sustained or sustained ventricular tachycardia or ventricular fibrillation).
FINDINGS
96 032 patients (mean age 53·8 years, 46·3% women) with COVID-19 were hospitalised during the study period and met the inclusion criteria. Of these, 14 888 patients were in the treatment groups (1868 received chloroquine, 3783 received chloroquine with a macrolide, 3016 received hydroxychloroquine, and 6221 received hydroxychloroquine with a macrolide) and 81 144 patients were in the control group. 10 698 (11·1%) patients died in hospital. After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223-1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368-1·531), chloroquine (16·4%; 1·365, 1·218-1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273-1·469) were each independently associated with an increased risk of in-hospital mortality. Compared with the control group (0·3%), hydroxychloroquine (6·1%; 2·369, 1·935-2·900), hydroxychloroquine with a macrolide (8·1%; 5·106, 4·106-5·983), chloroquine (4·3%; 3·561, 2·760-4·596), and chloroquine with a macrolide (6·5%; 4·011, 3·344-4·812) were independently associated with an increased risk of de-novo ventricular arrhythmia during hospitalisation.
INTERPRETATION
We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.
FUNDING
William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women's Hospital.
DOI: 10.1016/S0140-6736(20)31180-6
PubMed: 32450107
PubMed Central: PMC7255293
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.</title><author><name sortKey="Mehra, Mandeep R" sort="Mehra, Mandeep R" uniqKey="Mehra M" first="Mandeep R" last="Mehra">Mandeep R. Mehra</name><affiliation><nlm:affiliation>Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA. Electronic address: mmehra@bwh.harvard.edu.</nlm:affiliation></affiliation></author><author><name sortKey="Desai, Sapan S" sort="Desai, Sapan S" uniqKey="Desai S" first="Sapan S" last="Desai">Sapan S. Desai</name><affiliation><nlm:affiliation>Surgisphere Corporation, Chicago, IL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ruschitzka, Frank" sort="Ruschitzka, Frank" uniqKey="Ruschitzka F" first="Frank" last="Ruschitzka">Frank Ruschitzka</name><affiliation><nlm:affiliation>University Heart Center, University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Patel, Amit N" sort="Patel, Amit N" uniqKey="Patel A" first="Amit N" last="Patel">Amit N. Patel</name><affiliation><nlm:affiliation>Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA; HCA Research Institute, Nashville, TN, USA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32450107</idno><idno type="pmid">32450107</idno><idno type="doi">10.1016/S0140-6736(20)31180-6</idno><idno type="pmc">PMC7255293</idno><idno type="wicri:Area/Main/Corpus">001595</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001595</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.</title><author><name sortKey="Mehra, Mandeep R" sort="Mehra, Mandeep R" uniqKey="Mehra M" first="Mandeep R" last="Mehra">Mandeep R. Mehra</name><affiliation><nlm:affiliation>Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA. Electronic address: mmehra@bwh.harvard.edu.</nlm:affiliation></affiliation></author><author><name sortKey="Desai, Sapan S" sort="Desai, Sapan S" uniqKey="Desai S" first="Sapan S" last="Desai">Sapan S. Desai</name><affiliation><nlm:affiliation>Surgisphere Corporation, Chicago, IL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Ruschitzka, Frank" sort="Ruschitzka, Frank" uniqKey="Ruschitzka F" first="Frank" last="Ruschitzka">Frank Ruschitzka</name><affiliation><nlm:affiliation>University Heart Center, University Hospital Zurich, Zurich, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Patel, Amit N" sort="Patel, Amit N" uniqKey="Patel A" first="Amit N" last="Patel">Amit N. Patel</name><affiliation><nlm:affiliation>Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA; HCA Research Institute, Nashville, TN, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Lancet (London, England)</title><idno type="eISSN">1474-547X</idno><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>Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit. Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We did a multinational registry analysis of the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19. The registry comprised data from 671 hospitals in six continents. We included patients hospitalised between Dec 20, 2019, and April 14, 2020, with a positive laboratory finding for SARS-CoV-2. Patients who received one of the treatments of interest within 48 h of diagnosis were included in one of four treatment groups (chloroquine alone, chloroquine with a macrolide, hydroxychloroquine alone, or hydroxychloroquine with a macrolide), and patients who received none of these treatments formed the control group. Patients for whom one of the treatments of interest was initiated more than 48 h after diagnosis or while they were on mechanical ventilation, as well as patients who received remdesivir, were excluded. The main outcomes of interest were in-hospital mortality and the occurrence of de-novo ventricular arrhythmias (non-sustained or sustained ventricular tachycardia or ventricular fibrillation).