Hydroxychloroquine safety: A meta-analysis of randomized controlled trials.
Identifieur interne : 000878 ( Main/Exploration ); précédent : 000877; suivant : 000879Hydroxychloroquine safety: A meta-analysis of randomized controlled trials.
Auteurs : Khalid Eljaaly [États-Unis] ; Kasim Huseein Alireza [Arabie saoudite] ; Samah Alshehri [États-Unis] ; Jaffar A. Al-Tawfiq [États-Unis]Source :
- Travel medicine and infectious disease [ 1873-0442 ]
Descripteurs français
- KwdFr :
- Antirhumatismaux (effets indésirables), Arthrose (traitement médicamenteux), Betacoronavirus (MeSH), Céphalée (induit chimiquement), Essais contrôlés randomisés comme sujet (MeSH), Exanthème (induit chimiquement), Fatigue (induit chimiquement), Glomérulonéphrite à dépôts d'IgA (traitement médicamenteux), Humains (MeSH), Hydroxychloroquine (effets indésirables), Hyperpigmentation (induit chimiquement), Infections asymptomatiques (MeSH), Infections à VIH (traitement médicamenteux), Infections à coronavirus (traitement médicamenteux), Lupus érythémateux cutané (traitement médicamenteux), Lupus érythémateux disséminé (traitement médicamenteux), Maladie d'Alzheimer (traitement médicamenteux), Maladies gastro-intestinales (induit chimiquement), Pandémies (MeSH), Pneumopathie virale (traitement médicamenteux), Polyarthrite rhumatoïde (traitement médicamenteux), Rhumatismes (traitement médicamenteux), Sensation vertigineuse (induit chimiquement).
- MESH :
- effets indésirables : Antirhumatismaux, Hydroxychloroquine.
- induit chimiquement : Céphalée, Exanthème, Fatigue, Hyperpigmentation, Maladies gastro-intestinales, Sensation vertigineuse.
- traitement médicamenteux : Arthrose, Glomérulonéphrite à dépôts d'IgA, Infections à VIH, Infections à coronavirus, Lupus érythémateux cutané, Lupus érythémateux disséminé, Maladie d'Alzheimer, Pneumopathie virale, Polyarthrite rhumatoïde, Rhumatismes.
- Betacoronavirus, Essais contrôlés randomisés comme sujet, Humains, Infections asymptomatiques, Pandémies.
English descriptors
- KwdEn :
- Alzheimer Disease (drug therapy), Antirheumatic Agents (adverse effects), Arthritis, Rheumatoid (drug therapy), Asymptomatic Infections (MeSH), Betacoronavirus (MeSH), COVID-19 (MeSH), Chronic Urticaria (drug therapy), Coronavirus Infections (drug therapy), Dizziness (chemically induced), Exanthema (chemically induced), Fatigue (chemically induced), Gastrointestinal Diseases (chemically induced), Glomerulonephritis, IGA (drug therapy), HIV Infections (drug therapy), Headache (chemically induced), Humans (MeSH), Hydroxychloroquine (adverse effects), Hyperpigmentation (chemically induced), Lupus Erythematosus, Cutaneous (drug therapy), Lupus Erythematosus, Systemic (drug therapy), Osteoarthritis (drug therapy), Pandemics (MeSH), Pneumonia, Viral (drug therapy), Randomized Controlled Trials as Topic (MeSH), Rheumatic Diseases (drug therapy), SARS-CoV-2 (MeSH).
- MESH :
- chemical , adverse effects : Antirheumatic Agents, Hydroxychloroquine.
- chemically induced : Dizziness, Exanthema, Fatigue, Gastrointestinal Diseases, Headache, Hyperpigmentation.
- drug therapy : Alzheimer Disease, Arthritis, Rheumatoid, Chronic Urticaria, Coronavirus Infections, Glomerulonephritis, IGA, HIV Infections, Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Osteoarthritis, Pneumonia, Viral, Rheumatic Diseases.
- Asymptomatic Infections, Betacoronavirus, COVID-19, Humans, Pandemics, Randomized Controlled Trials as Topic, SARS-CoV-2.
