A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine
| Autor(a) principal: | |
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| Data de Publicação: | 2021 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
| Texto Completo: | http://hdl.handle.net/10362/147426 |
Resumo: | © European Association of Hospital Pharmacists 2021. No commercial re-use. See rights and permissions. Published by BMJ. |
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A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquinea preliminary reportSDG 3 - Good Health and Well-being© European Association of Hospital Pharmacists 2021. No commercial re-use. See rights and permissions. Published by BMJ.OBJECTIVES: Since the outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pressure to minimise its impact on public health has led to the implementation of different therapeutic strategies, the efficacy of which for the treatment of coronavirus disease 2019 (COVID-19) was unknown at the time. Remdesivir (REM) was granted its first conditional marketing authorisation in the EU in June 2020. The European Medicines Agency (EMA) and local health authorities all across the EU have since strongly recommended the implementation of pharmacovigilance activities aimed at further evaluating the safety of this new drug. The objective of this study was to evaluate adverse drug reactions (ADRs) attributed to either REM or hydroxychloroquine (HCQ) in patients hospitalised for COVID-19 in Centro Hospitalar de Lisboa Ocidental, a Portuguese hospital centre based in Lisbon. We present the preliminary results reporting plausible adverse effects of either HCQ or REM. METHODS: An observational cohort study was carried out between 16 March and 15 August 2020. Participants were divided into two cohorts: those prescribed an HCQ regimen, and those prescribed REM. Suspected ADRs were identified using an active monitoring model and reported to the Portuguese Pharmacovigilance System through its online notification tool. The ADR cumulative incidence was compared between the two cohorts. RESULTS: The study included 149 patients, of whom 101 were treated with HCQ and the remaining 48 with REM. The baseline characteristics were similar between the two cohorts. A total of 102 ADRs were identified during the study period, with a greater incidence in the HCQ cohort compared with the REM cohort (47.5% vs 12.5%; p<0.001). Causality was assessed in 81 ADRs, all of which were considered possible. CONCLUSIONS: Real-world data are crucial to further establish the safety profile for REM. HCQ is no longer recommended for the treatment of COVID-19.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNFalcão, FátimaViegas, EricaCarmo, InesSoares, JoanaFalcao, MargaridaSolano, MarianaCavaco, PatriciaMendes, DinaRijo, JoãoPovoa, PedroPais Martins, AntonioCarmo, EduardaMansinho, KamalFonseca, CandidaCampos, LuisCarvalho, AntónioMirco, AnaFarinha, HelenaAldir, IsabelCorreia, José2023-01-12T22:15:39Z2021-092021-09-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/147426eng2047-9956PURE: 27649217https://doi.org/10.1136/ejhpharm-2020-002613info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-03-11T05:28:31Zoai:run.unl.pt:10362/147426Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T03:52:55.100443Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
| dc.title.none.fl_str_mv |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine a preliminary report |
| title |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine |
| spellingShingle |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine Falcão, Fátima SDG 3 - Good Health and Well-being |
| title_short |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine |
| title_full |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine |
| title_fullStr |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine |
| title_full_unstemmed |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine |
| title_sort |
A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine |
| author |
Falcão, Fátima |
| author_facet |
Falcão, Fátima Viegas, Erica Carmo, Ines Soares, Joana Falcao, Margarida Solano, Mariana Cavaco, Patricia Mendes, Dina Rijo, João Povoa, Pedro Pais Martins, Antonio Carmo, Eduarda Mansinho, Kamal Fonseca, Candida Campos, Luis Carvalho, António Mirco, Ana Farinha, Helena Aldir, Isabel Correia, José |
| author_role |
author |
| author2 |
Viegas, Erica Carmo, Ines Soares, Joana Falcao, Margarida Solano, Mariana Cavaco, Patricia Mendes, Dina Rijo, João Povoa, Pedro Pais Martins, Antonio Carmo, Eduarda Mansinho, Kamal Fonseca, Candida Campos, Luis Carvalho, António Mirco, Ana Farinha, Helena Aldir, Isabel Correia, José |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) RUN |
| dc.contributor.author.fl_str_mv |
Falcão, Fátima Viegas, Erica Carmo, Ines Soares, Joana Falcao, Margarida Solano, Mariana Cavaco, Patricia Mendes, Dina Rijo, João Povoa, Pedro Pais Martins, Antonio Carmo, Eduarda Mansinho, Kamal Fonseca, Candida Campos, Luis Carvalho, António Mirco, Ana Farinha, Helena Aldir, Isabel Correia, José |
| dc.subject.por.fl_str_mv |
SDG 3 - Good Health and Well-being |
| topic |
SDG 3 - Good Health and Well-being |
| description |
© European Association of Hospital Pharmacists 2021. No commercial re-use. See rights and permissions. Published by BMJ. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2021-09 2021-09-01T00:00:00Z 2023-01-12T22:15:39Z |
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info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
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article |
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publishedVersion |
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http://hdl.handle.net/10362/147426 |
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http://hdl.handle.net/10362/147426 |
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eng |
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eng |
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2047-9956 PURE: 27649217 https://doi.org/10.1136/ejhpharm-2020-002613 |
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info:eu-repo/semantics/openAccess |
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openAccess |
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application/pdf |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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