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INTRODUCTION: Post-authorisation studies are important to confirm whether the outcomes of clinical trials are reproduced in usual clinical practice. AIMS: To evaluate the effectiveness and safety of fingolimod in clinical practice in the province of Alicante. PATIENTS AND METHODS: A retrospective multi-centre study was conducted with remitting multiple sclerosis patients treated with fingolimod. Demographic, clinical and pharmacological data were collected. We report on the effectiveness of the drug -annualised relapse rate (ARR) and percentage of patients free from attacks- at one and at two years after treatment in relation to the previous year, and data concerning side effects are also provided. RESULTS: The sample consisted of 89 patients. Previous treatment was with immunomodulators (interferon beta or glatiramer acetate) in 54 patients and natalizumab in 32. Fifty patients changed due to failure with the immunomodulator and 31 owing to positive serology for JC virus (JCV+). Overall ARR decreased by 67.3% the first year (p < 0.0001) and by 84.1% the second (p = 0.0078). It diminished in patients with immunomodulator failure (85.6% the first year, p < 0.0001; 88.9% the second year, p = 0.0039) and increased in a non-significant manner in JCV+ patients in the first year. The percentage of patients free from relapses in the overall population increased from 32.6% to 68.1% in the first year (p < 0.0019) and to 82.6% in the second (p = 0.0215). This increase was not observed in JCV+ patients. Side effects were reported by 13 patients, which led to the drug being withdrawn in two of them. CONCLUSION: In clinical practice in the province of Alicante, levels of effectiveness and safety of fingolimod proved to be slightly higher than those found in clinical trials.

TITLE: Fingolimod: efectividad y seguridad en la practica clinica habitual. Estudio observacional, retrospectivo y multicentrico en la provincia de Alicante.Introduccion. Los estudios postautorizacion son importantes para confirmar si los resultados de los ensayos clinicos se reproducen en la practica clinica habitual. Objetivo. Evaluar la efectividad y seguridad del fingolimod en la practica clinica en la provincia de Alicante. Pacientes y metodos. Estudio multicentrico retrospectivo de pacientes con esclerosis multiple remitente tratados con fingolimod. Se recogen las caracteristicas demograficas, clinicas y farmacologicas. Se describe la efectividad del farmaco ­tasa anualizada de brotes (TAB) y porcentaje de pacientes libres de brotes­ al año y a los dos años de tratamiento en relacion con el año previo y datos de efectos secundarios. Resultados. Se incluyo a 89 pacientes. El tratamiento previo fue inmunomodulador (interferon beta o acetato de glatiramero) en 54 pacientes y natalizumab en 32. Cincuenta pacientes cambiaron por fracaso con el inmunomodulador y 31 por serologia positiva del virus JC (VJC+). La TAB global disminuyo el 67,3% el primer año (p < 0,0001) y el 84,1% el segundo (p = 0,0078). Disminuyo en los pacientes con fracaso del inmunomodulador (el 85,6% el primer año, p < 0,0001; el 88,9% el segundo año, p = 0,0039) y aumento de forma no significativa en los pacientes VJC+ en el primer año. El porcentaje de pacientes libres de brotes en la poblacion global aumento del 32,6 al 68,1% en el primer año (p < 0,0019) y al 82,6% en el segundo (p = 0,0215). Este aumento no se observo en los pacientes VJC+. Trece pacientes tuvieron efectos secundarios, que obligaron a la retirada del farmaco en dos de ellos. Conclusion. En la practica clinica de la provincia de Alicante, el fingolimod mostro una efectividad y una seguridad ligeramente superiores a las de los ensayos clinicos.

