Patrones de tratamiento farmacológico para el episodio maníaco en la práctica clínica. Resultados de la muestra española en el estudio EMBLEM / Patterns of drug treatment for manic episode in the clinical practice. Outcomes of the Spanish sample in the EMBLEM Study

Introducción. Aunque el tratamiento de la manía ha sido estudiado profusamente en ensayos clínicos aleatorizados, existen pocos datos respecto al manejo real de estos pacientes en términos clínicos, funcionales y económicos en la práctica psiquiátrica en España. Objetivo. Determinar, a través de la muestra española de pacientes bipolares en fase maníaca o mixta del estudio paneuropeo EMBLEM, los patrones de prescripción en España. Método. El estudio EMBLEM reclutó a 3.681 pacientes, 312 de los cuales (8.47 %) fueron incluidos en España. Los pacientes tenían que ser adultos con diagnóstico de trastorno bipolar que iniciaran tratamiento para una fase maníaca. Se les evaluó con las versiones españolas de escalas para la gravedad (Escala de Young, CGI-BP, Escala de Hamilton) y para la funcionalidad (LCM, SLICE of LIFE). Se recogió información sobre variables farmacológicas y de adherencia al tratamiento. Resultados. Antes de entrar en el estudio el 42% de los pacientes recibía politerapia, el 35% estaba en monoterapia y el 23% no tomaba ninguna medicación. Un 40% de los pacientes incumplía total o parcialmente el tratamiento prescrito. Durante la fase inicial del estudio el manejo agudo de la manía fue a expensas, como monoterapia, de dosis medias diarias de: olanzapina, 25 mg; risperidona, 6,6 mg; haloperidol, 9,5 mg; lamotrigina, 165 mg; valproato, 938,5 mg, y litio, 909 mg, mientras que cuando fueron empleados en combinación las dosis fueron: olanzapina, 22,1 mg; risperidona, 7,3 mg; haloperidol, 12,3 mg; lamotrigina, 175,1 mg; valproato, 1.038,4 mg, y litio, 1.012,6 mg. De los pacientes que al inicio del estudio estaban en monoterapia, el 51% fueron tratados con un solo fármaco y un 48% recibió tratamiento combinado. De entre los pacientes que iniciaron el estudio recibiendo tratamiento combinado, el 94 % continuo recibiendo tratamiento combinado. La gran mayoría de los pacientes (92%) mejoraron al término del estudio. En el caso de los pacientes hospitalizados, los cuales conformaron el 88% de la muestra, el tiempo medio hasta el alta del hospital fue de 24 días. Conclusiones. El tratamiento de la manía en España se sustenta fundamentalmente en tratamientos combinados, hospitalización y dosis de fármacos antimaníacos generalmente algo superiores a las recomendadas en las fichas técnicas, indicando que la realidad clínica es más compleja de lo que indican los ensayos clínicos realizados en condiciones experimentales

Introduction. Although treatment for mania has been studied extensively in randomized clinical trials, there are few data that address how these patients are truly managed in clinical, functional, and economic terms in the psychiatric practice in Spain. Objective. To determine prescribing patterns in Spain on the basis of the Spanish sample of bipolar patients in manic or mixed phase included as part of the pan-European EMBLEM Study. Method. The EMBLEM Study recruited 3,681 patients, 312 of whom (8.47%) were included in Spain. Patients had to be adults with a diagnosis of bipolar disorder who were initiating treatment for a manic phase. They underwent evaluation using the Spanish versions of scales that measure severity of mania (the Young Mania Rating Scale, CGI-BP and the Hamilton Scale) and functional level (LCM, SLICE of LIFE). Information was collected regarding drug and treatment adherence variables. Results. Prior to being admitted into the study, 42% of the patients were receiving polytherapy, 35% were on monotherapy, and 23% were not taking any medication whatsoever. Forty percent of the patients presented partial or total non-compliance with the treatment prescribed. During the first stage of the study, in the case of single-drug treatment, acute management for mania consisted of mean daily doses of 25 mg of olanzapine, 6.6 mg of risperidone, 9.5 mg of haloperidol, 165 mg of lamotrigine, 938.5 mg of valproate, and 909 mg of lithium, whereas when combined therapy was used, the following doses were used: olanzapine, 22.1 mg; risperidone, 7.3 mg; haloperidol, 12.3 mg; lamotrigine, 175.1 mg; valproate, 1,038.4 mg, and lithium, 1012.6 mg. Of those patients who were on monotherapy at the beginning of the study 51% were treated with a single drug, whereas 48 % were receiving polytherapy. Among the participants who were receiving combined treatment when they began the study, almost all of them, 94 %, were prescribed combined treatment. In the case of the hospitalized patients who made up 88% of the sample, the vast majority, 92%, had improved by the time the study was completed. Mean time to release from hospital was 24 days. Discussion. In Spain, treatment for mania is essentially based on combined treatments, hospitalization, and anti-mania drugs that are prescribed at somewhat higher doses than those recommended in the corresponding prescribing information documents, which indicates that the clinical reality of this entity is far more complex than clinical trials conducted in experimental conditions suggest

Patterns of drug treatment for manic episode in the clinical practice. Outcomes of the Spanish sample in the EMBLEM Study.