Abstract
BACKGROUND
Hydroxychloroquine (HCQ) is currently being examined for COVID-19. No previous meta-analysis has evaluated its side effects versus placebo. We conducted this meta-analysis to compare the safety of HCQ versus placebo.
METHODS
Two authors independently searched PubMed and EMBASE databases for randomized controlled trials (RCTs) of adults comparing the adverse events (AEs) of HCQ versus placebo for any indication. Peto odds ratios (Peto ORs) and 95% confidence intervals (CIs) were calculated based on random-effects models. The heterogeneity (I
RESULTS
Nine RCTs (eight were double-blind) with a total of 916 patients were included. HCQ caused significantly more skin pigmentation than placebo (Peto OR, 4.64; 95% CI, 1.13 to 19.00; P-value = 0.033; I
CONCLUSIONS
This meta-analysis of RCTs found a significantly higher risk of skin pigmentation in HCQ users versus placebo. More data are needed to evaluate HCQ in the context of COVID-19 treatment.
DOI: 10.1016/j.tmaid.2020.101812
PubMed: 32645478
PubMed Central: PMC7342171
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Electronic address: khalid-eljaaly@live.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of Pharmacy, University of Arizona, Tucson, AZ</wicri:regionArea><placeName><region type="state">Arizona</region></placeName></affiliation></author><author><name sortKey="Alireza, Kasim Huseein" sort="Alireza, Kasim Huseein" uniqKey="Alireza K" first="Kasim Huseein" last="Alireza">Kasim Huseein Alireza</name><affiliation wicri:level="1"><nlm:affiliation>Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.</nlm:affiliation><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Faculty of Pharmacy, King Abdulaziz University, Jeddah</wicri:regionArea><wicri:noRegion>Jeddah</wicri:noRegion></affiliation></author><author><name sortKey="Alshehri, Samah" sort="Alshehri, Samah" uniqKey="Alshehri S" first="Samah" last="Alshehri">Samah Alshehri</name><affiliation wicri:level="2"><nlm:affiliation>Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of Pharmacy, University of Arizona, Tucson, AZ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of Pharmacy, University of Arizona, Tucson, AZ</wicri:regionArea><placeName><region type="state">Arizona</region></placeName></affiliation></author><author><name sortKey="Al Tawfiq, Jaffar A" sort="Al Tawfiq, Jaffar A" uniqKey="Al Tawfiq J" first="Jaffar A" last="Al-Tawfiq">Jaffar A. Al-Tawfiq</name><affiliation wicri:level="2"><nlm:affiliation>Infectious Disease Unit, Specialty Internal Medicine, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Infectious Disease Unit, Specialty Internal Medicine, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author></analytic><series><title level="j">Travel medicine and infectious disease</title><idno type="eISSN">1873-0442</idno></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Alzheimer Disease (drug therapy)</term><term>Antirheumatic Agents (adverse effects)</term><term>Arthritis, Rheumatoid (drug therapy)</term><term>Asymptomatic Infections (MeSH)</term><term>Betacoronavirus (MeSH)</term><term>COVID-19 (MeSH)</term><term>Chronic Urticaria (drug therapy)</term><term>Coronavirus Infections (drug therapy)</term><term>Dizziness (chemically induced)</term><term>Exanthema (chemically induced)</term><term>Fatigue (chemically induced)</term><term>Gastrointestinal Diseases (chemically induced)</term><term>Glomerulonephritis, IGA (drug therapy)</term><term>HIV Infections (drug therapy)</term><term>Headache (chemically induced)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (adverse effects)</term><term>Hyperpigmentation (chemically induced)</term><term>Lupus Erythematosus, Cutaneous (drug therapy)</term><term>Lupus Erythematosus, Systemic (drug therapy)</term><term>Osteoarthritis (drug therapy)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (drug therapy)</term><term>Randomized Controlled Trials as Topic (MeSH)</term><term>Rheumatic Diseases (drug therapy)</term><term>SARS-CoV-2 (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Antirhumatismaux (effets indésirables)</term><term>Arthrose (traitement médicamenteux)</term><term>Betacoronavirus (MeSH)</term><term>Céphalée (induit chimiquement)</term><term>Essais contrôlés randomisés comme sujet (MeSH)</term><term>Exanthème (induit chimiquement)</term><term>Fatigue (induit