Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions

dc.contributor.authorSouza Botelho, Mayra [UNESP]
dc.contributor.authorBolfi, Fernanda [UNESP]
dc.contributor.authorLeite, Renata Giacomini Occhiuto Ferreira [UNESP]
dc.contributor.authorLeite, Mauro Salles Ferreira [UNESP]
dc.contributor.authorBanzato, Luisa Rocco [UNESP]
dc.contributor.authorSoares, Luiza Teixeira [UNESP]
dc.contributor.authorOlivatti, Thaina Oliveira Felicio [UNESP]
dc.contributor.authorMangolim, Amanda Sampaio [UNESP]
dc.contributor.authorOliveira, Flávia Ramos Kazan [UNESP]
dc.contributor.authorAbbade, Luciana Patrícia Fernandes [UNESP]
dc.contributor.authorAbbade, Joelcio Francisco [UNESP]
dc.contributor.authorde Barros Almeida, Ricardo Augusto Monteiro [UNESP]
dc.contributor.authorSimões Corrêa Galendi, Julia
dc.contributor.authorThabane, Lehana
dc.contributor.authordos Santos Nunes-Nogueira, Vania [UNESP]
dc.contributor.institutionUniversidade Estadual Paulista (UNESP)
dc.contributor.institutionUniversity of Cologne
dc.contributor.institutionMcMaster University
dc.contributor.institutionSt Joseph’s Healthcare-Hamilton
dc.contributor.institutionUniversity of Johannesburg
dc.date.accessioned2022-04-29T08:36:14Z
dc.date.available2022-04-29T08:36:14Z
dc.date.issued2021-12-01
dc.description.abstractBackground: Despite the expectations regarding the effectiveness of chloroquine (CQ) and hydroxychloroquine (HCQ) for coronavirus disease (COVID-19) management, concerns about their adverse events have remained. Objectives: The objective of this systematic review was to evaluate the safety of CQ and HCQ from malarial and non-malarial randomized clinical trials (RCTs). Methods: The primary outcomes were the frequencies of serious adverse events (SAEs), retinopathy, and cardiac complications. Search strategies were applied to MEDLINE, EMBASE, LILACS, CENTRAL, Scopus, and Trip databases. We used a random-effects model to pool results across studies and Peto’s one-step odds ratio (OR) for event rates below 1%. Both-armed zero-event studies were excluded from the meta-analyses. We used the Grading of Recommendations Assessment, Development, and Evaluation system to evaluate the certainty of evidence. Results: One hundred and six RCTs were included. We found no significant difference between CQ/HCQ and control (placebo or non-CQ/HCQ) in the frequency of SAEs (OR: 0.98, 95% confidence interval [CI]: 0.76–1.26, 33 trials, 15,942 participants, moderate certainty of evidence). However, there was a moderate certainty of evidence that CQ/HCQ increases the incidence of cardiac complications (RR: 1.62, 95% CI: 1.10–2.38, 16 trials, 9908 participants). No clear relationship was observed between CQ/HCQ and retinopathy (OR: 1.63, 95% CI: − 0.4–6.57, 5 trials, 344 participants, very low certainty of evidence). Conclusions: CQ and HCQ probably do not increase SAEs, with low frequency of these adverse events on malarial and non-malarial conditions. However, they may increase cardiac complications especially in patients with COVID-19. No clear effect of their use on the incidence of retinopathy was observed. Systematic review registration: PROSPERO CRD42020177818.en
dc.description.affiliationDepartment of Internal Medicine São Paulo State University/UNESP Medical School
dc.description.affiliationDepartment of Infectious Diseases Dermatology Imaging Diagnosis and Radiotherapy São Paulo State University/UNESP Medical School
dc.description.affiliationDepartment of Gynecology and Obstetrics São Paulo State University/UNESP Medical School
dc.description.affiliationInstitute of Health Economics and Clinical Epidemiology Faculty of Medicine and University Hospital of Cologne University of Cologne
dc.description.affiliationDepartment of Health Research Methods Evidence and Impact McMaster University
dc.description.affiliationBiostatistics Unit St Joseph’s Healthcare-Hamilton
dc.description.affiliationFaculty of Health Sciences University of Johannesburg
dc.description.affiliationUnespDepartment of Internal Medicine São Paulo State University/UNESP Medical School
dc.description.affiliationUnespDepartment of Infectious Diseases Dermatology Imaging Diagnosis and Radiotherapy São Paulo State University/UNESP Medical School
dc.description.affiliationUnespDepartment of Gynecology and Obstetrics São Paulo State University/UNESP Medical School
dc.identifierhttp://dx.doi.org/10.1186/s13643-021-01835-x
dc.identifier.citationSystematic Reviews, v. 10, n. 1, 2021.
dc.identifier.doi10.1186/s13643-021-01835-x
dc.identifier.issn2046-4053
dc.identifier.scopus2-s2.0-85118696534
dc.identifier.urihttp://hdl.handle.net/11449/229850
dc.language.isoeng
dc.relation.ispartofSystematic Reviews
dc.sourceScopus
dc.subjectAdverse effects
dc.subjectChloroquine
dc.subjectCOVID-19
dc.subjectHydroxychloroquine
dc.subjectSafety
dc.subjectSystematic review
dc.titleSystematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditionsen
dc.typeArtigo
unesp.author.orcid0000-0001-9316-4167[15]

Arquivos