Safety and efficacy of hydroxychloroquine in 152 outpatients with confirmed COVID-19: A pilot observational study.
Identifieur interne : 000625 ( Main/Corpus ); précédent : 000624; suivant : 000626Safety and efficacy of hydroxychloroquine in 152 outpatients with confirmed COVID-19: A pilot observational study.
Auteurs : Ozgur Sogut ; Mehmet Mustafa Can ; Ramazan Guven ; Onur Kaplan ; Hüseyin Ergenc ; Tuba Betül Umit ; Olgun Demir ; Murat Kaya ; Tar K Akdemir ; Sümeyye CakmakSource :
- The American journal of emergency medicine [ 1532-8171 ] ; 2021.
English descriptors
- KwdEn :
- MESH :
- chemical , adverse effects : Hydroxychloroquine.
- drug therapy : COVID-19.
- chemical , therapeutic use : Hydroxychloroquine.
- Adult, Ambulatory Care, Female, Humans, Male, Middle Aged, Pilot Projects, Prospective Studies, Treatment Outcome.
Abstract
PURPOSE
We investigated the efficacy and safety of hydroxychloroquine for empirical treatment of outpatients with confirmed COVID-19.
METHODS
In this prospective, single-center study, we enrolled ambulatory outpatients with COVID-19 confirmed by a molecular method who received hydroxychloroquine. The patients were divided into low- and moderate-risk groups based on the Tisdale risk score for drug-associated QT prolongation, and the QT interval was corrected for heart rate using the Bazett formula (QTc). The QTc interval was measured by electrocardiography both pretreatment (QTc1) and 4 h after the administration of hydroxychloroquine (QTc2). The difference between the QTc1 and QTc2 intervals was defined as the ΔQTc. The QTc1 and QTc2 intervals and ΔQTc values were compared between the two risk groups.
RESULTS
The median and interquartile range (IQR) age of the patients was 47.0 (36.2-62) years, and there were 78 men and 74 women. The median (IQR) QTc1 interval lengthened from 425.0 (407.2-425.0) to 430.0 (QTc2; 412.0-443.0) milliseconds (ms). However, this was not considered an increased risk of ventricular tachycardia associated with a prolonged QTc interval requiring drug discontinuation, because none of the patients had a ΔQTc of >60 ms or a QTc2 of >500 ms. Moreover, the median (quartiles; minimum-maximum) ΔQTc value was higher in patients in the moderate-risk group than those in the low-risk group (10.0 [-4.0-18.0; -75.0-51.0] vs. 7.0 [-10.5-23.5; -53.0-59.0 ms]) (p = 0.996). Clinical improvement was noted in 91.4% of the patients, the exceptions being 13 patients who presented with non-serious adverse drug reactions or who had severe COVID-19 and were hospitalized. Adverse effects related to hydroxychloroquine were non-serious and occurred in 52.8% (n = 80) of the patients.
CONCLUSIONS
Our findings show that hydroxychloroquine is safe for COVID-19 and not associated with a risk of ventricular arrhythmia due to drug-induced QTc interval prolongation. Additionally, hydroxychloroquine was well tolerated, and there were no drug-related non-serious adverse events leading to treatment discontinuation in the majority of patients who were stable and did not require hospitalization.
DOI: 10.1016/j.ajem.2020.12.014
PubMed: 33348222
PubMed Central: PMC7836768
Links to Exploration step
pubmed:33348222Le document en format XML
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<author><name sortKey="Sogut, Ozgur" sort="Sogut, Ozgur" uniqKey="Sogut O" first="Ozgur" last="Sogut">Ozgur Sogut</name>
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<term>COVID-19 (drug therapy)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Pilot Projects (MeSH)</term>
<term>Prospective Studies (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
</keywords>
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<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
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<front><div type="abstract" xml:lang="en"><p><b>PURPOSE</b>
</p>
<p>We investigated the efficacy and safety of hydroxychloroquine for empirical treatment of outpatients with confirmed COVID-19.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS</b>
</p>
<p>In this prospective, single-center study, we enrolled ambulatory outpatients with COVID-19 confirmed by a molecular method who received hydroxychloroquine. The patients were divided into low- and moderate-risk groups based on the Tisdale risk score for drug-associated QT prolongation, and the QT interval was corrected for heart rate using the Bazett formula (QTc). The QTc interval was measured by electrocardiography both pretreatment (QTc1) and 4 h after the administration of hydroxychloroquine (QTc2). The difference between the QTc1 and QTc2 intervals was defined as the ΔQTc. The QTc1 and QTc2 intervals and ΔQTc values were compared between the two risk groups.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>The median and interquartile range (IQR) age of the patients was 47.0 (36.2-62) years, and there were 78 men and 74 women. The median (IQR) QTc1 interval lengthened from 425.0 (407.2-425.0) to 430.0 (QTc2; 412.0-443.0) milliseconds (ms). However, this was not considered an increased risk of ventricular tachycardia associated with a prolonged QTc interval requiring drug discontinuation, because none of the patients had a ΔQTc of >60 ms or a QTc2 of >500 ms. Moreover, the median (quartiles; minimum-maximum) ΔQTc value was higher in patients in the moderate-risk group than those in the low-risk group (10.0 [-4.0-18.0; -75.0-51.0] vs. 7.0 [-10.5-23.5; -53.0-59.0 ms]) (p = 0.996). Clinical improvement was noted in 91.4% of the patients, the exceptions being 13 patients who presented with non-serious adverse drug reactions or who had severe COVID-19 and were hospitalized. Adverse effects related to hydroxychloroquine were non-serious and occurred in 52.8% (n = 80) of the patients.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b>
</p>