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INTRODUCTION: To date, epidemiological studies on multiple sclerosis in Spain have been basically prevalence studies, and the data on incidence recorded have been the result of different methodologies, with no definition of the criteria for inclusion. OBJECTIVE: To carry out a study of incidence with prospective collection/review of cases over a prolonged period of time. PATIENTS AND METHODS: Over 12 years, between 1 March 1986 and 31 December 1997, we collected data prospectively for patients with a definite diagnosis of multiple sclerosis. The year of incidence was considered to be when the patient fulfilled clinical criteria for diagnosis of the disease. RESULTS: On 31 December 1997 in the Alcoi Health District there were 54 patients with clinically defined multiple sclerosis (a prevalence of 41.28 cases per 100,000 inhabitants). Of these, 45 patients were diagnosed during the period studied, with an average incidence of 2.82 cases per 100,000 inhabitants per year. Only 15 patients were confirmed before 1986. CONCLUSIONS: This is the most prolonged study of the incidence of multiple sclerosis carried out in Spain. The figures found for incidence are in contrast to those found in previous years for prevalence and incidence. Analysis of the data suggests that the incidence of multiple sclerosis in the Alcoi district has changed and has increased since the second half of the 1980s.

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INTRODUCTION: The epidemiological studies done in Spain in recent years show higher figures for the prevalence of multiple sclerosis than before. Spain is therefore now in the area with a high risk of contracting the disease. OBJECTIVE: We have made a new study to confirm the current prevalence of the disorder in the Alcoi Health District. PATIENTS AND METHODS: Between 1 March 1986 and the prevalence day, 31 December 1997 we recorded the patients with definite or probable multiple sclerosis, as defined on Poser's criteria, after intensive fieldwork and reevaluation of all possible patients by a neurologist from the Neurology Unit. On the prevalence day there were 130,786 inhabitants in the district. RESULTS: On the prevalence day we found 54 patients with definite multiple sclerosis and no patient with probable multiple sclerosis. The rate of prevalence was 41.28 cases per 100,000 inhabitants (95% CI: 31-53.6). During the study we counted an incidence of 45 cases with an average rate of 2.82 cases per 100,000 inhabitants per year. We also describe the clinical characteristics of the patients. CONCLUSIONS: The rate of prevalence found is much higher than that described for the district in studies using similar methodology. This increase, together with the discrepancy between the incidence found and the prevalence, makes us consider that possibly the prevalence has increased in recent years.

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Introducción. Los estudios epidemiológicos sobre esclerosis múltiple en España han sido hasta la fecha estudios fundamentalmente de prevalencia, y los datos de incidencia descritos se han recogido con metodología dispar, sin precisar los criterios de inclusión.Objetivo. Realizar un estudio de incidencia con recogida prospectiva de los casos a lo largo de un período prolongado de tiempo. Pacientes y métodos. A lo largo de 12 años, desde el 1 de marzo de 1986 al 31 de diciembre de 1997, se han recogido de forma prospectiva aquellos enfermos con diagnóstico de esclerosis múltiple definida. Se ha considerado como año de incidencia aquel en el que los pacientes cumplían criterios clínicos de la enfermedad. Resultados. El 31 de diciembre de 1997 había en el área de Alcoi 54 pacientes con esclerosis múltiple clínicamente definida (prevalencia de 41,28 casos por 100.000 habitantes). De ellos, 45 pacientes fueron incidentes a lo largo del período del estudio, con una tasa media de incidencia de 2,82 casos por 100.000 habitantes y año. Únicamente 15 pacientes fueron incidentes con anterioridad a 1986. Conclusiones. Este estudio es el más prolongado de los realizados sobre la incidencia de la esclerosis múltiple en España. Las cifras de incidencia halladas contrastan con los datos de prevalencia y la incidencia de los años anteriores. El análisis de los datos sugiere que la incidencia de la esclerosis múltiple en el área de Alcoi ha variado, incrementándose desde la segunda mitad de los años 80 (AU)

