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Efeitos adversos da hidroxicloroquina em doentes COVID-19
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Abstract(s)
Introdução: A hidroxicloroquina é um fármaco antimalárico que pertence ao grupo 4-aminoquinolonas. Para além destas propriedades, apresenta características imunomoduladoras e anti-inflamatórias. Os efeitos adversos mais comuns são de cariz gastrointestinal e cardiovascular, neurotoxicidade e também retinopatia. Relativamente às interações medicamentosas, a hidroxicloroquina interfere com vários fármacos, nomeadamente a digoxina, insulina, amiodarona, moxifloxacina, azitromicina, tamoxifeno e praziquantel. Em 2020, com o surgimento da pandemia COVID-19 os investigadores utilizaram medicamentos já existentes com potencial para o tratamento de COVID-19, de entre os quais a hidroxicloroquina, que acabou por ser utilizada off-label. Dos ensaios clínicos conhecidos pode concluirse que a hidroxicloroquina apresenta muitos efeitos adversos que podem colocar em risco a saúde dos doentes infetados com SARS-CoV-2.
Objetivos: O objetivo desta pesquisa foi descrever o perfil de efeitos adversos da hidroxicloroquina em
pacientes com COVID-19 e caracterizar os riscos associados ao uso off-label da hidroxicloroquina.
Métodos: Foi conduzido um estudo observacional, retrospetivo e descritivo, cujo objetivo foi perceber os
efeitos adversos da hidroxicloroquina em doentes COVID-19. Foi elaborada uma pesquisa de artigos
científicos em bases de dados como PubMed® (Medline) e Google Scholar®, tendo em conta os critérios
de inclusão e exclusão. Os dados foram recolhidos da base de dados “Eudravigilance” e, posteriormente,
analisados através de estatística descritiva, com auxílio do software R Studio®.
Resultados: Os resultados apresentam informações acerca da fonte de notificação, sexo do paciente,
reações adversas, casos off-label e a sua evolução, medicamentos avaliados no estudo e mortes avaliadas
no período pré e pós-pandemia. Verifica-se que os profissionais de saúde são quem mais notifica (92%,
n=2223), bem como as mulheres são o sexo que representa a maior percentagem de pacientes notificados
(2020: 64%; 2021: 81%). A análise das faixas etárias permitiu concluir que a dos 18-64 anos apresenta
maior número de pacientes notificados (2020: 49%; 2021: 53%). Relativamente às reações adversas,
confirma-se que as mesmas aumentaram bastante a partir do ano de 2020, devido ao aparecimento da
pandemia, havendo um aumento de 310% das RAM nos anos de pandemia (2020-2021) face aos três anos
em anteriores (2017 a 2019). A utilização off-label da hidroxicloroquina também foi um aspeto importante
a considerar neste estudo, pelo que o tratamento da COVID-19 foi a patologia que maior percentagem
apresentou neste parâmetro (2020: 26% das reações suspeitas de terem sido causadas pela hidroxicloroquina; 78% das reações suspeitas de terem sido causas pela hidroxicloroquina em interação
com outro medicamento. 2021: 8% das reações suspeitas de terem sido causadas pela hidroxicloroquina;
55% das reações suspeitas de terem sido causas pela hidroxicloroquina em interação com outro
medicamento). Ao longo do estudo avaliou-se a evolução dos casos off-label, verificando-se que o risco
de vida e a incapacidade foram crescendo ao longo deste período de pandemia. Por outro lado, comparando antes e depois da COVID-19, os indivíduos que apresentavam outras condições clinicamente
importantes foi um dos aspetos que mais evoluiu (n= 175 para n=1334). Por vezes a hidroxicloroquina foi
utilizada em administração concomitante com outros fármacos, podendo as RAMs serem causadas pela
hidroxicloroquina como principal medicamento suspeito, ou da interação com outras substâncias. Deste modo, os grupos farmacológicos que mais se utilizaram foram os antirretrovirais e alguns antibióticos. Por
fim, também foram avaliadas as mortes associadas à toma de hidroxicloroquina, das quais 67% são descritas em utilização off-label.
Discussão: O número de notificações de reações adversas à hidroxicloroquina aumentou bastante durante a pandemia, sendo os profissionais de saúde quem mais notificou. O potencial de dano aumentou, uma vez que a administração off-label da hidroxicloroquina foi associada a um aumento da incidência e gravidade das reações adversas. Contudo, associada a outros medicamentos, este fármaco pode potenciar determinadas reações adversas, como o prolongamento do intervalo QT, náuseas, tonturas, hipoglicemia, insuficiência cardíaca, entre outras. No que diz respeito aos outcomes, parece ocorrer um aumento do número de mortes associadas à hidroxicloroquina, no entanto a causalidade não está estabelecida para os dados observados.
