[Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia]. / Fingolimod: efectividad y seguridad en la practica clinica habitual. Estudio observacional, retrospectivo y multicentrico en Galicia.

INTRODUCTION: The effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) have been proven in clinical trials. Yet, due to their limitations, it is important to know how it behaves under everyday clinical practice conditions. Hence, the aim of this study is to evaluate the effectiveness and safety of fingolimod after 12 months' usage in clinical practice in Galicia. PATIENTS AND METHODS: We conducted a retrospective, multi-centre study (n = 8) of patients with RRMS who were treated with one or more doses of fingolimod, 0.5 mg/day. Effectiveness was assessed -annualised relapse rate (ARR), changes in the score on the Expanded Disability Status Scale (EDSS), percentage of patients free from relapses, free from progression of disability and free from activity in resonance- for the total number of patients and according to previous treatment. Safety was assessed based on the percentage of patients who withdrew and presented adverse side effects. RESULTS: After 12 months' use, fingolimod reduced the ARR by 87% (1.7 to 0.23; p < 0.0001) and, consequently, 81% of patients were free from relapses. The score was reduced by 9%. In all, 91% of patients were free from progression of disability and 72% were free from resonance activity. No signs of disease activity were found in 43% of the patients. Most of the benefits of fingolimod differed depending on previous treatment. About a third of the patients reported adverse side effects, but only 2% of them withdrew for this reason. CONCLUSIONS: In clinical practice, most of the results on the effectiveness of the clinical trials conducted with fingolimod were observed during the first 12 months of treatment. A better safety profile was observed than that reported in the clinical trials.

TITLE: Fingolimod: efectividad y seguridad en la practica clinica habitual. Estudio observacional, retrospectivo y multicentrico en Galicia.Introduccion. La efectividad y seguridad del fingolimod en pacientes con esclerosis multiple remitente recurrente (EMRR) se demostro en ensayos clinicos. Sin embargo, por las limitaciones de estos, es importante saber como se comporta en condiciones de practica clinica habitual. Asi, el objetivo de este estudio es evaluar la efectividad y seguridad del fingolimod despues de 12 meses de uso en la practica clinica en Galicia. Pacientes y metodos. Estudio retrospectivo y multicentrico (n = 8) de pacientes con EMRR y tratados con una o mas dosis de fingolimod, 0,5 mg/dia. Se evaluo la efectividad ­tasa anualizada de brotes (TAB), cambio en la puntuacion de la escala expandida del estado de discapacidad (EDSS), porcentaje de pacientes libres de brotes, libres de progresion de discapacidad y libres de actividad en resonancia­ para el total de pacientes y segun tratamiento previo. Se evaluo la seguridad a partir del porcentaje de pacientes que discontinuaron y que presentaron efectos adversos. Resultados. Despues de 12 meses de uso, el fingolimod redujo un 87% la TAB (de 1,7 a 0,23; p < 0,0001) y, en consecuencia, un 81% de pacientes estuvo libre de brotes. La puntuacion de la EDSS disminuyo un 9%. Un 91% de pacientes estuvo libre de progresion de discapacidad y un 72%, libre de actividad en resonancia. En el 43% de los pacientes no se evidenciaron signos de la actividad de la enfermedad. La mayoria de los beneficios del fingolimod difirieron segun el tratamiento previo. Alrededor de un tercio de los pacientes comunicaron efectos adversos, pero solo el 2% discontinuo debido a ellos. Conclusiones. La mayoria de los resultados de efectividad de los ensayos clinicos del fingolimod se observa durante los 12 primeros meses de tratamiento en la practica clinica. Se observo un mejor perfil de seguridad al comunicado en los ensayos clinicos.

[Sensory symptoms in Parkinson's disease]. / Síntomas sensoriales en la enfermedad de Parkinson.

INTRODUCTION: In addition to the motor disturbances experienced by the patients suffering from Parkinson's disease (PD), several non-motor symptoms also affect the PD patients: neurobehavior symptoms (dementia, depression, anxiety, psychosis), autonomic (postural hypotension, urinary symptoms, gastro intestinal symptoms, diaphoresis), sleep disorders (insomnia, somnolence, REM sleep behavior disorder, apnea), sensitive-motor (fatigue, diplopia, restless legs syndrome), and sensory symptoms. DEVELOPMENT: We review the most relevant about sensory symptoms in PD: visual dysfunction, olfactory dysfunction, taste, hearing loss, and pain and other sensitive associate symptoms. CONCLUSIONS: Pain is frequently observed in patients with PD, being its prevalence high and probably infra diagnosed. Its identification and classification is very important for a correct treatment. Hyposmia is a common symptom in PD and could be a predictor of future PD. Visual dysfunction and hearing dysfunction among others must be considered in patients with PD.

[Restless legs syndrome]. / Síndrome de las piernas inquietas.

INTRODUCTION: Restless legs syndrome (RLS) is a movement disorder with a neurological origin that manifests in the form of sensory-motor symptoms which are located mainly in the lower limbs. DEVELOPMENT: We review the epidemiological, pathophysiological, clinical and therapeutic characteristics of this disease, with special emphasis on the diagnostic criteria. CONCLUSIONS: Diagnosis of RLS is mainly clinical and is based on the criteria established by the National Institutes of Health consensus development conference in 2002. There are specific criteria for special groups (the elderly with cognitive impairment and children) in which it is not possible to determine whether RLS exists or not using the usual diagnostic criteria.

Síndrome de las piernas inquietas / Restless legs syndrome

Resumen. Introducción. El síndrome de piernas inquietas (SPI) es un trastorno del movimiento de origen neurológico, que se manifiesta por clínica sensitivomotora localizada principalmente en las extremidades inferiores. Desarrollo. Se revisan las características epidemiológicas, fisiopatológicas clínicas y terapéuticas de esta enfermedad, y se hace un especial énfasis en los criterios diagnósticos. Conclusiones. El diagnóstico del SPI es eminentemente clínico y se basa en los criterios de la conferencia de consenso de los National Institutes of Health de 2002. Existen criterios específicos para grupos especiales (ancianos con deterioro cognitivo y niños) en los cuales no es posible determinar si existe SPI mediante los criterios diagnósticos habituales (AU)

Summary. Introduction. Restless legs syndrome (RLS) is a movement disorder with a neurological origin that manifests in the form of sensory-motor symptoms which are located mainly in the lower limbs. Development. We review the epidemiological, pathophysiological, clinical and therapeutic characteristics of this disease, with special emphasis on the diagnostic criteria. Conclusions. Diagnosis of RLS is mainly clinical and is based on the criteria established by the National Institutes of Health consensus development conference in 2002. There are specific criteria for special groups (the elderly with cognitive impairment and children) in which it is not possible to determine whether RLS exists or not using the usual diagnostic criteria (AU)