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Introducción. Los estudios epidemiológicos llevados a cabo los últimos años en España muestran cifras de prevalencia de la esclerosis múltiple superiores a las anteriormente descritas, y sitúan a nuestro país dentro de un área de riesgo elevado de padecer la enfermedad. Objetivo. Se ha realizado un nuevo estudio en el área sanitaria de Alcoi para comprobar la prevalencia actual de la enfermedad. Pacientes y métodos. Desde el 1 de marzo de 1986 hasta el día de prevalencia, el 31 de diciembre de 1997, se han recogido aquellos pacientes con diagnóstico de esclerosis múltiple definida o probable según los criterios de Poser, tras realizar un intensivo trabajo de campo y reevaluar a todos los posibles pacientes por un neurólogo de la Unidad de Neurología. El día de prevalencia el número de habitantes del área era 130.786. Resultados. El día de prevalencia se encontraron 54 pacientes con esclerosis múltiple definida y ningún paciente con esclerosis múltiple probable. La tasa de prevalencia fue de 41,28 casos por 100.000 habitantes (IC del 95 por ciento: 31-53,6). A lo largo del estudio se contabilizaron 45 casos incidentes con una tasa media de 2,82 casos por 100.000 habitantes y año. Se describen asimismo las características clínicas de los pacientes. Conclusiones. La tasa de prevalencia hallada es muy superior a la descrita previamente en la zona con estudios de similar metodología. Este incremento, junto a la discrepancia entre la incidencia encontrada y la prevalencia, hacen pensar en la posibilidad de un aumento de la prevalencia en los últimos años (AU)

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Epidemiological studies performed directly on the population show a prevalence of Friedreich's ataxia (FA) from 1 to 4.7 cases/100,000 inhabitants. An indirect epidemiological approach can be achieved using genetic methods like consanguinity studies to determine the frequency of a mutated gene and the incidence of certain diseases in the population. We obtained consanguinity data of a series of FA patients in Valencia, Spain and the figures on consanguinity in the general population that were estimated according to the Archive of Dispensations given by the Catholic church for consanguineous marriages. From these data, the frequency of the FA gene was calculated as 1/127. From these data, applying the Hardy-Weinberg principle, the frequency of the carriers was 1/64 and the incidence was 6.18/100,000 live births. Assuming a life expectancy of FA of 45 years, the prevalence was 3.83/100,000 inhabitants. These figures are in the same range as those obtained in population studies.

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Friedreich's ataxia (FA) is a progressive degenerative disease involving both central and peripheral nervous system. It is an autosomal recessive hereditary disorder, which begins around puberty and has an unknown genetic basis and biochemical defect. The recent mapping of FA locus in human chromosome 9 by means of the analysis of the molecular genetic linkage has permitted to evaluate FA genetics with polymorphic genetic markers (RFLPs) that are secreted linked with the FA gene. The normal and mutant allele secretion of FA was evaluated in ten Spanish families with one or two members with FA by means of several cloned probes (MCT112, DR47, D9S1 and HHH220), localized in chromosome 9 and strongly linked to FA gene, with the aim of achieving a predictive diagnosis of relatives in the pediatric age and to detect healthy carriers. In 9 out of 10 families some totally or partially informative RFLP were found. In 5 of 6 relatives in pediatric age the future development of the disease could be ruled out. By contrast, the carrier status could only be identified in three relatives. In a family with two affected children a genetic recombinant for D9S1 was found. Remarkably, one of them had a better clinical evolution and preserved tendon reflexes in lower limbs.

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We report a case of Marchiafava-Bignami's disease with acute evolution. Pathological examination was carried out and a cavitary lesion with discontinuous longitudinal extension was found throughout the corpus callosum. CT had shown a narrow hypodense area symmetrically localized just anterior to the frontal horns of the lateral ventricles, corresponding to the genus of the corpus callosum. The literature is reviewed, the anatomical-radiological correlations are discussed, and the possibility of the diagnosis of this condition during life is commented.

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Three patients with hemichorea and ten with dystonia of vascular origin are reported. Five were secondary to ischemic infarcts, two to lacunar infarcts, three to intraparenchymal hematoma, and in the remaining three the type of lesion could not be determined. The patients with chorea, as opposed to those with dystonia, presented abruptly immediately after the stroke, and had a regressive evolution and good therapeutic response. The type of dyskinesia was not useful to identify the precise localization of the lesion or to determine its nature. In addition, in 5 patients multiple lesions were found and 5 had release of archaic reflexes or cortical atrophy in CT; this shows the importance of the overall functional impairment and focal lesions in the genesis of dyskinesia. There were sensory deficits in 7 patients. In 2 patients lesions were not found in the CT in spite of the presence of previous hemiparesis; this suggests that this technique has limitations to discover focal cerebral lesions in patients with focal or hemicorporal dyskinesia.

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