Assessment of Chloroquine and Hydroxychloroquine Safety Profiles: A Systematic Review and Meta-Analysis.
Identifieur interne : 000883 ( Main/Corpus ); précédent : 000882; suivant : 000884Assessment of Chloroquine and Hydroxychloroquine Safety Profiles: A Systematic Review and Meta-Analysis.
Auteurs : Lu Ren ; Wilson Xu ; James L. Overton ; Shandong Yu ; Nipavan Chiamvimonvat ; Phung N. ThaiSource :
- Frontiers in pharmacology [ 1663-9812 ] ; 2020.
Abstract
Background
Chloroquine (CQ) and its derivative hydroxychloroquine (HCQ) have recently emerged as potential antiviral and immunomodulatory options for the treatment of 2019 coronavirus disease (COVID-19). To examine the safety profiles of these medications, we systematically evaluated the adverse events (AEs) of these medications from published randomized controlled trials (RCTs).
Methods
We systematically searched MEDLINE, the Cochrane library, the Cochrane Central Register of Controlled Trials (CENTRAL), and the ClinicalTrials.gov for all the RCTs comparing CQ or HCQ with placebo or other active agents, published before June 20, 2020. The random-effects or fixed-effects models were used to pool the risk estimates relative ratio (RR) with 95% confidence interval (CI) for the outcomes.
Results
The literature search yielded 23 and 19 studies for CQ and HCQ, respectively, that satisfied our inclusion criteria. Of these studies, we performed meta-analysis on 6 studies for CQ and 18 studies for HCQ. We did not limit our analysis to published records involving viral treatment alone; data also included the usage of either CQ or HCQ for the treatment of other diseases. The trials for the CQ consisted of a total of 2,137 participants (n = 1,077 CQ, n = 1,060 placebo), while the trials for HCQ involved 2,675 participants (n = 1,345 HCQ and n = 1,330 control). The overall mild and total AEs were significantly higher in CQ-treated non-COVID-19 patients, HCQ-treated non-COVID-19 patients, and HCQ-treated COVID-19 patients. The AEs were further categorized into four groups and analyses revealed that neurologic, gastrointestinal (GI), dermatologic, and sensory AEs were higher in participants taking CQ compared to placebo, while GI, dermatologic, sensory, and cardiovascular AEs were higher in HCQ-treated COVID-19 patients compared to control patients. Moreover, subgroup analysis suggested higher AEs with respect to dosage and duration in HCQ group. Data were acquired from studies with perceived low risk of bias, so plausible bias is unlikely to seriously affect the main findings of the current study.
Conclusions
Taken together, we found that participants taking either CQ or HCQ exhibited more AEs than participants taking placebo or control. Precautionary measures should be taken when using these drugs to treat COVID-19. The meta-analysis was registered on OSF (https://osf.io/jm3d9).
Registration
The meta-analysis was registered on OSF (https://osf.io/jm3d9).
