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Abstract(s)
O presente trabalho foi realizado no âmbito da unidade curricular estágio do Mestrado
Integrado em Ciências Farmacêuticas e encontra-se divido em dois capítulos: o
primeiro capítulo refere-se à caracterização de suspeitas de reações adversas dos
fármacos inibidores da poli (ADP-ribose) polimerase (PARP) utilizados no tratamento
do cancro da mama com base nos dados retirados da EudraVigilance; o segundo
capítulo diz respeito ao relatório de estágio curricular realizado em Farmácia
Comunitária.
O primeiro capítulo referente à componente de investigação intitula-se “Caracterização
do perfil de suspeitas de reações adversas dos fármacos inibidores da poli ADP-ribose
polimerase utilizados no tratamento do cancro da mama: análise da base de dados
EudraVigilance”. A nível global, o cancro da mama é o cancro mais frequentemente
diagnosticado e é a principal causa de morte por cancro nas mulheres. Os inibidores da
PARP emergiram como uma classe terapêutica promissora no tratamento do cancro da
mama. Atualmente, existem dois inibidores da PARP aprovados pela Agência Europeia
do Medicamento (EMA) para o tratamento de doentes com mutações BRCA1/2, com
cancro da mama metastático ou localmente avançado e recetor de fator de crescimento
epidérmico humano tipo 2 (HER2) negativo, o olaparib e o talazoparib. Apesar de
serem uma terapêutica dirigida, existem reações adversas medicamentosas (RAMs)
associadas que devem ser analisadas para garantir a segurança do doente. A base de
dados EudraVigilance oferece uma importante fonte de dados para análise de suspeitas
de RAMs associadas a estes medicamentos. Desta forma, este estudo teve como
objetivo caracterizar o perfil de suspeitas de RAMs dos inibidores da PARP utilizados
no tratamento do cancro da mama, com base nos dados disponíveis na base de dados
EudraVigilance. Foi realizada uma análise retrospetiva dos dados extraídos da
EudraVigilance desde a data de autorização de introdução no mercado dos inibidores
da PARP em estudo, até ao dia 1 de setembro de 2023. As notificações de suspeitas de
RAMs nas quais o olaparib e o talazoparib não foram indicados para o tratamento do
cancro da mama foram excluídas. Na análise estatística, procedeu-se à análise
descritiva das variáveis em estudo através de frequências absolutas e relativas. O teste
do Qui-Quadrado de Pearson foi aplicado para detetar diferenças entre as variáveis e o
Reporting Odds Ratio para analisar a desproporcionalidade das suspeitas de RAMs. No
total foram incluídas no estudo 704 notificações, nas quais predominaram as RAMs
graves. Os grupos System Organ Classes (SOC) mais frequentemente notificados, foram doenças do sistema sanguíneo e linfático, neoplasias, investigações, doenças
gastrointestinais e perturbações gerais. As suspeitas de RAMs neutropenia e
trombocitopenia foram desproporcionalmente superiores para o talazoparib, enquanto
a suspeita de RAM náusea demonstrou ser desproporcionalmente superior para o
olaparib. Estes resultados destacam a importância de monitorizar continuamente a
segurança dos inibidores da PARP. O conhecimento do perfil das RAMs contribui para
a prática clínica e particularmente no que diz respeito à prevenção e gestão das RAMs.
O segundo capítulo aborda as atividades realizadas no decorrer do estágio curricular
em farmácia comunitária, realizado na Farmácia Avenida, no Fundão, entre 7 de
fevereiro e 30 de junho de 2022, sob a orientação da Dra. Cátia Pereira.