</p></div><div type="abstract" xml:lang="en"><p><b>FINDINGS</b></p><p>96 032 patients (mean age 53·8 years, 46·3% women) with COVID-19 were hospitalised during the study period and met the inclusion criteria. Of these, 14 888 patients were in the treatment groups (1868 received chloroquine, 3783 received chloroquine with a macrolide, 3016 received hydroxychloroquine, and 6221 received hydroxychloroquine with a macrolide) and 81 144 patients were in the control group. 10 698 (11·1%) patients died in hospital. After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223-1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368-1·531), chloroquine (16·4%; 1·365, 1·218-1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273-1·469) were each independently associated with an increased risk of in-hospital mortality. Compared with the control group (0·3%), hydroxychloroquine (6·1%; 2·369, 1·935-2·900), hydroxychloroquine with a macrolide (8·1%; 5·106, 4·106-5·983), chloroquine (4·3%; 3·561, 2·760-4·596), and chloroquine with a macrolide (6·5%; 4·011, 3·344-4·812) were independently associated with an increased risk of de-novo ventricular arrhythmia during hospitalisation.</p></div><div type="abstract" xml:lang="en"><p><b>INTERPRETATION</b></p><p>We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>FUNDING</b></p><p>William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women's Hospital.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">32450107</PMID><DateRevised><Year>2020</Year><Month>12</Month><Day>22</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-547X</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>05</Month><Day>22</Day></PubDate></JournalIssue><Title>Lancet (London, England)</Title><ISOAbbreviation>Lancet</ISOAbbreviation></Journal><ArticleTitle>RETRACTED: Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">S0140-6736(20)31180-6</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S0140-6736(20)31180-6</ELocationID><Abstract><AbstractText Label="BACKGROUND">Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit. Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19.</AbstractText><AbstractText Label="METHODS">We did a multinational registry analysis of the use of hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19. The registry comprised data from 671 hospitals in six continents. We included patients hospitalised between Dec 20, 2019, and April 14, 2020, with a positive laboratory finding for SARS-CoV-2. Patients who received one of the treatments of interest within 48 h of diagnosis were included in one of four treatment groups (chloroquine alone, chloroquine with a macrolide, hydroxychloroquine alone, or hydroxychloroquine with a macrolide), and patients who received none of these treatments formed the control group. Patients for whom one of the treatments of interest was initiated more than 48 h after diagnosis or while they were on mechanical ventilation, as well as patients who received remdesivir, were excluded. The main outcomes of interest were in-hospital mortality and the occurrence of de-novo ventricular arrhythmias (non-sustained or sustained ventricular tachycardia or ventricular fibrillation).</AbstractText><AbstractText Label="FINDINGS">96 032 patients (mean age 53·8 years, 46·3% women) with COVID-19 were hospitalised during the study period and met the inclusion criteria. Of these, 14 888 patients were in the treatment groups (1868 received chloroquine, 3783 received chloroquine with a macrolide, 3016 received hydroxychloroquine, and 6221 received hydroxychloroquine with a macrolide) and 81 144 patients were in the control group. 10 698 (11·1%) patients died in hospital. After controlling for multiple confounding factors (age, sex, race or ethnicity, body-mass index, underlying cardiovascular disease and its risk factors, diabetes, underlying lung disease, smoking, immunosuppressed condition, and baseline disease severity), when compared with mortality in the control group (9·3%), hydroxychloroquine (18·0%; hazard ratio 1·335, 95% CI 1·223-1·457), hydroxychloroquine with a macrolide (23·8%; 1·447, 1·368-1·531), chloroquine (16·4%; 1·365, 1·218-1·531), and chloroquine with a macrolide (22·2%; 1·368, 1·273-1·469) were each independently associated with an increased risk of in-hospital mortality. Compared with the control group (0·3%), hydroxychloroquine (6·1%; 2·369, 1·935-2·900), hydroxychloroquine with a macrolide (8·1%; 5·106, 4·106-5·983), chloroquine (4·3%; 3·561, 2·760-4·596), and chloroquine with a macrolide (6·5%; 4·011, 3·344-4·812) were independently associated with an increased risk of de-novo ventricular arrhythmia during hospitalisation.</AbstractText><AbstractText Label="INTERPRETATION">We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.</AbstractText><AbstractText Label="FUNDING">William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women's Hospital.</AbstractText><CopyrightInformation>Copyright © 2020 Elsevier Ltd. 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