Estudio comparativo del uso de fármacos antiepilépticos durante el embarazo en un periodo de 12 años. Eficacia de los nuevos fármacos lamotrigina, levetiracetam y oxacarbamacepina / Comparative study of antiepileptic drug use during pregnancy over a period of 12 years in Spain. Efficacy of the newer antiepileptic drugs lamotrigine, levetiracetam, and oxcarbazepine

Introducción: El patrón de uso de fármacos antiepilépticos (FAE) durante el embarazo difiere entre países y está cambiando. Se desconoce en qué medida ello afecta a la población española. La eficacia de los nuevos fármacos en el control de las crisis es motivo de preocupación y puede haber cambiado a lo largo de los años debido a un mejor conocimiento de su uso durante el embarazo. Con el objetivo de analizar estos 2 aspectos reportamos los resultados del registro EURAP España durante un periodo de 12 años. Material y métodos: Tras el consentimiento informado, las pacientes son incluidas en el registro y evaluadas al inicio del embarazo, al final del segundo y tercer trimestres, después del parto y al año del nacimiento. Para los objetivos de este estudio hemos analizado: FAE, tipo de epilepsia, frecuencia de crisis por trimestres y a lo largo del embarazo, porcentaje de pacientes libres de crisis, y frecuencia de malformaciones congénitas mayores. Hemos comparado estas variables en 2 periodos (junio de 2001-octubre de 2007) y (enero de 2008-mayo de 2015). Resultados: Un total de 304 monoterapias del periodo antiguo se comparan con 127 del periodo nuevo. Observamos un ascenso del uso de levetiracetam (LEV) y un descenso del uso de carbamacepina (CBZ), fenitoína y fenobarbital; un leve descenso del uso de valproato (VPA), y un leve aumento de lamotrigina (LTG) y oxacarbamacepina (OXC). El tipo de epilepsia se mantiene estable para CBZ y VPA, pero cambia para LTG, con menos epilepsias generalizadas tratadas con este fármaco en el periodo nuevo. Ello no se asocia con un cambio significativo de la frecuencia de crisis, pero sí con un mejor control de las crisis de novo en el tercer trimestre. LEV se asocia a niveles de control de crisis similares a los de CBZ y VPA y mejor que con LTG. De las pacientes tratadas con LEV, un 64% tenían una epilepsia generalizada. Conclusiones: El patrón de uso de los diferentes FAE durante el embarazo está cambiando en España, con menos uso de CBZ, fenitoína y fenobarbital y un aumento del uso de LEV. El tipo de epilepsia también cambia, con un porcentaje inferior de pacientes tratadas con LTG para epilepsias generalizadas. LEV controla las crisis de manera similar a los fármacos clásicos y mejor que la LTG (AU)

Introduction: The prescription pattern of antiepileptic drugs (AEDs) during pregnancy is changing but to what extent this is occurring in Spain remains unknown. The efficacy of newer drugs for controlling seizures is a key issue and may have changed over the years as doctors gained familiarity with these drugs during pregnancy. To assess these 2 topics, we report the results from the Spanish EURAP register gathered over a 12-year period. Material and methods: After signing informed consent forms, patients were included in the register and evaluated at onset of pregnancy, at the end of the second and third trimesters, after delivery, and one year after delivery. For the purposes of this study, we analysed AEDs, type of epilepsy, seizure frequency per trimester and throughout pregnancy, percentage of seizure-free pregnancies, and frequency of congenital malformations. We then compared data from 2 periods (June 2001-October 2007) and (January 2008-May 2015). Results: We compared 304 monotherapies from the older period to 127 from the more recent one. There was a clear increase in the use of levetiracetam (LEV) with declining use of carbamazepine (CBZ), phenytoin, and phenobarbital; a slight decline in use of valproate (VPA), and a slight increase in the use of lamotrigine (LTG) and oxcarbazepine (OXC). Epilepsy types treated with CBZ and VPA remained unchanged, whereas fewer cases of generalised epilepsy were treated with LTG in the new period. This trend was not associated with significant changes in seizure frequency, but rather linked to better control over de novo seizures in the third trimester. LEV was similar to CBZ and VPA with regard to levels of seizure control, and more effective than LTG. Generalised epilepsy accounted for 64% of the cases treated with LEV. Conclusions: The prescription pattern of AEDs during pregnancy has changed in Spain, with diminishing use of CBZ, phenytoin, and phenobarbital. Changes also reflect the type of epilepsy, since there is less use of LTG for generalised epilepsy. LEV provides similar seizure control to that of the older AEDs, and it is more effective and better than LTG (AU)

Comparative study of antiepileptic drug use during pregnancy over a period of 12 years in Spain. Efficacy of the newer antiepileptic drugs lamotrigine, levetiracetam, and oxcarbazepine. / Estudio comparativo del uso de fármacos antiepilépticos durante el embarazo en un periodo de 12 años. Eficacia de los nuevos fármacos lamotrigina, levetiracetam y oxacarbamacepina.