This work was carried out as part of the internship curricular unit of the master’s degree in Pharmaceutical Sciences and is divided into two chapters: the first chapter refers to the characterization of suspected adverse reactions of poly (ADP-ribose) polymerase (PARP) inhibitor drugs used in the treatment of breast cancer based on data taken from EudraVigilance; the second chapter refers to the curricular internship report carried out in Community Pharmacy. The first chapter of the research component is entitled " Characterization of the profile of suspected adverse reactions to poly ADP-ribose polymerase inhibitors used in the treatment of breast cancer: analysis of the EudraVigilance database". Breast cancer is the most diagnosed cancer worldwide and the leading cause of cancer death in women. PARP inhibitors have emerged as a promising class of drugs for the treatment of breast cancer. Two PARP inhibitors, olaparib and talazoparib, are currently approved by the European Medicines Agency (EMA) to treat patients with BRCA1/2 mutations, metastatic or locally advanced, human epidermal growth factor receptor type 2 (HER2)-negative breast cancer. Although they are targeted therapies, they have associated adverse drug reactions (ADRs) that need to be analyzed to ensure patient safety. The EudraVigilance database is an important source of data for the analysis of suspected ADRs associated with these medicines. Therefore, the aim of this study was to characterize the profile of suspected ADRs to PARP inhibitors used in the treatment of breast cancer based on the data available in the EudraVigilance database. A retrospective analysis of the data extracted from EudraVigilance was performed from the date of marketing authorization of the PARP inhibitors under study until 1 September 2023. Reports of suspected ADRs in which olaparib and talazoparib were not indicated for the treatment of breast cancer were excluded. Statistical analysis included descriptive analysis of the variables of interest using absolute and relative frequencies, Pearson's chi-square test to detect differences between variables, and reporting odds ratio to analyze the disproportionality of suspected ADRs. A total of 704 ADR reports were included in the study, with serious ADRs being the most common. The most commonly reported System Organ Classes (SOCs) were diseases of the blood and lymph system, neoplasms, investigations, gastrointestinal diseases and general disorders. The suspected ADRs of neutropenia and thrombocytopenia were disproportionately higher for talazoparib, while the suspected ADR of nausea was disproportionately higher for olaparib. These results highlight the importance of continuous safety monitoring of PARP inhibitors. Knowledge of the ADR profile contributes to improve clinical practice, particularly regarding the prevention and management of ADRs. The second chapter describes the activities carried out during the curricular internship in community pharmacy, held at Farmácia Avenida, in Fundão, between 7 February and 30 June, under the guidance of Dr. Cátia Pereira.
This work was carried out as part of the internship curricular unit of the master’s degree in Pharmaceutical Sciences and is divided into two chapters: the first chapter refers to the characterization of suspected adverse reactions of poly (ADP-ribose) polymerase (PARP) inhibitor drugs used in the treatment of breast cancer based on data taken from EudraVigilance; the second chapter refers to the curricular internship report carried out in Community Pharmacy. The first chapter of the research component is entitled " Characterization of the profile of suspected adverse reactions to poly ADP-ribose polymerase inhibitors used in the treatment of breast cancer: analysis of the EudraVigilance database". Breast cancer is the most diagnosed cancer worldwide and the leading cause of cancer death in women. PARP inhibitors have emerged as a promising class of drugs for the treatment of breast cancer. Two PARP inhibitors, olaparib and talazoparib, are currently approved by the European Medicines Agency (EMA) to treat patients with BRCA1/2 mutations, metastatic or locally advanced, human epidermal growth factor receptor type 2 (HER2)-negative breast cancer. Although they are targeted therapies, they have associated adverse drug reactions (ADRs) that need to be analyzed to ensure patient safety. The EudraVigilance database is an important source of data for the analysis of suspected ADRs associated with these medicines. Therefore, the aim of this study was to characterize the profile of suspected ADRs to PARP inhibitors used in the treatment of breast cancer based on the data available in the EudraVigilance database. A retrospective analysis of the data extracted from EudraVigilance was performed from the date of marketing authorization of the PARP inhibitors under study until 1 September 2023. Reports of suspected ADRs in which olaparib and talazoparib were not indicated for the treatment of breast cancer were excluded. Statistical analysis included descriptive analysis of the variables of interest using absolute and relative frequencies, Pearson's chi-square test to detect differences between variables, and reporting odds ratio to analyze the disproportionality of suspected ADRs. A total of 704 ADR reports were included in the study, with serious ADRs being the most common. The most commonly reported System Organ Classes (SOCs) were diseases of the blood and lymph system, neoplasms, investigations, gastrointestinal diseases and general disorders. The suspected ADRs of neutropenia and thrombocytopenia were disproportionately higher for talazoparib, while the suspected ADR of nausea was disproportionately higher for olaparib. These results highlight the importance of continuous safety monitoring of PARP inhibitors. Knowledge of the ADR profile contributes to improve clinical practice, particularly regarding the prevention and management of ADRs. The second chapter describes the activities carried out during the curricular internship in community pharmacy, held at Farmácia Avenida, in Fundão, between 7 February and 30 June, under the guidance of Dr. Cátia Pereira.
Description
Keywords
Cancro da Mama Eudravigilance Farmácia Comunitária Farmacovigilância Inibidores da Parp Reações Adversas a
Medicamentos