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Monitorização terapêutica das concentrações sérias de clozapina em doentes psiquiátricos
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Orientador(es)
Resumo(s)
A monitorização terapêutica (TDM) em psiquiatria é extremamente importante na minimização do impacto que a variabilidade interindividual pode ter na efetividade terapêutica, reduzindo também o potencial de Reações Adversas Medicamentosas (RAM). A Clozapina é um antipsicótico ‘atípico’ extensamente utilizado, constituindo a referência no tratamento da esquizofrenia refratária.
As concentrações séricas de CLZ apresentam alta correlação com os outcomes terapêuticos. Segundo as guidelines europeias de consenso para a TDM em neuropsicofármacos, o intervalo terapêutico para a CLZ é de 350-600 ng/ml.
Este estudo pretende avaliar os níveis séricos de CLZ em doentes psiquiátricos seguidos no Hospital Beatriz Ângelo, a existência de potenciais interações, a ocorrência de RAM e duração do internamento.
Este é um estudo observacional retrospetivo que engloba doentes psiquiátricos internados e/ou em ambulatório entre 2012 e 2022.
Os dados foram recolhidos do processo clínico eletrónico, tendo sido obtidos os seguintes parâmetros: sexo, idade, regime assistencial, diagnóstico, dose total diária, concentrações séricas, interações, RAM e duração do internamento.
A análise estatística foi realizada em PythonTM 3.12.0 e Microsoft Excel 2019.
Foram incluídos 189 doentes, a maioria do sexo masculino (58%). A mediana de idade da amostra foi de 42 anos (16-84), em que 57% se encontravam em regime de ambulatório. O diagnóstico mais frequente foi esquizofrenia (50%).
Observaram-se 701 doseamentos de CLZ. Apenas 20% estavam dentro do intervalo recomendado (mediana 247 ng/ml, 3 -2511), 61% apresentavam níveis infraterapêuticos e 19% supraterapêuticos.
Não houve correlação significativa entre a dose total diária e os níveis sanguíneos, Pearson(r): 0,36, 0,10 e 0,04 respetivamente para os intervalos infra, normal e supraterapêutico.
Verificou-se que 32,3% doentes tinham prescrito pelo menos um fármaco com potencial risco de ‘interação X’.
Verificou-se a ocorrência de RAM em 12,2% dos doentes.
Apesar da importância de manter os níveis adequados de CLZ, a maioria dos doentes apresenta níveis séricos fora do intervalo recomendado. Os farmacêuticos devem monitorizar os valores séricos de CLZ e recomendar ajustes de dose, a fim de aumentar a efetividade e promover a segurança. No âmbito deste estudo projetou-se o desenvolvimento de uma WEB-APP para farmacocinética com CLZ, com base num modelo de machine learning.
Therapeutic monitoring (TDM) in psychiatry is extremely important to minimizing the impact that inter-individual variability can have on therapeutic effectiveness, also reducing the potential Adverse Drug Reactions (ADR). Clozapine is a widely used ‘atypical’ antipsychotic, constituting reference in treatment of refractory schizophrenia. CLZ serum concentrations show a high correlation with therapeutic outcomes. According to the European consensus guidelines for TDM in neuropsychopharmacology, the therapeutic range for CLZ is 350-600 ng/ml. This study aims to evaluate serum levels of CLZ in psychiatric patients followed at Hospital Beatriz Ângelo, the existence of potential interactions, the occurrence of ADRs and length of stay. This is a retrospective observational study that includes psychiatric patients hospitalized and/or outpatients between 2012 and 2022. Data were collected from the electronic clinical process, and the following parameters obtained: sex, age, care regime, diagnosis, total daily dose, serum concentrations, interactions, ADR and duration of hospitalization. Statistical analysis was performed in PythonTM 3.12.0 and Microsoft Excel 2019. 189 patients were included, the majority were male (58%). The median age of the sample was 42 years (16-84), of which 57% were on an outpatient basis. The most frequent diagnosis was schizophrenia (50%). 701 CLZ measurements were observed. Only 20% were within the recommended range (median 247 ng/ml, 3 -2511), 61% had infratherapeutic levels and 19% supratherapeutic. There was no significant correlation between the total daily dose and blood levels, Pearson(r): 0.36, 0,10 and 0,04 respectively for the infra, normal and supratherapeutic ranges. ADR occurred in 12.2% of patients. Despite the importance of maintaining adequate CLZ levels, most psychiatric patients have serum levels outside the recommended range. Pharmacists should monitor CLZ serum values and recommend dose adjustments to increase effectiveness and promote safety. Within the scope of this study, the development of a WEB-APP for pharmacokinetics with CLZ was planned, based on a machine learning model.
Therapeutic monitoring (TDM) in psychiatry is extremely important to minimizing the impact that inter-individual variability can have on therapeutic effectiveness, also reducing the potential Adverse Drug Reactions (ADR). Clozapine is a widely used ‘atypical’ antipsychotic, constituting reference in treatment of refractory schizophrenia. CLZ serum concentrations show a high correlation with therapeutic outcomes. According to the European consensus guidelines for TDM in neuropsychopharmacology, the therapeutic range for CLZ is 350-600 ng/ml. This study aims to evaluate serum levels of CLZ in psychiatric patients followed at Hospital Beatriz Ângelo, the existence of potential interactions, the occurrence of ADRs and length of stay. This is a retrospective observational study that includes psychiatric patients hospitalized and/or outpatients between 2012 and 2022. Data were collected from the electronic clinical process, and the following parameters obtained: sex, age, care regime, diagnosis, total daily dose, serum concentrations, interactions, ADR and duration of hospitalization. Statistical analysis was performed in PythonTM 3.12.0 and Microsoft Excel 2019. 189 patients were included, the majority were male (58%). The median age of the sample was 42 years (16-84), of which 57% were on an outpatient basis. The most frequent diagnosis was schizophrenia (50%). 701 CLZ measurements were observed. Only 20% were within the recommended range (median 247 ng/ml, 3 -2511), 61% had infratherapeutic levels and 19% supratherapeutic. There was no significant correlation between the total daily dose and blood levels, Pearson(r): 0.36, 0,10 and 0,04 respectively for the infra, normal and supratherapeutic ranges. ADR occurred in 12.2% of patients. Despite the importance of maintaining adequate CLZ levels, most psychiatric patients have serum levels outside the recommended range. Pharmacists should monitor CLZ serum values and recommend dose adjustments to increase effectiveness and promote safety. Within the scope of this study, the development of a WEB-APP for pharmacokinetics with CLZ was planned, based on a machine learning model.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2023, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Antipsicóticos Clozapina Monitorização terapêutica de medicamentos Doseamentos e níveis séricos Mestrado Integrado - 2023