INTRODUCTION: The prescription pattern of antiepileptic drugs (AEDs) during pregnancy is changing but to what extent this is occurring in Spain remains unknown. The efficacy of newer drugs for controlling seizures is a key issue and may have changed over the years as doctors gained familiarity with these drugs during pregnancy. To assess these 2 topics, we report the results from the Spanish EURAP register gathered over a 12-year period. MATERIAL AND METHODS: After signing informed consent forms, patients were included in the register and evaluated at onset of pregnancy, at the end of the second and third trimesters, after delivery, and one year after delivery. For the purposes of this study, we analysed AEDs, type of epilepsy, seizure frequency per trimester and throughout pregnancy, percentage of seizure-free pregnancies, and frequency of congenital malformations. We then compared data from 2 periods (June 2001-October 2007) and (January 2008-May 2015) RESULTS: We compared 304 monotherapies from the older period to 127 from the more recent one. There was a clear increase in the use of levetiracetam (LEV) with declining use of carbamazepine (CBZ), phenytoin, and phenobarbital; a slight decline in use of valproate (VPA), and a slight increase in the use of lamotrigine (LTG) and oxcarbazepine (OXC). Epilepsy types treated with CBZ and VPA remained unchanged, whereas fewer cases of generalised epilepsy were treated with LTG in the new period. This trend was not associated with significant changes in seizure frequency, but rather linked to better control over de novo seizures in the third trimester. LEV was similar to CBZ and VPA with regard to levels of seizure control, and more effective than LTG. Generalised epilepsy accounted for 64% of the cases treated with LEV. CONCLUSIONS: The prescription pattern of AEDs during pregnancy has changed in Spain, with diminishing use of CBZ, phenytoin, and phenobarbital. Changes also reflect the type of epilepsy, since there is less use of LTG for generalised epilepsy. LEV provides similar seizure control to that of the older AEDs, and it is more effective and better than LTG.

Guía oficial de la Sociedad Española de Neurología de práctica clínica en epilepsia. Epilepsia en situaciones especiales: comorbilidades, mujer y anciano / The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients

Introducción: En el tratamiento de la epilepsia existen una serie de comorbilidades y grupos poblacionales (mujeres en edad fértil y ancianos) para los cuales podemos encontrar limitaciones en el manejo y precisar ajustes del tratamiento. Desarrollo: Búsqueda de artículos en Pubmed y recomendaciones de las Guías de práctica clínica en epilepsia y sociedades científicas más relevantes referentes la epilepsia en situaciones especiales (comorbilidades, mujeres en edad fértil, ancianos). Se clasifican las evidencias y recomendaciones según los criterios pronósticos del Oxford Center of Evidence-Based Medicine (2001) y de la European Federation of Neurological Societies (2004) para las actuaciones terapéuticas. Conclusiones: En las diversas comorbilidades, es necesaria una adecuada selección del tratamiento para mejorar la eficacia con el menor número de efectos secundarios. En la epilepsia catamenial es necesario un ajuste de la medicación antiepiléptica y/u hormonal, para poder controlar correctamente las crisis. La exposición a fármacos antiepilépticos durante la gestación aumenta el riesgo de malformaciones congénitas (MC) y puede afectar al crecimiento fetal y/o al desarrollo cognitivo. En el puerperio se aconseja la lactancia materna, vigilando los efectos adversos si se usan fármacos sedantes. Finalmente, los ancianos son una población muy susceptible de presentar epilepsia y que tiene unas características diferenciales con respecto a otros grupos de edad para el diagnóstico y el tratamiento. Estos pacientes pueden presentar con mayor frecuencia limitaciones terapéuticas por sus comorbilidades, pero suelen responder mejor al tratamiento y a dosis más bajas que en el resto de grupos de edad