chimiquement)</term><term>Glomérulonéphrite à dépôts d'IgA (traitement médicamenteux)</term><term>Humains (MeSH)</term><term>Hydroxychloroquine (effets indésirables)</term><term>Hyperpigmentation (induit chimiquement)</term><term>Infections asymptomatiques (MeSH)</term><term>Infections à VIH (traitement médicamenteux)</term><term>Infections à coronavirus (traitement médicamenteux)</term><term>Lupus érythémateux cutané (traitement médicamenteux)</term><term>Lupus érythémateux disséminé (traitement médicamenteux)</term><term>Maladie d'Alzheimer (traitement médicamenteux)</term><term>Maladies gastro-intestinales (induit chimiquement)</term><term>Pandémies (MeSH)</term><term>Pneumopathie virale (traitement médicamenteux)</term><term>Polyarthrite rhumatoïde (traitement médicamenteux)</term><term>Rhumatismes (traitement médicamenteux)</term><term>Sensation vertigineuse (induit chimiquement)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antirheumatic Agents</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Dizziness</term><term>Exanthema</term><term>Fatigue</term><term>Gastrointestinal Diseases</term><term>Headache</term><term>Hyperpigmentation</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Alzheimer Disease</term><term>Arthritis, Rheumatoid</term><term>Chronic Urticaria</term><term>Coronavirus Infections</term><term>Glomerulonephritis, IGA</term><term>HIV Infections</term><term>Lupus Erythematosus, Cutaneous</term><term>Lupus Erythematosus, Systemic</term><term>Osteoarthritis</term><term>Pneumonia, Viral</term><term>Rheumatic Diseases</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antirhumatismaux</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr"><term>Céphalée</term><term>Exanthème</term><term>Fatigue</term><term>Hyperpigmentation</term><term>Maladies gastro-intestinales</term><term>Sensation vertigineuse</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Arthrose</term><term>Glomérulonéphrite à dépôts d'IgA</term><term>Infections à VIH</term><term>Infections à coronavirus</term><term>Lupus érythémateux cutané</term><term>Lupus érythémateux disséminé</term><term>Maladie d'Alzheimer</term><term>Pneumopathie virale</term><term>Polyarthrite rhumatoïde</term><term>Rhumatismes</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Asymptomatic Infections</term><term>Betacoronavirus</term><term>COVID-19</term><term>Humans</term><term>Pandemics</term><term>Randomized Controlled Trials as Topic</term><term>SARS-CoV-2</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Betacoronavirus</term><term>Essais contrôlés randomisés comme sujet</term><term>Humains</term><term>Infections asymptomatiques</term><term>Pandémies</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Hydroxychloroquine (HCQ) is currently being examined for COVID-19. No previous meta-analysis has evaluated its side effects versus placebo. We conducted this meta-analysis to compare the safety of HCQ versus placebo.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>Two authors independently searched PubMed and EMBASE databases for randomized controlled trials (RCTs) of adults comparing the adverse events (AEs) of HCQ versus placebo for any indication. Peto odds ratios (Peto ORs) and 95% confidence intervals (CIs) were calculated based on random-effects models. The heterogeneity (I</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>Nine RCTs (eight were double-blind) with a total of 916 patients were included. HCQ caused significantly more skin pigmentation than placebo (Peto OR, 4.64; 95% CI, 1.13 to 19.00; P-value = 0.033; I</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>This meta-analysis of RCTs found a significantly higher risk of skin pigmentation in HCQ users versus placebo. More data are needed to evaluate HCQ in the context of COVID-19 treatment.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32645478</PMID><DateCompleted><Year>2020</Year><Month>09</Month><Day>24</Day></DateCompleted><DateRevised><Year>2021</Year><Month>01</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-0442</ISSN><JournalIssue CitedMedium="Internet"><Volume>36</Volume><PubDate><MedlineDate>2020 Jul - Aug</MedlineDate></PubDate></JournalIssue><Title>Travel medicine and infectious disease</Title><ISOAbbreviation>Travel Med Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Hydroxychloroquine safety: A meta-analysis of randomized controlled trials.