<p>Our findings show that hydroxychloroquine is safe for COVID-19 and not associated with a risk of ventricular arrhythmia due to drug-induced QTc interval prolongation. Additionally, hydroxychloroquine was well tolerated, and there were no drug-related non-serious adverse events leading to treatment discontinuation in the majority of patients who were stable and did not require hospitalization.</p>
</div>
</front>
</TEI>
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<Title>The American journal of emergency medicine</Title>
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<ArticleTitle>Safety and efficacy of hydroxychloroquine in 152 outpatients with confirmed COVID-19: A pilot observational study.</ArticleTitle>
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<Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">We investigated the efficacy and safety of hydroxychloroquine for empirical treatment of outpatients with confirmed COVID-19.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In this prospective, single-center study, we enrolled ambulatory outpatients with COVID-19 confirmed by a molecular method who received hydroxychloroquine. The patients were divided into low- and moderate-risk groups based on the Tisdale risk score for drug-associated QT prolongation, and the QT interval was corrected for heart rate using the Bazett formula (QTc). The QTc interval was measured by electrocardiography both pretreatment (QTc1) and 4 h after the administration of hydroxychloroquine (QTc2). The difference between the QTc1 and QTc2 intervals was defined as the ΔQTc. The QTc1 and QTc2 intervals and ΔQTc values were compared between the two risk groups.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The median and interquartile range (IQR) age of the patients was 47.0 (36.2-62) years, and there were 78 men and 74 women. The median (IQR) QTc1 interval lengthened from 425.0 (407.2-425.0) to 430.0 (QTc2; 412.0-443.0) milliseconds (ms). However, this was not considered an increased risk of ventricular tachycardia associated with a prolonged QTc interval requiring drug discontinuation, because none of the patients had a ΔQTc of >60 ms or a QTc2 of >500 ms. Moreover, the median (quartiles; minimum-maximum) ΔQTc value was higher in patients in the moderate-risk group than those in the low-risk group (10.0 [-4.0-18.0; -75.0-51.0] vs. 7.0 [-10.5-23.5; -53.0-59.0 ms]) (p = 0.996). Clinical improvement was noted in 91.4% of the patients, the exceptions being 13 patients who presented with non-serious adverse drug reactions or who had severe COVID-19 and were hospitalized. Adverse effects related to hydroxychloroquine were non-serious and occurred in 52.8% (n = 80) of the patients.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Our findings show that hydroxychloroquine is safe for COVID-19 and not associated with a risk of ventricular arrhythmia due to drug-induced QTc interval prolongation. Additionally, hydroxychloroquine was well tolerated, and there were no drug-related non-serious adverse events leading to treatment discontinuation in the majority of patients who were stable and did not require hospitalization.</AbstractText>
<CopyrightInformation>Copyright © 2020 Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sogut</LastName>
<ForeName>Ozgur</ForeName>
<Initials>O</Initials>
<AffiliationInfo><Affiliation>University of Health Sciences, Haseki Training and Research Hospital, Department of Emergency Medicine, Istanbul, Turkey. Electronic address: ozgur.sogut@sbu.edu.tr.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Can</LastName>
<ForeName>Mehmet Mustafa</ForeName>
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<AffiliationInfo><Affiliation>University of Health Sciences, Haseki Training and Research Hospital, Department of Cardiology, Istanbul, Turkey.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Guven</LastName>
<ForeName>Ramazan</ForeName>
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</AffiliationInfo>
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</AffiliationInfo>
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<ForeName>Hüseyin</ForeName>
<Initials>H</Initials>
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</AffiliationInfo>
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<Initials>TB</Initials>
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<Initials>O</Initials>
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</AffiliationInfo>
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<ForeName>Murat</ForeName>
<Initials>M</Initials>
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</AffiliationInfo>
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<ForeName>Tarık</ForeName>
<Initials>T</Initials>
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</AffiliationInfo>
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<AffiliationInfo><Affiliation>University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital, Department of Emergency Medicine, Istanbul, Turkey.</Affiliation>
</AffiliationInfo>
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<Language>eng</Language>
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<MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
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<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010865" MajorTopicYN="N">Pilot Projects</DescriptorName>
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<MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
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<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword>
<Keyword MajorTopicYN="N">Hydroxychloroquine</Keyword>
<Keyword MajorTopicYN="N">QT interval</Keyword>
<Keyword MajorTopicYN="N">Ventricular arrhythmia</Keyword>
</KeywordList>
<CoiStatement>Declaration of Competing Interest None.</CoiStatement>
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