Introduction: The characteristics of some population groups (patients with comorbidities, women of childbearing age, the elderly) may limit epilepsy management. Antiepileptic treatment in these patients may require adjustments. Development: We searched articles in Pubmed, clinical practice guidelines for epilepsy, and recommendations by the most relevant medical societies regarding epilepsy in special situations (patients with comorbidities, women of childbearing age, the elderly). Evidence and recommendations are classified according to the prognostic criteria of Oxford Centre of Evidence-Based Medicine (2001) and the European Federation of Neurological Societies (2004) for therapeutic interventions. Conclusions: Epilepsy treatment in special cases of comorbidities must be selected properly to improve efficacy with the fewest side effects. Adjusting antiepileptic medication and/or hormone therapy is necessary for proper seizure management in catamenial epilepsy. Exposure to antiepileptic drugs (AED) during pregnancy increases the risk of birth defects and may affect fetal growth and/or cognitive development. Postpartum breastfeeding is recommended, with monitoring for adverse effects if sedative AEDs are used. Finally, the elderly are prone to epilepsy, and diagnostic and treatment characteristics in this group differ from those of other age groups. Although therapeutic limitations may be more frequent in older patients due to comorbidities, they usually respond better to lower doses of AEDs than do other age groups

The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients.

INTRODUCTION: The characteristics of some population groups (patients with comorbidities, women of childbearing age, the elderly) may limit epilepsy management. Antiepileptic treatment in these patients may require adjustments. DEVELOPMENT: We searched articles in Pubmed, clinical practice guidelines for epilepsy, and recommendations by the most relevant medical societies regarding epilepsy in special situations (patients with comorbidities, women of childbearing age, the elderly). Evidence and recommendations are classified according to the prognostic criteria of Oxford Centre of Evidence-Based Medicine (2001) and the European Federation of Neurological Societies (2004) for therapeutic interventions. CONCLUSIONS: Epilepsy treatment in special cases of comorbidities must be selected properly to improve efficacy with the fewest side effects. Adjusting antiepileptic medication and/or hormone therapy is necessary for proper seizure management in catamenial epilepsy. Exposure to antiepileptic drugs (AED) during pregnancy increases the risk of birth defects and may affect fetal growth and/or cognitive development. Postpartum breastfeeding is recommended, with monitoring for adverse effects if sedative AEDs are used. Finally, the elderly are prone to epilepsy, and diagnostic and treatment characteristics in this group differ from those of other age groups. Although therapeutic limitations may be more frequent in older patients due to comorbidities, they usually respond better to lower doses of AEDs than do other age groups.

Malformaciones y muerte fetal en el registro español de fármacos antiepilépticos y embarazo: resultados a los 6 años / Malformations and fetal death in the Spanish antiepileptic drug and pregnancy registry: results at 6 years

Introducción. Los registros de embarazadas epilépticas proporcionan información fiable sobre los riesgos asociados al tratamiento antiepiléptico durante el embarazo. Con este fin se está realizado el registro EURAP, que es un estudio prospectivo observacional internacional que incluye mujeres tratadas con fármacos antiepilépticos (FAE) durante la concepción. Los datos de los centros españoles que participan en el registro reflejan cuál es la realidad en nuestro medio. Objetivos. Estudiar la incidencia de malformaciones congénitas (MCM) y/o muerte fetal perinatal (MFP), así como los posibles factores relacionados con las mismas en el registro EURAP España. Material y métodos. Tras el consentimiento informado las pacientes son incluidas en el registro prospectivo y son evaluadas en diferentes periodos: al inicio del embarazo, al final del segundo y tercer trimestre, después del parto y al año del nacimiento. Las variables que se analizan son: datos demográficos, tipo de epilepsia y frecuencia de crisis durante el embarazo, los FAE y dosis, otros tóxicos potenciales, uso de ácido fólico y dosis, complicaciones obstétricas y datos sobre el recién nacido. Tras 6 años de seguimiento (junio 2001- octubre 2007) se analizan los resultados de este registro en España, con especial énfasis en la incidencia de MCM y MFP. Resultados. De un total de 540 casos incluidos en el registro, son prospectivos (incluidos antes de la semana 16) 490 casos y disponemos de todos los datos para el análisis en 368. Presentaron MCM el 5% (n=13) de los neonatos expuestos a monoterapia y el 12% (n=6) de los expuestos a politerapia (p=0,08). Todas las politerapias asociadas a MCM incluían el ácido valproico. De las variables estudiadas sólo el bajo peso al nacer y el fármaco utilizado mostraron una asociación estadísticamente significativa con MCM y MFP. El porcentaje de MCM fue superior para el ácido valproico, particularmente a dosis igual o superior a 1.000 mg (16%), aunque las diferencias no fueron estadísticamente significativas. La mayoría de las pacientes estaban en monoterapia (83%) con dosis bajas de FAE y tomaban 5 mg de ácido fólico. Conclusiones. Los hijos de pacientes en politerapia, particularmente si incluyen el ácido valproico, son los que presentan más MCM. De los pacientes en monoterapia únicamente el peso al nacer y el FAE presentaban asociación significativa con MCM/MFP. En nuestra serie, el ácido valproico presenta más riesgo que la lamotrigina y no se observan diferencias respecto a carbamazepina (AU)