</ArticleTitle><Pagination><MedlinePgn>101812</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1477-8939(20)30308-2</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.tmaid.2020.101812</ELocationID><Abstract><AbstractText Label="BACKGROUND">Hydroxychloroquine (HCQ) is currently being examined for COVID-19. No previous meta-analysis has evaluated its side effects versus placebo. We conducted this meta-analysis to compare the safety of HCQ versus placebo.</AbstractText><AbstractText Label="METHODS">Two authors independently searched PubMed and EMBASE databases for randomized controlled trials (RCTs) of adults comparing the adverse events (AEs) of HCQ versus placebo for any indication. Peto odds ratios (Peto ORs) and 95% confidence intervals (CIs) were calculated based on random-effects models. The heterogeneity (I<sup>2</sup>) was assessed using Cochran's Q test.</AbstractText><AbstractText Label="RESULTS">Nine RCTs (eight were double-blind) with a total of 916 patients were included. HCQ caused significantly more skin pigmentation than placebo (Peto OR, 4.64; 95% CI, 1.13 to 19.00; P-value = 0.033; I<sup>2</sup> = 0%). The increase in other AEs did not reach statistical significance: rash (Peto OR, 1.11; 95% CI, 0.3 to 3.77; P-value = 0.03; I<sup>2</sup> = 0%); gastrointestinal AEs (Peto OR, 1.43; 95% CI, 0.55 to 3.72; P-value = 0.46; I<sup>2</sup> = 15.17%); headache (Peto OR, 1.94; 95% CI, 0.65 to 5.78; P-value = 0.23; I<sup>2</sup> = 9.99%); dizziness (Peto OR, 1.32; 95% CI, 0.49 to 3.52; P-value = 0.58; I<sup>2</sup> = 0%); fatigue (Peto OR, 2.13; 95% CI, 0.76 to 5.98; P-value = 0.15; I<sup>2</sup> = 0%); and visual AEs (Peto OR, 1.61; 95% CI, 0.76 to 3.41; P-value = 0.22; I<sup>2</sup> = 0%). Cardiac toxicity was not reported.</AbstractText><AbstractText Label="CONCLUSIONS">This meta-analysis of RCTs found a significantly higher risk of skin pigmentation in HCQ users versus placebo. More data are needed to evaluate HCQ in the context of COVID-19 treatment.</AbstractText><CopyrightInformation>Copyright © 2020 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Eljaaly</LastName><ForeName>Khalid</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of Pharmacy, University of Arizona, Tucson, AZ, USA. Electronic address: khalid-eljaaly@live.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Alireza</LastName><ForeName>Kasim Huseein</ForeName><Initials>KH</Initials><AffiliationInfo><Affiliation>Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Alshehri</LastName><ForeName>Samah</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia; College of Pharmacy, University of Arizona, Tucson, AZ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Al-Tawfiq</LastName><ForeName>Jaffar A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Infectious Disease Unit, Specialty Internal Medicine, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia; Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D017418">Meta-Analysis</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>07</Month><Day>06</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Travel Med Infect Dis</MedlineTA><NlmUniqueID>101230758</NlmUniqueID><ISSNLinking>1477-8939</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018501">Antirheumatic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber><NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Protocol" UI="C000705127">COVID-19 drug treatment</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000544" MajorTopicYN="N">Alzheimer Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018501" MajorTopicYN="N">Antirheumatic Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001172" MajorTopicYN="N">Arthritis, Rheumatoid</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058345" MajorTopicYN="N">Asymptomatic Infections</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000080223" MajorTopicYN="N">Chronic Urticaria</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="N">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004244" MajorTopicYN="N">Dizziness</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005076" MajorTopicYN="N">Exanthema</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005221" MajorTopicYN="N">Fatigue</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005767" 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