Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions
Abstract Background 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...
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2021
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oai:doaj.org-article:6587e379eb1d4b88af093fd3a5d965cd2021-11-07T12:08:13ZSystematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions10.1186/s13643-021-01835-x2046-4053https://doaj.org/article/6587e379eb1d4b88af093fd3a5d965cd2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13643-021-01835-xhttps://doaj.org/toc/2046-4053Abstract Background 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 CRD42020177818Mayra Souza BotelhoFernanda BolfiRenata Giacomini Occhiuto Ferreira LeiteMauro Salles Ferreira LeiteLuisa Rocco BanzatoLuiza Teixeira SoaresThaina Oliveira Felicio OlivattiAmanda Sampaio MangolimFlávia Ramos Kazan OliveiraLuciana Patrícia Fernandes AbbadeJoelcio Francisco AbbadeRicardo Augusto Monteiro de Barros AlmeidaJulia Simões Corrêa GalendiLehana ThabaneVania dos Santos Nunes-NogueiraBMCarticleChloroquineHydroxychloroquineCOVID-19Adverse effectsSafetySystematic reviewMedicineRENSystematic Reviews, Vol 10, Iss 1, Pp 1-19 (2021) |
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DOAJ |
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EN |
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Chloroquine Hydroxychloroquine COVID-19 Adverse effects Safety Systematic review Medicine R |
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Chloroquine Hydroxychloroquine COVID-19 Adverse effects Safety Systematic review Medicine R Mayra Souza Botelho Fernanda Bolfi Renata Giacomini Occhiuto Ferreira Leite Mauro Salles Ferreira Leite Luisa Rocco Banzato Luiza Teixeira Soares Thaina Oliveira Felicio Olivatti Amanda Sampaio Mangolim Flávia Ramos Kazan Oliveira Luciana Patrícia Fernandes Abbade Joelcio Francisco Abbade Ricardo Augusto Monteiro de Barros Almeida Julia Simões Corrêa Galendi Lehana Thabane Vania dos Santos Nunes-Nogueira Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions |
| description |
Abstract Background 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 |
| format |
article |
| author |
Mayra Souza Botelho Fernanda Bolfi Renata Giacomini Occhiuto Ferreira Leite Mauro Salles Ferreira Leite Luisa Rocco Banzato Luiza Teixeira Soares Thaina Oliveira Felicio Olivatti Amanda Sampaio Mangolim Flávia Ramos Kazan Oliveira Luciana Patrícia Fernandes Abbade Joelcio Francisco Abbade Ricardo Augusto Monteiro de Barros Almeida Julia Simões Corrêa Galendi Lehana Thabane Vania dos Santos Nunes-Nogueira |
| author_facet |
Mayra Souza Botelho Fernanda Bolfi Renata Giacomini Occhiuto Ferreira Leite Mauro Salles Ferreira Leite Luisa Rocco Banzato Luiza Teixeira Soares Thaina Oliveira Felicio Olivatti Amanda Sampaio Mangolim Flávia Ramos Kazan Oliveira Luciana Patrícia Fernandes Abbade Joelcio Francisco Abbade Ricardo Augusto Monteiro de Barros Almeida Julia Simões Corrêa Galendi Lehana Thabane Vania dos Santos Nunes-Nogueira |
| author_sort |
Mayra Souza Botelho |
| title |
Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions |
| title_short |
Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions |
| title_full |
Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions |
| title_fullStr |
Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions |
| title_full_unstemmed |
Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions |
| title_sort |
systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions |
| publisher |
BMC |
| publishDate |
2021 |
| url |
https://doaj.org/article/6587e379eb1d4b88af093fd3a5d965cd |
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