Botelho, Mayra Souza, Bolfi, Fernanda, Occhiuto Ferreira Leite, Renata Giacomini, Ferreira Leite, Mauro Salles, Banzato, Luisa Rocco, Soares, Luiza Teixeira, Felicio Olivatti, Thaina Oliveira, Mangolim, Amanda Sampaio, Kazan Oliveira, Flavia Ramos, Fernandes Abbade, Luciana Patricia, Abbade, Joelcio Francisco, Monteiro de Barros Almeida, Ricardo Augusto 
ORCID: 0000-0003-0567-6221, Correa Galendi, Julia Simoes, Thabane, Lehana and Nunes-Nogueira, Vania dos Santos
(2021).
Systematic review and meta-analysis of the safety of chloroquine and hydroxychloroquine from randomized controlled trials on malarial and non-malarial conditions.
Syst. Rev., 10 (1).
LONDON:
BMC.
ISSN 2046-4053
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.
| Item Type: | Journal Article | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Creators: |
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| URN: | urn:nbn:de:hbz:38-588073 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| DOI: | 10.1186/s13643-021-01835-x | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Journal or Publication Title: | Syst. Rev. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Volume: | 10 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Number: | 1 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Date: | 2021 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Publisher: | BMC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Place of Publication: | LONDON | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ISSN: | 2046-4053 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Language: | English | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Faculty: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Divisions: | Unspecified | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Subjects: | no entry | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| URI: | http://kups.ub.uni-koeln.de/id/eprint/58807 |
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