INTRODUCTION: Although treatment for mania has been studied extensively in randomized clinical trials, there are few data that address how these patients are truly managed in clinical, functional, and economic terms in the psychiatric practice in Spain. OBJECTIVE: To determine prescribing patterns in Spain on the basis of the Spanish sample of bipolar patients in manic or mixed phase included as part of the pan-European EMBLEM Study. METHOD: The EMBLEM Study recruited 3,681 patients, 312 of whom (8.47%) were included in Spain. Patients had to be adults with a diagnosis of bipolar disorder who were initiating treatment for a manic phase. They underwent evaluation using the Spanish versions of scales that measure severity of mania (the Young Mania Rating Scale, CGI-BP and the Hamilton Scale) and functional level (LCM, SLICE of LIFE). Information was collected regarding drug and treatment adherence variables. RESULTS: Prior to being admitted into the study, 42% of the patients were receiving polytherapy, 35% were on monotherapy, and 23% were not taking any medication whatsoever. Forty percent of the patients presented partial or total non-compliance with the treatment prescribed. During the first stage of the study, in the case of single-drug treatment, acute management for mania consisted of mean daily doses of 25 mg of olanzapine, 6.6 mg of risperidone, 9.5 mg of haloperidol, 165 mg of lamotrigine, 938.5 mg of valproate, and 909 mg of lithium, whereas when combined therapy was used, the following doses were used: olanzapine, 22.1 mg; risperidone, 7.3 mg; haloperidol, 12.3 mg; lamotrigine, 1,75.1 mg; valproate, 1,038.4 mg, and lithium, 1012.6 mg. Of those patients who were on monotherapy at the beginning of the study 51% were treated with a single drug, whereas 48% were receiving polytherapy. Among the participants who were receiving combined treatment when they began the study, almost all of them, 94%, were prescribed combined treatment. In the case of the hospitalized patients who made up 88% of the sample, the vast majority, 92%, had improved by the time the study was completed. Mean time to release from hospital was 24 days. DISCUSSION: In Spain, treatment for mania is essentially based on combined treatments, hospitalization, and antimania drugs that are prescribed at somewhat higher doses than those recommended in the corresponding prescribing information documents, which indicates that the clinical reality of this entity is far more complex than clinical trials conducted in experimental conditions suggest.

Riesgo preconcepcional en mujeres de edad fértil / Preconcepcional risk in women of fertile age

Se realizó un estudio sobre riesgo preconcepcional en el año 1989 en mujeres de edad fértil en cada uno de los 40 consultorios del médico y la enfermera de la familia del policlínico área 5 de Cienfuegos con vistas a conocer dentro de su universo de trabajo el número de mujeres comprendidas entre 15 y 49 años en su situación actual referente a su morbilidad y factores de riesgo que pudieran modificar el desarrollo adecuado en su embarazo. Se pudo conocer que existe un control significativo del riesgo preconcepcional, así como preferencia elevada de la utilización de los DIU en relación a otros métodos. El 15 porciento de las mujeres presentan enfermedades crónicas no trasmisibles. Los factores de riesgo de algún modo afectan el 50 porciento de las mujeres en edad fértil. Existe un trabajo del médico y la enfermera dirigido a disminuir el incremento del riesgo para concebir un embarazo adecuado (AU)

Riesgo preconcepcional en mujeres de edad fértil / Preconcepcional risk in women of fertile age

Se realizó un estudio sobre riesgo preconcepcional en el año 1989 en mujeres de edad fértil en cada uno de los 40 consultorios del médico y la enfermera de la familia del policlínico área 5 de Cienfuegos con vistas a conocer dentro de su universo de trabajo el número de mujeres comprendidas entre 15 y 49 años en su situación actual referente a su morbilidad y factores de riesgo que pudieran modificar el desarrollo adecuado en su embarazo. Se pudo conocer que existe un control significativo del riesgo preconcepcional, así como preferencia elevada de la utilización de los DIU en relación a otros métodos. El 15 porciento de las mujeres presentan enfermedades crónicas no trasmisibles. Los factores de riesgo de algún modo afectan el 50 porciento de las mujeres en edad fértil. Existe un trabajo del médico y la enfermera dirigido a disminuir el incremento del riesgo para concebir un embarazo adecuado