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Dried Blood Spot (DBS) as a useful tool to improve clozapine, aripiprazole and paliperidone treatment: From adherence to efficiency
Análisis de sangre seca (Dried Blood Spot [DBS]) como herramienta útil para mejorar el tratamiento con clozapina, aripiprazol y paliperidona: de la adherencia a la eficacia
Miguel Bernardoa, Gisela Mezquidab, Paula Ferréc, Bibiana Cabreraa, Mercè Torrac, Ana Maria Lizanac, Mercè Brunetd,
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mbrunet@clinic.cat

Corresponding author.
a Barcelona Clinic Schizophrenia Unit, Hospital Clinic of Barcelona, Neuroscience Institute, Department of Medicine, University of Barcelona, Biomedical Research Networking Center for Mental Health Network (CIBERSAM), August Pi I Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
b Barcelona Clinic Schizophrenia Unit, Hospital Clinic of Barcelona, Neuroscience Institute; Department of Basic Clinal Practice, Pharmacology Unit, University of Barcelona, Biomedical Research Networking Center for Mental Health Network (CIBERSAM), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
c Pharmacology and Toxicology Laboratoy, SBGM, Hospital Clínic of Barcelona, August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Barcelona, Spain
d Pharmacology and Toxicology Laboratory, SBGM, Hospital Clínic of Barcelona, Biomedical Research Networking Center in Hepatic and Digestive Diseases (CIBEREHD), August Pi i Sunyer Biomedical Research Institute (IDIBAPS), University of Barcelona, Barcelona, Spain
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Abstract
Introduction

Therapeutic Drug Monitoring (TDM) of antipsychotics in schizophrenia is a powerful tool that allows tailoring the treatment in an individualized approach. Our goals are to develop and validate a Dried Blood Spot (DBS) method for monitoring some commonly used antipsychotics (aripiprazole, clozapine, and paliperidone) and to evaluate its usefulness as a compliance biomarker, as well as in drug-dose adjustment to personalize the antipsychotic treatment to improve its efficacy and safety.

Methods

31 first-psychotic episode (FEP) and schizophrenia patients were included; 5 refer to naïve FEP who started antipsychotic treatment; 26, to patients with more than one episode and under antipsychotic treatment: aripiprazole (7 cases), clozapine (17), paliperidone (11). For DBS sample collection, 25μl of capillary blood were placed in the spot of a FTA™DMPK-C-card. After completely dryness, antipsychotics were extracted and analyzed by a validated UHPLC-MS/MS-method. DBS antipsychotic results were compared with those obtained in venous blood/plasma.

Results

Aripiprazole, paliperidone and clozapine showed from good to excellent correlations between concentrations in venous blood and DBS capillary blood (r2, from 0.500 to 0.721). The correlation between conventional plasma and DBS concentrations for paliperidone, aripiprazole, clozapine, and their metabolites were moderate, suggesting that optimal drug target concentrations should be established for DBS.

Conclusions

In this study, for aripiprazole, dehydroaripiprazole, paliperidone, clozapine and desmethylclozapine, DBS has provided good analytical performance for TDM. Thus, DBS sampling can offer a great alternative over conventional sampling for plasma measurement. The assay provides good analytical performances for TDM and clinical research applicability, suggesting that DBS is a promising clinical application in TDM in psychiatry.

Keywords:
Dried Blood Spot (DBS)
Therapeutic drug monitoring (TDM)
Schizophrenia
Adherence
Antipsychotic
Resumen
Introducción

La monitorización terapéutica de medicamentos (Therapeutic Drug Monitoring [TDM]) de los antipsicóticos en la esquizofrenia es una potente herramienta que permite adaptar el tratamiento de forma individualizada y personalizada. Los objetivos del presente estudio son desarrollar y validar un método de análisis en sangre seca (Dried Blood Spot [DBS]) para la monitorización de algunos antipsicóticos de uso común (aripiprazol, clozapina y paliperidona) y evaluar su utilidad como biomarcador de cumplimiento y adherencia terapéutica, así como en el ajuste de la dosis del fármaco para personalizar el tratamiento antipsicótico para mejorar su eficacia y su seguridad.

Metodología

Se incluyeron 31 pacientes con un primer episodio psicótico (PEP) o un diagnóstico de esquizofrenia; 5 eran PEP que iniciaron tratamiento antipsicótico, y 26 eran pacientes con más de un episodio y que seguían tratamiento con antipsicóticos: aripiprazol (7 casos), clozapina (17), paliperidona (11). Para la recogida de muestras de DBS se colocaron 25μl de sangre capilar en el punto de una tarjeta FTATMDMPK-C. Tras secarse completamente, se extrajeron los antipsicóticos y se analizaron mediante un método UHPLC-MS/MS validado. Los resultados de los antipsicóticos según la DBS se compararon con los obtenidos en sangre venosa/plasma.

Resultados

El aripiprazol, la paliperidona y la clozapina mostraron de buenas a excelentes correlaciones entre las concentraciones en sangre venosa y en sangre capilar del DBS (r2, de 0,500 a 0,721). La correlación entre las concentraciones plasmáticas convencionales y las del DBS para la paliperidona, el aripiprazol, la clozapina y sus metabolitos fue moderada, lo que sugiere que se deberían definir y establecer concentraciones óptimas del fármaco para el DBS.

Conclusiones

En este estudio, para el aripiprazol, el dehidroaripiprazol, la paliperidona, la clozapina y la desmetilclozapina, el DBS ha proporcionado un buen rendimiento analítico para la monitorización de estos medicamentos. Por lo tanto, los análisis realizados con DBS pueden ofrecer una gran alternativa sobre los análisis convencionales para la medición del plasma. Los resultados sugieren un buen rendimiento analítico para la TDM y su aplicabilidad en la investigación clínica, lo que sugiere que el DBS tiene una aplicación clínica prometedora en la monitorización terapéutica en psiquiatría.

Palabras clave:
Análisis de sangre seca (Dried Blood Spot [DBS])
Monitorización terapéutica de medicamentos
Esquizofrenia
Adherencia
Antipsicótico

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