Uso off-label da ivermectina na COVID-19
Off-label medication is one whose indication differs from what is stated in the package insert, being used for a purpose other than that authorized by the country's regulatory body, in relation to age, dose, therapeutic indication, or route of administration. This practice of repositioning medi...
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Uso Off-label da Ivermectina na COVID-19, Medicamento Reposicionado, Medicamento Off-label, Revisão. |
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Uso Off-label da Ivermectina na COVID-19, Medicamento Reposicionado, Medicamento Off-label, Revisão. Araújo, Ana Paula França de Uso off-label da ivermectina na COVID-19 |
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Off-label medication is one whose indication differs from what is stated in the package insert, being used for a purpose other than that authorized by the country's regulatory body, in relation to age, dose, therapeutic indication, or route of administration. This practice of repositioning medications has been common for the treatment of COVID-19, as it is caused by a new virus, which is still being studied and understood by the scientific community, and there is no specific medication for its treatment, apart from vaccines. The aim of this study is to address the off-label use of Ivermectin in the treatment of COVID-19, its implications for therapy and the role of the pharmacist in relation to repositioned drugs, given the great politicization of its use in the pandemic caused by SarsCov- two. From a brief descriptive literature review, a search was performed in the electronic databases of Science Direct and Scientific Electronic Library Online (SciELO) and Academics Google Search, with the search engine that included “Ivermectin in COVID-19”, whose approaches complemented the discussion. Most studies available in the literature are supported by in vitro therapeutic responses and the recommendation for use in humans has been based on the findings of these studies. In vitro study performed by CALY, L. et al., (2020), Ivermectin showed a 93% reduction of the genetic material of SARS-CoV-2 in 24 hours and a 99.8% reduction after 48 hours. However, in silico studies indicated that plasma concentrations of Ivermectin did not reach the effective concentration (EC 50%). A recent study published in the Journal of the American Medical Association (JAMA) evaluated whether Ivermectin would improve symptoms in people with COVID-19 when used in the first days of infection, and the result was that the drug made no difference when used early. Despite the positive in vitro results, it is not yet possible to know whether the efficacy will be repeated in use in humans, remaining as unproven for COVID-19. Considering that research on the off-label use of Ivermectin in COVID-19 that occurs with medical prescription or by self-medication were mostly ineffective, this study aims to contribute to the importance of the pharmacist in therapy, clarifying to patients who question at all times about the influence of the aforementioned drug in the pathological process of COVID-19, clinical trials are still needed for an unequivocal evaluation of its clinical effectiveness, while respecting the medical autonomy regarding the prescription and consent of the patient. It should also inform that its prior license for other pathologies (off-label use), must be preceded by randomized, controlled and consolidated clinical trials, in accordance with research ethics, so that this drug is eligible for the treatment of COVID-19. |
| author2 |
Aguiar, Maria Célia Ribeiro Dantas de. |
| author_facet |
Aguiar, Maria Célia Ribeiro Dantas de. Araújo, Ana Paula França de |
| format |
bachelorThesis |
| author |
Araújo, Ana Paula França de |
| author_sort |
Araújo, Ana Paula França de |
| title |
Uso off-label da ivermectina na COVID-19 |
| title_short |
Uso off-label da ivermectina na COVID-19 |
| title_full |
Uso off-label da ivermectina na COVID-19 |
| title_fullStr |
Uso off-label da ivermectina na COVID-19 |
| title_full_unstemmed |
Uso off-label da ivermectina na COVID-19 |
| title_sort |
uso off-label da ivermectina na covid-19 |
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Universidade Federal do Rio Grande do Norte |
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2021 |
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https://repositorio.ufrn.br/handle/123456789/33353 |
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AT araujoanapaulafrancade usoofflabeldaivermectinanacovid19 |
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1773962384343302144 |
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ri-123456789-333532021-09-28T16:27:23Z Uso off-label da ivermectina na COVID-19 Araújo, Ana Paula França de Aguiar, Maria Célia Ribeiro Dantas de. Silva, Júlio César Mendes e Silva, Andreza Kelly Fernandes da Uso Off-label da Ivermectina na COVID-19, Medicamento Reposicionado, Medicamento Off-label, Revisão. Off-label medication is one whose indication differs from what is stated in the package insert, being used for a purpose other than that authorized by the country's regulatory body, in relation to age, dose, therapeutic indication, or route of administration. This practice of repositioning medications has been common for the treatment of COVID-19, as it is caused by a new virus, which is still being studied and understood by the scientific community, and there is no specific medication for its treatment, apart from vaccines. The aim of this study is to address the off-label use of Ivermectin in the treatment of COVID-19, its implications for therapy and the role of the pharmacist in relation to repositioned