DOI: 10.3389/fphar.2020.562777
PubMed: 33154723
PubMed Central: PMC7591721
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pubmed:33154723Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Assessment of Chloroquine and Hydroxychloroquine Safety Profiles: A Systematic Review and Meta-Analysis.</title><author><name sortKey="Ren, Lu" sort="Ren, Lu" uniqKey="Ren L" first="Lu" last="Ren">Lu Ren</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Xu, Wilson" sort="Xu, Wilson" uniqKey="Xu W" first="Wilson" last="Xu">Wilson Xu</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Overton, James L" sort="Overton, James L" uniqKey="Overton J" first="James L" last="Overton">James L. Overton</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Yu, Shandong" sort="Yu, Shandong" uniqKey="Yu S" first="Shandong" last="Yu">Shandong Yu</name><affiliation><nlm:affiliation>Department of Cardiology, Cardiovascular Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chiamvimonvat, Nipavan" sort="Chiamvimonvat, Nipavan" uniqKey="Chiamvimonvat N" first="Nipavan" last="Chiamvimonvat">Nipavan Chiamvimonvat</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Veteran Affairs, Northern California Health Care System, Mather, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Thai, Phung N" sort="Thai, Phung N" uniqKey="Thai P" first="Phung N" last="Thai">Phung N. Thai</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33154723</idno><idno type="pmid">33154723</idno><idno type="doi">10.3389/fphar.2020.562777</idno><idno type="pmc">PMC7591721</idno><idno type="wicri:Area/Main/Corpus">000883</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000883</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Assessment of Chloroquine and Hydroxychloroquine Safety Profiles: A Systematic Review and Meta-Analysis.</title><author><name sortKey="Ren, Lu" sort="Ren, Lu" uniqKey="Ren L" first="Lu" last="Ren">Lu Ren</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Xu, Wilson" sort="Xu, Wilson" uniqKey="Xu W" first="Wilson" last="Xu">Wilson Xu</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Overton, James L" sort="Overton, James L" uniqKey="Overton J" first="James L" last="Overton">James L. Overton</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Yu, Shandong" sort="Yu, Shandong" uniqKey="Yu S" first="Shandong" last="Yu">Shandong Yu</name><affiliation><nlm:affiliation>Department of Cardiology, Cardiovascular Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.</nlm:affiliation></affiliation></author><author><name sortKey="Chiamvimonvat, Nipavan" sort="Chiamvimonvat, Nipavan" uniqKey="Chiamvimonvat N" first="Nipavan" last="Chiamvimonvat">Nipavan Chiamvimonvat</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Veteran Affairs, Northern California Health Care System, Mather, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Thai, Phung N" sort="Thai, Phung N" uniqKey="Thai P" first="Phung N" last="Thai">Phung N. Thai</name><affiliation><nlm:affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Frontiers in pharmacology</title><idno type="ISSN">1663-9812</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>Chloroquine (CQ) and its derivative hydroxychloroquine (HCQ) have recently emerged as potential antiviral and immunomodulatory options for the treatment of 2019 coronavirus disease (COVID-19). To examine the safety profiles of these medications, we systematically evaluated the adverse events (AEs) of these medications from published randomized controlled trials (RCTs).</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>We systematically searched MEDLINE, the Cochrane library, the Cochrane Central Register of Controlled Trials (CENTRAL), and the ClinicalTrials.gov for all the RCTs comparing CQ or HCQ with placebo or other active agents, published before June 20, 2020. The random-effects or fixed-effects models were used to pool the risk estimates relative ratio (RR) with 95% confidence interval (CI) for the outcomes.</p></div><div type="abstract" xml:lang="en"><p><b>Results</b></p><p>The literature search yielded 23 and 19 studies for CQ and HCQ, respectively, that satisfied our inclusion criteria. Of these studies, we performed meta-analysis on 6 studies for CQ and 18 studies for HCQ. We did not limit our analysis to published records involving viral treatment alone; data also included the usage of either CQ or HCQ for the treatment of other diseases. The trials for the CQ consisted of a total of 2,137 participants (n = 1,077 CQ, n = 1,060 placebo), while the trials for HCQ involved 2,675 participants (n = 1,345 HCQ and n = 1,330 control). The overall mild and total AEs were significantly higher in CQ-treated non-COVID-19 patients, HCQ-treated non-COVID-19 patients, and HCQ-treated COVID-19 patients. The AEs were further categorized into four groups and analyses revealed that neurologic, gastrointestinal (GI), dermatologic, and sensory AEs were higher in participants taking CQ compared to placebo, while GI, dermatologic, sensory, and cardiovascular AEs were higher in HCQ-treated COVID-19 patients compared to control patients. Moreover, subgroup analysis suggested higher AEs with respect to dosage and duration in HCQ group. Data were acquired from studies with perceived low risk of bias, so plausible bias is unlikely to seriously affect the main findings of the current study.