Introduction: Pregnancy registries provide trustworthy information about the risks associated to antiepileptic drugs (AEDs). EURAP is a Prospective International Registry which include patients who takes AEDs at the time of conception. The data of the Spanish centers which are contributing to EURAP reflects the reality of our milieu. Objectives: To study the incidence of major congenital malformations (MCM) /and/or fetal-perinatal death (MFP) and determine his relationship to AEDs in the Spanish EURAP registry. Methods: After informed consent, patients were included in the prospective Registry and evaluated: at the beginning, at the end of the second and third trimester, after delivery and one year after birth. A variety of variables were collected: demographic, type of epilepsy, frequency of seizures during pregnancy, AEDs and dose, potential toxics, folate use and dose, obstetric complications and information of the newborn. After 6 years of recruitment (June 2001-October 2007) we analyzed the results of this Registry in Spain with special attention on the incidence of major congenital malformations and foetal-perinatal death. Results: Of a whole of 540 cases included in the Registry, 490 were prospective (included before the 16th week), of these we had complete information in 368 cases. Major congenital maLformations were present in 5% (n=13) of the child exposed to monotherapy and 12% (n=6) of those exposed to polytherapy (p=0.08). All polytherapy combinations with MCM, contained valproate. Of the variables analyzed only low weight at birth and the AEDs used showed statistically significant association with MCM and MFP. The percentage of MCM was superior for valproate, particularly at doses equal or superior of 1000 mg/day (16%), although differences were not statistically significant. The majority of ours patients were on monotherapy (83%) with AEDs at low doses and were taking 5 mg of folate. Conclusions: Patients on polytherapy, particularly those with valproate in combination present more risk of MCM. For monotherapy exposures only weight at birth and the AEDs used have association statistically significant with MC/MFP. Valproate in our series presents more risk than lamotrigine and does not show differences with regard to carbamazepine (AU)

Fármacos antiepiléticos clásicos y de nueva generación: diferencias de sexo en la efectividad / Clasic antiepileptic and new generation antiepileptic drugs: gender differences

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[Integrated attention of epileptic women]. / Atención integrada a la mujer epiléptica.

INTRODUCTION: The treatment of epileptic seizures is only one aspect of the integrated treatment of epileptic women. DEVELOPMENT: Treatment should take into account, apart from the control of seizures, the short and long term side effects of antiepileptic drugs (AEDs), the effect of sex hormones on seizures, the effect of epilepsy and the AEDs on reproductive well being, and the social and psychological problems of these patients. Integrated attention of these patients should give epileptic women information and education so that they may participate effectively in matters affecting them. CONCLUSION: In this paper we review the special characteristics of treatment of epileptic women and summarize several different guidelines regarding this.

Epilepsia y embarazo / Pregnancy and epilepsy

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Atención integrada a la mujer epiléptica / Integrated attention of epileptic women

Introducción. El tratamiento de las crisis epilépticas es sólo uno de los aspectos de la atención integrada a la mujer epiléptica. Desarrollo. El tratamiento debe tener en cuenta, aparte del control de las crisis, los efectos secundarios a corto y largo plazo de los fármacos antiepilépticos (FAE), el efecto de las hormonas reproductoras sobre las crisis, el impacto de la epilepsia y de los FAE sobre el bienestar reproductor y también la problemática social y psicológica de estas pacientes. La atención integrada debe proporcionar a la mujer con epilepsia información y educación, lo cual le permitirá participar de forma eficaz en las decisiones a su respecto. Conclusión. Este artículo es una revisión de las peculiaridades del tratamiento de la epilepsia en la mujer y es un resumen de las diferentes guías de consenso al respecto (AU)

Neuroradiological and clinical findings in rhombencephalosynapsis.

Rhombencephalosynapsis is an unusual disorder characterised by maldevelopment of the rhombencephalon, sometimes with supratentorial midline anomalies. We report MRI findings in a 39-year-old woman, the oldest in the literature. MRI demonstrated hypoplasia of the cerebellar vermis, with fusion of the cerebellar hemispheres and abnormally oriented folia. Supratentorial anomalies were also seen.