Conclusão: A hidroxicloroquina apresentou reações adversas variadas nos dados observados, sendo que
pela sua utilização off-label durante a pandemia se demonstrou um aumento da sua incidência. Em relação à COVID-19, inicialmente não existia um tratamento específico, pelo que se efetuaram ensaios clínicos com vários medicamentos, incluído a hidroxicloroquina. Através dos resultados deste estudo, conclui-se que os profissionais de saúde são quem mais notificou e que o sexo feminino é o género que apresenta maior percentagem de pacientes notificados. Sabe-se que a hidroxicloroquina causa efeitos adversos, porém as reações adversas podem não estar associadas diretamente à hidroxicloroquina, pois existem alguns fatores que colocam a sua eficácia em risco, como as comorbilidades e medicamentos concomitantes. A utilização off-label da hidroxicloroquina demonstrou colocar em risco o estado clínico dos indivíduos.
Introduction: Hydroxychloroquine is an antimalarial drug that belongs to the 4-aminoquinolone group. In addition to these properties, it has immunomodulatory and anti-inflammatory characteristics. The most common adverse effects are gastrointestinal and cardiovascular, neurotoxicity and also retinopathy. Regarding drug interactions, hydroxychloroquine interferes with several drugs, namely digoxin, insulin, amiodarone, moxifloxacin, azithromycin, tamoxifen and praziquantel. In 2020, with the emergence of the COVID-19 pandemic, researchers used existing drugs with potential for the treatment of COVID-19, including hydroxychloroquine, which ended up being used off-label. From the known clinical trials it can be concluded that hydroxychloroquine has many adverse effects that can put the health of patients infected with SARS CoV-2 at risk. Objectives: The objective of this research was to describe the adverse effect profile of hydroxychloroquine in patients with COVID-19 and to characterize the risks associated with the off-label use of hydroxychloroquine. Methods: An observational, retrospective and descriptive study was conducted, whose objective was to understand the adverse effects of hydroxychloroquine in COVID-19 patients. A search of scientific articles was carried out in databases such as PubMed® (Medline) and Google Scholar®, taking into account the inclusion and exclusion criteria. Data were collected from the “Eudravigilance” database and, later, analyzed using descriptive statistics, with the aid of the R Studio® software. Results: The results present information about the source of notification, patient gender, adverse reactions, off-label cases and their evolution, drugs evaluated in the study and deaths evaluated in the pre- and post-pandemic period. It appears that health professionals are the ones who report the most (92%, n=2223), as well as women are the sex that represents the highest percentage of reported patients (2020: 64%; 2021: 81%). The analysis of age groups allowed us to conclude that the 18-64 age group has the highest number of reported patients (2020: 49%; 2021: 53%). Regarding adverse reactions, it is confirmed that they increased significantly from 2020 onwards, due to the emergence of the pandemic, with an increase of 310% of ADRs in the pandemic years (2020-2021) compared to the three years in previous years (2017 to 2019). The off-label use of hydroxychloroquine was also an important aspect to consider in this study, so the treatment of COVID-19 was the pathology with the highest percentage in this parameter (2020: 26% of reactions suspected to have been caused by hydroxychloroquine; 78% of reactions suspected to have been caused by hydroxychloroquine interacting with another drug. 2021: 8% of reactions suspected to have been caused by hydroxychloroquine; 55% of reactions suspected to have been caused by hydroxychloroquine interacting with another drug). Throughout the study, the evolution of off-label cases was evaluated, verifying that the risk of life and disability were increasing throughout this pandemic period. On the other hand, comparing before and after COVID-19, individuals who had other clinically important conditions was one of the aspects that evolved the most (n=175 to n=1334). Sometimes hydroxychloroquine was used concomitantly with other drugs, and ADRs may be caused by hydroxychloroquine as the main suspected drug, or from interaction with other substances. Thus, the pharmacological groups that were most used were antiretrovirals and some antibiotics. Finally, deaths associated with the use of hydroxychloroquine were also evaluated, of which 67% are described in offlabel use. Discussion: The number of reports of adverse reactions to hydroxychloroquine increased significantly during the pandemic, with health professionals reporting the most. The potential for harm increased as off-label administration of hydroxychloroquine was associated with an increased incidence and severity of adverse reactions. However, associated with other drugs, this drug may potentiate certain adverse reactions, such as QT interval prolongation, nausea, dizziness, hypoglycemia, heart failure, among others. With regard to outcomes, there seems to be an increase in the number of deaths associated with hydroxychloroquine, however causality has not been established for the observed data. Conclusion: Hydroxychloroquine presented varied adverse reactions in the observed data, and its offlabel use during the pandemic showed an increase in its incidence. In relation to COVID-19, initially there was no specific treatment, so clinical trials were carried out with several drugs, including hydroxychloroquine. Through the results of this study, it is concluded that health professionals are the ones who reported the most and that females are the gender with the highest percentage of reported patients. It is known that hydroxychloroquine causes adverse effects, but adverse reactions may not be directly associated with hydroxychloroquine, as there are some factors that put its effectiveness at risk, such as comorbidities and concomitant medications. The off-label use of hydroxychloroquine has been shown to jeopardize the clinical status of individuals.