</p></div><div type="abstract" xml:lang="en"><p><b>Conclusions</b></p><p>Taken together, we found that participants taking either CQ or HCQ exhibited more AEs than participants taking placebo or control. Precautionary measures should be taken when using these drugs to treat COVID-19. The meta-analysis was registered on OSF (https://osf.io/jm3d9).</p></div><div type="abstract" xml:lang="en"><p><b>Registration</b></p><p>The meta-analysis was registered on OSF (https://osf.io/jm3d9).</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33154723</PMID><DateRevised><Year>2020</Year><Month>11</Month><Day>07</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">1663-9812</ISSN><JournalIssue CitedMedium="Print"><Volume>11</Volume><PubDate><Year>2020</Year></PubDate></JournalIssue><Title>Frontiers in pharmacology</Title><ISOAbbreviation>Front Pharmacol</ISOAbbreviation></Journal><ArticleTitle>Assessment of Chloroquine and Hydroxychloroquine Safety Profiles: A Systematic Review and Meta-Analysis.</ArticleTitle><Pagination><MedlinePgn>562777</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3389/fphar.2020.562777</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">Chloroquine (CQ) and its derivative hydroxychloroquine (HCQ) have recently emerged as potential antiviral and immunomodulatory options for the treatment of 2019 coronavirus disease (COVID-19). To examine the safety profiles of these medications, we systematically evaluated the adverse events (AEs) of these medications from published randomized controlled trials (RCTs).</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">We systematically searched MEDLINE, the Cochrane library, the Cochrane Central Register of Controlled Trials (CENTRAL), and the ClinicalTrials.gov for all the RCTs comparing CQ or HCQ with placebo or other active agents, published before June 20, 2020. The random-effects or fixed-effects models were used to pool the risk estimates relative ratio (RR) with 95% confidence interval (CI) for the outcomes.</AbstractText><AbstractText Label="Results" NlmCategory="UNASSIGNED">The literature search yielded 23 and 19 studies for CQ and HCQ, respectively, that satisfied our inclusion criteria. Of these studies, we performed meta-analysis on 6 studies for CQ and 18 studies for HCQ. We did not limit our analysis to published records involving viral treatment alone; data also included the usage of either CQ or HCQ for the treatment of other diseases. The trials for the CQ consisted of a total of 2,137 participants (n = 1,077 CQ, n = 1,060 placebo), while the trials for HCQ involved 2,675 participants (n = 1,345 HCQ and n = 1,330 control). The overall mild and total AEs were significantly higher in CQ-treated non-COVID-19 patients, HCQ-treated non-COVID-19 patients, and HCQ-treated COVID-19 patients. The AEs were further categorized into four groups and analyses revealed that neurologic, gastrointestinal (GI), dermatologic, and sensory AEs were higher in participants taking CQ compared to placebo, while GI, dermatologic, sensory, and cardiovascular AEs were higher in HCQ-treated COVID-19 patients compared to control patients. Moreover, subgroup analysis suggested higher AEs with respect to dosage and duration in HCQ group. Data were acquired from studies with perceived low risk of bias, so plausible bias is unlikely to seriously affect the main findings of the current study.</AbstractText><AbstractText Label="Conclusions" NlmCategory="UNASSIGNED">Taken together, we found that participants taking either CQ or HCQ exhibited more AEs than participants taking placebo or control. Precautionary measures should be taken when using these drugs to treat COVID-19. The meta-analysis was registered on OSF (https://osf.io/jm3d9).</AbstractText><AbstractText Label="Registration" NlmCategory="UNASSIGNED">The meta-analysis was registered on OSF (https://osf.io/jm3d9).</AbstractText><CopyrightInformation>Copyright © 2020 Ren, Xu, Overton, Yu, Chiamvimonvat and Thai.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ren</LastName><ForeName>Lu</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Xu</LastName><ForeName>Wilson</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Overton</LastName><ForeName>James L</ForeName><Initials>JL</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yu</LastName><ForeName>Shandong</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Cardiology, Cardiovascular Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chiamvimonvat</LastName><ForeName>Nipavan</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine, Cardiology, University of California, Davis, Davis, CA, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Veteran Affairs, Northern California Health Care System, Mather, CA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Thai</LastName><ForeName>Phung 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