drugs, given the great politicization of its use in the pandemic caused by SarsCov- two. From a brief descriptive literature review, a search was performed in the electronic databases of Science Direct and Scientific Electronic Library Online (SciELO) and Academics Google Search, with the search engine that included “Ivermectin in COVID-19”, whose approaches complemented the discussion. Most studies available in the literature are supported by in vitro therapeutic responses and the recommendation for use in humans has been based on the findings of these studies. In vitro study performed by CALY, L. et al., (2020), Ivermectin showed a 93% reduction of the genetic material of SARS-CoV-2 in 24 hours and a 99.8% reduction after 48 hours. However, in silico studies indicated that plasma concentrations of Ivermectin did not reach the effective concentration (EC 50%). A recent study published in the Journal of the American Medical Association (JAMA) evaluated whether Ivermectin would improve symptoms in people with COVID-19 when used in the first days of infection, and the result was that the drug made no difference when used early. Despite the positive in vitro results, it is not yet possible to know whether the efficacy will be repeated in use in humans, remaining as unproven for COVID-19. Considering that research on the off-label use of Ivermectin in COVID-19 that occurs with medical prescription or by self-medication were mostly ineffective, this study aims to contribute to the importance of the pharmacist in therapy, clarifying to patients who question at all times about the influence of the aforementioned drug in the pathological process of COVID-19, clinical trials are still needed for an unequivocal evaluation of its clinical effectiveness, while respecting the medical autonomy regarding the prescription and consent of the patient. It should also inform that its prior license for other pathologies (off-label use), must be preceded by randomized, controlled and consolidated clinical trials, in accordance with research ethics, so that this drug is eligible for the treatment of COVID-19. Medicamento off-label é aquele cuja indicação diverge do que consta na bula, sendo utilizado para uma finalidade diferente daquela autorizada pelo órgão regulatório do país, em relação à idade, dose, indicação terapêutica, ou à via de administração. Essa prática de reposicionamento de medicamentos tem sido comum para o tratamento de COVID-19, por ser causada por um vírus novo, que ainda está sendo estudado e compreendido pela comunidade científica, não havendo um medicamento específico para o seu tratamento, afora as vacinas. O objetivo do presente estudo consiste em abordar o uso off -label da Ivermectina no tratamento de COVID-19, suas implicações na terapêutica e o papel do farmacêutico frente aos medicamentos reposicionados, haja vista a grande politização do seu emprego na pandemia provocada pelo SarsCov-2. A partir de uma breve revisão de literatura descritiva, realizou-se uma busca nas bases de dados eletrônicas nas bases de dados eletrônicas do Science Direct e Scientific Electronic Library Online (SciELO) e PubMed, e consistiu em analisar criticamente publicações sobre o uso off-label de Ivermectina na pandemia da COVID-19, através do mecanismo de busca “Ivermectina na COVID-19”; “Medicamento off-label” e “Ivermectina na COVID-19”, cujas abordagens complementaram a discussão. A maioria dos estudos disponíveis na literatura respalda-se em respostas terapêuticas in vitro e a recomendação para uso em humanos tem-se baseado nos achados desses estudos. Estudo in vitro realizado por CALY, L. et al., (2020), a Ivermectina mostrou reduzir 93% do material genético do SARS-CoV-2 em 24 horas e uma redução de 99,8% após 48 horas. No entanto, estudos in sílico, indicaram que as concentrações plasmáticas de Ivermectina não alcançaram a concentração efetiva (CE 50%). Em recente estudo publicado na Revista Científica Journal of the American Medical Association (JAMA) avaliou se a Ivermectina resultaria na melhora dos sintomas das pessoas com COVID-19 quando usada nos primeiros dias de infecção, e o resultado foi de que o fármaco não fez diferença quando usado precocemente. Apesar dos resultados positivos in vitro, ainda não é possível saber se a eficácia se repetirá no uso em humanos, permanecendo como não comprovado para a COVID-19. Considerando que as pesquisas acerca do uso off-label da Ivermectina na COVID-19 ocorre com prescrição médica ou por automedicação, em sua maioria foram ineficazes, este estudo visa contribuir, para a importância do farmacêutico na terapêutica, esclarecendo aos pacientes, que questionam a todo instante sobre a influência do referido fármaco no processo patológico da COVID-19 que ainda são necessários ensaios clínicos para avaliação inequívoca da sua efetividade clínica, embora respeitando a autonomia médica quanto a prescrição e anuência do paciente. Também deve informar que sua licença prévia para outras patologias (uso off-label), devem ser precedidas de ensaios clínicos randomizados, controlados e consolidados, nos termos da ética em pesquisa, para que esse medicamento seja elegível no tratamento da COVID-19. 2021-09-10T18:48:39Z 2021-09-10T18:48:39Z 2021-08-24 bachelorThesis ARAÚJO, Ana Paula França de. Uso off-label da ivermectina na COVID-19. Trabalho de conclusão de curso (Graduação em Farmácia) - Departamento de Farmácia, Universidade Federal do Rio Grande do Norte, Natal, 2021. https://repositorio.ufrn.br/handle/123456789/33353 pt_BR Attribution-NonCommercial-NoDerivs 3.0 Brazil http://creativecommons.org/licenses/by-nc-nd/3.0/br/ application/pdf Universidade Federal do Rio Grande do Norte Brasil UFRN Farmácia Departamento de Farmácia |