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Monitorização Intensiva de Dolutegravir no Centro Hospitalar Lisboa Ocidental E.P.E., Hospital Egas Moniz
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Introdução: A farmacovigilância desempenha um papel fulcral na segurança dos doentes, na melhoria das terapêuticas e no avanço da ciência farmacêutica. A monitorização intensiva incide sobre medicamentos específicos (novos). Dolutegravir, um inibidor da integrase do VIH, é uma opção de tratamento inovadora.
Objectivos: Avaliação do perfil de segurança e possíveis reações adversas associadas à utilização de Dolutegravir, relatados pelos doentes através de um programa de monitorização intensiva, no Centro Hospitalar de Lisboa Ocidental E.P.E., Hospital Egas Moniz.
Métodos: O programa de monitorização intensiva em ambiente hospitalar é baseado num estudo coorte observacional prospetivo não intervencional com aplicação de inquéritos respondidos pelos doentes. O recrutamento dos doentes é realizado no ato de levantamento da medicação, de Tivicay® e Triumeq®, entre 13 Setembro e 13 Novembro 2017. Cumpridos os critérios de inclusão, os doentes são convidados a participar no estudo mediante apresentação do formulário de informação e consentimento informado. Após a aceitação, receberão mensalmente no seu email, por um período de 3 meses um inquérito.
Resultados: Dos 34 doentes recrutados, apenas se obtiveram, até à data, 9 respostas. Serão aqui apresentados os resultados dos doentes já recrutados. Resultados conclusivos serão posteriormente processados e submetidos a avaliação para posterior apresentação e divulgação em publicação científica no formato de artigo científico ou apresentação oral em Reunião Científica Nacional ou Internacional
Conclusões: Devido aos resultados insuficientes, este estudo terá que ser concluído para que se possam tirar conclusões mais sólidas, que terão que ser baseadas numa dimensão amostral maior para o qual é necessário num período de tempo mais alargado. Da análise dos poucos resultados obtidos, e apesar da diminuta dimensão amostral, concluímos que se sobrepõem aos resultados encontrados na literatura, onde o fármaco Dolutegravir é bem tolerado em doentes infetados com VIH, com a presença de baixa frequência de RAMs e de gravidade ligeira.
Introduction: Pharmacovigilance plays a key role in patient safety, in improving therapeutics and evolution of pharmaceutical science. Intensive monitoring provides actual clinical data on (new) specific medications over a period of time. Dolutegravir, an HIV integrase inhibitor, is a relatively new treatment option. Purpose: Assessment of the safety profile and possible adverse drug reactions (ADRs) associated with the use of Dolutegravir, reported by patients through an intensive monitoring program at the West Lisbon Hospital Center E.P.E., Egas Moniz Hospital. Methods: Intensive monitoring program in a hospital environment is based on a non-interventional prospective observational cohort study with surveys answered by patients. Patient recruitment is performed through dispensation at the hospital’s pharmaceutical services of prescriptions for Tivicay® or Triumeq® between September 13th and November 13th 2017. Patients that meet the inclusion criteria are invited to participate in the study by submitting the informed consent form. After acceptance, the subjects will receive a monthly survey in their e-mail for a period of 3 months. Results: Only a total of 9 patients out of the recruited 34 have answered the surveys to this date. We will feature the results of patients who have been recruited. Conclusive results will be further processed and submitted for evaluation for later presentation in scientific publication in paper format or oral presentation at National or International Scientific Meeting. Conclusions: Due to the insufficient results, this study will have to be continued in order to draw more solid conclusions. This will be achieved with a larger sample size, for which is necessary a longer period of time. From the analysis of the few obtained results, and apart from the small sample size, we conclued that it overlaps with results from previous studys where Dolutegravir is well tolerated in HIV-infected patients, with low frequency manifestations of ADRs and of mild severity.
Introduction: Pharmacovigilance plays a key role in patient safety, in improving therapeutics and evolution of pharmaceutical science. Intensive monitoring provides actual clinical data on (new) specific medications over a period of time. Dolutegravir, an HIV integrase inhibitor, is a relatively new treatment option. Purpose: Assessment of the safety profile and possible adverse drug reactions (ADRs) associated with the use of Dolutegravir, reported by patients through an intensive monitoring program at the West Lisbon Hospital Center E.P.E., Egas Moniz Hospital. Methods: Intensive monitoring program in a hospital environment is based on a non-interventional prospective observational cohort study with surveys answered by patients. Patient recruitment is performed through dispensation at the hospital’s pharmaceutical services of prescriptions for Tivicay® or Triumeq® between September 13th and November 13th 2017. Patients that meet the inclusion criteria are invited to participate in the study by submitting the informed consent form. After acceptance, the subjects will receive a monthly survey in their e-mail for a period of 3 months. Results: Only a total of 9 patients out of the recruited 34 have answered the surveys to this date. We will feature the results of patients who have been recruited. Conclusive results will be further processed and submitted for evaluation for later presentation in scientific publication in paper format or oral presentation at National or International Scientific Meeting. Conclusions: Due to the insufficient results, this study will have to be continued in order to draw more solid conclusions. This will be achieved with a larger sample size, for which is necessary a longer period of time. From the analysis of the few obtained results, and apart from the small sample size, we conclued that it overlaps with results from previous studys where Dolutegravir is well tolerated in HIV-infected patients, with low frequency manifestations of ADRs and of mild severity.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2017
Palavras-chave
Farmacovigilância Reação adversa ao medicamento Monitorização intensiva Notificação espontânea Dolutegravir Mestrado Integrado - 2017