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A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report.

Identifieur interne : 000477 ( Main/Corpus ); précédent : 000476; suivant : 000478

A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report.

Auteurs : Fátima Falcão ; Erica Viegas ; Ines Carmo ; Joana Soares ; Margarida Falcao ; Mariana Solano ; Patricia Cavaco ; Dina Mendes ; João Rijo ; Pedro Povoa ; Antonio Pais Martins ; Eduarda Carmo ; Kamal Mansinho ; Candida Fonseca ; Luis Campos ; Ant Nio Carvalho ; Ana Mirco ; Helena Farinha ; Isabel Aldir ; José Correia

Source :

RBID : pubmed:33452110

Abstract

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.


DOI: 10.1136/ejhpharm-2020-002613
PubMed: 33452110
PubMed Central: PMC7813046

Links to Exploration step

pubmed:33452110

Le document en format XML

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<name sortKey="Mansinho, Kamal" sort="Mansinho, Kamal" uniqKey="Mansinho K" first="Kamal" last="Mansinho">Kamal Mansinho</name>
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<nlm:affiliation>Infecciology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
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<title xml:lang="en">A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report.</title>
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<nlm:affiliation>Pharmacy Department, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
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<name sortKey="Soares, Joana" sort="Soares, Joana" uniqKey="Soares J" first="Joana" last="Soares">Joana Soares</name>
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<name sortKey="Falcao, Margarida" sort="Falcao, Margarida" uniqKey="Falcao M" first="Margarida" last="Falcao">Margarida Falcao</name>
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<nlm:affiliation>Pharmacy Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
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<name sortKey="Solano, Mariana" sort="Solano, Mariana" uniqKey="Solano M" first="Mariana" last="Solano">Mariana Solano</name>
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<nlm:affiliation>Pharmacy Department, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
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<name sortKey="Cavaco, Patricia" sort="Cavaco, Patricia" uniqKey="Cavaco P" first="Patricia" last="Cavaco">Patricia Cavaco</name>
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<nlm:affiliation>Pharmacy Department, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<name sortKey="Mendes, Dina" sort="Mendes, Dina" uniqKey="Mendes D" first="Dina" last="Mendes">Dina Mendes</name>
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<nlm:affiliation>Pharmacy Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Rijo, Joao" sort="Rijo, Joao" uniqKey="Rijo J" first="João" last="Rijo">João Rijo</name>
<affiliation>
<nlm:affiliation>Pharmacy Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Povoa, Pedro" sort="Povoa, Pedro" uniqKey="Povoa P" first="Pedro" last="Povoa">Pedro Povoa</name>
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<nlm:affiliation>Polyvalent Intensive Care Unit, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Pais Martins, Antonio" sort="Pais Martins, Antonio" uniqKey="Pais Martins A" first="Antonio" last="Pais Martins">Antonio Pais Martins</name>
<affiliation>
<nlm:affiliation>Surgical Intensive Care Unit. Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Carmo, Eduarda" sort="Carmo, Eduarda" uniqKey="Carmo E" first="Eduarda" last="Carmo">Eduarda Carmo</name>
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<nlm:affiliation>Polyvalent Intensive Care Unit. Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Mansinho, Kamal" sort="Mansinho, Kamal" uniqKey="Mansinho K" first="Kamal" last="Mansinho">Kamal Mansinho</name>
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<nlm:affiliation>Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Infecciology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Fonseca, Candida" sort="Fonseca, Candida" uniqKey="Fonseca C" first="Candida" last="Fonseca">Candida Fonseca</name>
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<nlm:affiliation>Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.</nlm:affiliation>
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<affiliation>
<nlm:affiliation>Internal Medicine, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<name sortKey="Campos, Luis" sort="Campos, Luis" uniqKey="Campos L" first="Luis" last="Campos">Luis Campos</name>
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<nlm:affiliation>Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.</nlm:affiliation>
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<nlm:affiliation>Internal Medicine, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Carvalho, Ant Nio" sort="Carvalho, Ant Nio" uniqKey="Carvalho A" first="Ant Nio" last="Carvalho">Ant Nio Carvalho</name>