Introduction: Hydroxychloroquine is an antimalarial drug that belongs to the 4-aminoquinolone group. In addition to these properties, it has immunomodulatory and anti-inflammatory characteristics. The most common adverse effects are gastrointestinal and cardiovascular, neurotoxicity and also retinopathy. Regarding drug interactions, hydroxychloroquine interferes with several drugs, namely digoxin, insulin, amiodarone, moxifloxacin, azithromycin, tamoxifen and praziquantel. In 2020, with the emergence of the COVID-19 pandemic, researchers used existing drugs with potential for the treatment of COVID-19, including hydroxychloroquine, which ended up being used off-label. From the known clinical trials it can be concluded that hydroxychloroquine has many adverse effects that can put the health of patients infected with SARS CoV-2 at risk. Objectives: The objective of this research was to describe the adverse effect profile of hydroxychloroquine in patients with COVID-19 and to characterize the risks associated with the off-label use of hydroxychloroquine. Methods: An observational, retrospective and descriptive study was conducted, whose objective was to understand the adverse effects of hydroxychloroquine in COVID-19 patients. A search of scientific articles was carried out in databases such as PubMed® (Medline) and Google Scholar®, taking into account the inclusion and exclusion criteria. Data were collected from the “Eudravigilance” database and, later, analyzed using descriptive statistics, with the aid of the R Studio® software. Results: The results present information about the source of notification, patient gender, adverse reactions, off-label cases and their evolution, drugs evaluated in the study and deaths evaluated in the pre- and post-pandemic period. It appears that health professionals are the ones who report the most (92%, n=2223), as well as women are the sex that represents the highest percentage of reported patients (2020: 64%; 2021: 81%). The analysis of age groups allowed us to conclude that the 18-64 age group has the highest number of reported patients (2020: 49%; 2021: 53%). Regarding adverse reactions, it is confirmed that they increased significantly from 2020 onwards, due to the emergence of the pandemic, with an increase of 310% of ADRs in the pandemic years (2020-2021) compared to the three years in previous years (2017 to 2019). The off-label use of hydroxychloroquine was also an important aspect to consider in this study, so the treatment of COVID-19 was the pathology with the highest percentage in this parameter (2020: 26% of reactions suspected to have been caused by hydroxychloroquine; 78% of reactions suspected to have been caused by hydroxychloroquine interacting with another drug. 2021: 8% of reactions suspected to have been caused by hydroxychloroquine; 55% of reactions suspected to have been caused by hydroxychloroquine interacting with another drug). Throughout the study, the evolution of off-label cases was evaluated, verifying that the risk of life and disability were increasing throughout this pandemic period. On the other hand, comparing before and after COVID-19, individuals who had other clinically important conditions was one of the aspects that evolved the most (n=175 to n=1334). Sometimes hydroxychloroquine was used concomitantly with other drugs, and ADRs may be caused by hydroxychloroquine as the main suspected drug, or from interaction with other substances. Thus, the pharmacological groups that were most used were antiretrovirals and some antibiotics. Finally, deaths associated with the use of hydroxychloroquine were also evaluated, of which 67% are described in offlabel use. Discussion: The number of reports of adverse reactions to hydroxychloroquine increased significantly during the pandemic, with health professionals reporting the most. The potential for harm increased as off-label administration of hydroxychloroquine was associated with an increased incidence and severity of adverse reactions. However, associated with other drugs, this drug may potentiate certain adverse reactions, such as QT interval prolongation, nausea, dizziness, hypoglycemia, heart failure, among others. With regard to outcomes, there seems to be an increase in the number of deaths associated with hydroxychloroquine, however causality has not been established for the observed data. Conclusion: Hydroxychloroquine presented varied adverse reactions in the observed data, and its offlabel use during the pandemic showed an increase in its incidence. In relation to COVID-19, initially there was no specific treatment, so clinical trials were carried out with several drugs, including hydroxychloroquine. Through the results of this study, it is concluded that health professionals are the ones who reported the most and that females are the gender with the highest percentage of reported patients. It is known that hydroxychloroquine causes adverse effects, but adverse reactions may not be directly associated with hydroxychloroquine, as there are some factors that put its effectiveness at risk, such as comorbidities and concomitant medications. The off-label use of hydroxychloroquine has been shown to jeopardize the clinical status of individuals.
Description
Keywords
Hidroxicloroquina Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos COVID-19 Toxicidade Hydroxychloroquine Drug-Related Side Effects and Adverse Reactions Toxicity