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<nlm:affiliation>Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Internal Medicine, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Mirco, Ana" sort="Mirco, Ana" uniqKey="Mirco A" first="Ana" last="Mirco">Ana Mirco</name>
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<nlm:affiliation>Social Pharmacy, Universidade de Lisboa Faculdade de Farmácia, Lisbon, Portugal.</nlm:affiliation>
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<affiliation>
<nlm:affiliation>Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<name sortKey="Farinha, Helena" sort="Farinha, Helena" uniqKey="Farinha H" first="Helena" last="Farinha">Helena Farinha</name>
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<nlm:affiliation>Social Pharmacy, Universidade de Lisboa Faculdade de Farmácia, Lisbon, Portugal.</nlm:affiliation>
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<nlm:affiliation>Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
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<affiliation>
<nlm:affiliation>Pharmacy Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<name sortKey="Aldir, Isabel" sort="Aldir, Isabel" uniqKey="Aldir I" first="Isabel" last="Aldir">Isabel Aldir</name>
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<nlm:affiliation>Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Faculdade de Ciências Médicas, Universidade Nova de Lisboa, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
<affiliation>
<nlm:affiliation>Infecciology Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Correia, Jose" sort="Correia, Jose" uniqKey="Correia J" first="José" last="Correia">José Correia</name>
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<nlm:affiliation>Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</nlm:affiliation>
</affiliation>
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<series>
<title level="j">European journal of hospital pharmacy : science and practice</title>
<idno type="ISSN">2047-9956</idno>
<imprint>
<date when="2021" type="published">2021</date>
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<div type="abstract" xml:lang="en">
<p>
<b>OBJECTIVES</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>Real-world data are crucial to further establish the safety profile for REM. HCQ is no longer recommended for the treatment of COVID-19.</p>
</div>
</front>
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<Title>European journal of hospital pharmacy : science and practice</Title>
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<ArticleTitle>A prospective, observational study to evaluate adverse drug reactions in patients with COVID-19 treated with remdesivir or hydroxychloroquine: a preliminary report.</ArticleTitle>
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<Abstract>
<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">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.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
<CopyrightInformation>© European Association of Hospital Pharmacists 2021. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Falcão</LastName>
<ForeName>Fátima</ForeName>
<Initials>F</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0002-2860-061X</Identifier>
<AffiliationInfo>
<Affiliation>Pharmacy, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal mffalcao@chlo.min-saude.pt.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Social Pharmacy, Universidade de Lisboa Faculdade de Farmácia, Lisbon, Portugal.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</Affiliation>
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<Initials>E</Initials>
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<Affiliation>Social Pharmacy, Universidade de Lisboa Faculdade de Farmácia, Lisbon, Portugal.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Pharmacy and Therapeutics Committee, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</Affiliation>
</AffiliationInfo>
<AffiliationInfo>
<Affiliation>Pharmacy Department, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</Affiliation>
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<LastName>Carmo</LastName>
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<Affiliation>Pharmacy Department, Hospital de S. Francisco Xavier, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</Affiliation>
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<Affiliation>Pharmacy Department, Hospital de Egas Moniz, Centro Hospitalar de Lisboa Ocidental EPE, Lisbon, Portugal.</Affiliation>
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<Year>2021</Year>
<Month>01</Month>
<Day>15</Day>
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<Keyword MajorTopicYN="N">COVID-19</Keyword>
<Keyword MajorTopicYN="N">clinical medicine</Keyword>
<Keyword MajorTopicYN="N">drug monitoring</Keyword>
<Keyword MajorTopicYN="N">drug-related side effects and adverse reactions</Keyword>
<Keyword MajorTopicYN="N">hospital</Keyword>
<Keyword MajorTopicYN="N">pharmacy service</Keyword>
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<CoiStatement>Competing interests: None declared.</CoiStatement>
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