Comparison of two high doses of oral methylprednisolone for multiple sclerosis relapses: a pilot, multicentre, randomized, double-blind, non-inferiority trial.

BACKGROUND AND PURPOSE: Oral or intravenous methylprednisolone (≥500 mg/day for 5 days) is recommended for multiple sclerosis (MS) relapses. Nonetheless, the optimal dose remains uncertain. We compared clinical and radiological effectiveness, safety and quality of life (QoL) of oral methylprednisolone [1250 mg/day (standard high dose)] versus 625 mg/day (lesser high dose), both for 3 days] in MS relapses. METHODS: A total of 49 patients with moderate to severe MS relapse within the previous 15 days were randomized in a pilot, double-blind, multicentre, non-inferiority trial (ClinicalTrial.gov, NCT01986998). The primary endpoint was non-inferiority of the lesser high dose by Expanded Disability Status Scale (EDSS) score improvement on day 30 (non-inferiority margin, 1 point). The secondary endpoints were EDSS score change on days 7 and 90, changes in T1 gadolinium-enhanced and new/enlarged T2 lesions on days 7 and 30, and safety and QoL results. RESULTS: The primary outcome was achieved [mean (95% confidence interval) EDSS score difference, -0.26 (-0.7 to 0.18) at 30 days (P = 0.246)]. The standard high dose yielded a superior EDSS score improvement on day 7 (P = 0.028). No differences were observed in EDSS score on day 90 (P = 0.352) or in the number of T1 gadolinium-enhanced or new/enlarged T2 lesions on day 7 (P = 0.401, 0.347) or day 30 (P = 0.349, 0.529). Safety and QoL were good at both doses. CONCLUSIONS: A lesser high-dose oral methylprednisolone regimen may not be inferior to the standard high dose in terms of clinical and radiological response.

The Mataró Stroke Registry: a 10-year registry in a community hospital.

INTRODUCTION: A prospective stroke registry leads to improved knowledge of the disease. We present data on the Mataró Hospital Registry. METHODS: In February-2002 a prospective stroke registry was initiated in our hospital. It includes sociodemographic data, previous diseases, clinical, topographic, etiological and prognostic data. We have analyzed the results of the first 10 years. RESULTS: A total of 2,165 patients have been included, 54.1% male, mean age 73 years. The most frequent vascular risk factor was hypertension (65.4%). Median NIHSS on admission: 3 (interquartile range, 1-8). Stroke subtype: 79.7% ischemic strokes, 10.9% hemorrhagic, and 9.4% TIA. Among ischemic strokes, the etiology was cardioembolic in 26.5%, large-vessel disease in 23.7%, and small-vessel in 22.9%. The most frequent topography of hemorrhages was lobar (47.4%), and 54.8% were attributed to hypertension. The median hospital stay was 8 days. At discharge, 60.7% of patients were able to return directly to their own home, and 52.7% were independent for their daily life activities. After 3 months these percentages were 76.9% and 62.9%, respectively. Hospital mortality was 6.5%, and after 3 months 10.9%. CONCLUSIONS: Our patient's profile is similar to those of other series, although the severity of strokes was slightly lower. Length of hospital stay, short-term and medium term disability, and mortality rates are good, if we compare them with other series.

Rapid assessment of transient ischaemic attack in a hospital with no on-call neurologist.

BACKGROUND: Risk of stroke soon after a transient ischaemic attack (TIA) is high. Urgent care can reduce this risk. Our aim is to describe and evaluate the efficacy of rapid assessment of TIA patients in a hospital without a neurologist available 24 hours a day. METHODS: In February 2007, we set up a protocol of rapid management of patients with symptoms consistent with acute TIA, with the aim of prioritising urgent care and reducing hospital admissions, without increasing risk of recurrences. We analyse our results since the protocol was implemented with particular focus on the analysis of delay in neurological and neurovascular assessment, percentage and reasons for hospitalisation, and stroke recurrence rates after 3 months. RESULTS: Four hundred and eleven patients were studied, with a final diagnosis of TIA in 282 (68.6%). Among other diagnoses, the most frequent were a vasovagal reaction (5.6%) and confusional syndrome (4.6%). Delay between emergency arrival and neurovascular assessment was <24h in 82% of the cases, and <48 h in 93%. After neurological evaluation, 28.7% of the patients were immediately admitted to hospital (most common causes: severe stenosis of a large artery and crescendo TIA). The incidence of ischaemic stroke in TIA patients was 3.55% after 3 months and 70% of them suffered the recurrence within the first week after the initial TIA. CONCLUSIONS: In a hospital without a neurologist available 24 hours a day, early assessment and management of TIA patients can be carried out in accordance with the guidelines, and may avoid hospitalisation in most cases without increasing recurrence rates.

Gadolinium-enhanced brain lesions in multiple sclerosis relapse.

OBJECTIVE: To study the clinico-radiological paradox in multiple sclerosis (MS) relapse by analyzing the number and location of gadolinium-enhanced (Gd+) lesions on brain MRI before methylprednisolone (MP) treatment. METHODS: We analyzed brain MRI from 90 relapsed MS patients in two Phase IV multicenter double-blind randomized clinical trials that showed the noninferiority of different routes and doses of MP administration. A 1.5- or 3-T brain MRI was performed at baseline before MP treatment and within 15 days of symptom onset. The number and location of Gd+ lesions were analyzed. Associations were studied using univariate analysis. RESULTS: Sixty-two percent of patients had at least 1 Gd+ brain lesion; the median number was 1 (interquartile range 0-4), and 41% of patients had 2 or more lesions. The most frequent location of Gd+ lesions was subcortical (41.4%). Gd+ brain lesions were found in 71.4% of patients with brainstem-cerebellum symptoms, 57.1% with spinal cord symptoms and 55.5% with optic neuritis (ON). Thirty percent of patients with brain symptoms did not have Gd+ lesions, and only 43.6% of patients had symptomatic Gd+ lesions. The univariate analysis showed a negative correlation between age and the number of Gd+ lesions (p=0.002). CONCLUSION: Most patients with relapse showed several Gd+ lesions on brain MRI, even when the clinical manifestation was outside of the brain. Our findings illustrate the clinico-radiological paradox in MS relapse and support the value of brain MRI in this scenario.

Gadolinium-enhanced brain lesions in multiple sclerosis relapse / Lesiones cerebrales captantes de gadolinio en el brote de los pacientes con esclerosis múltiple

Objective: To study the clinico-radiological paradox in multiple sclerosis (MS) relapse by analyzing the number and location of gadolinium-enhanced (Gd+) lesions on brain MRI before methylprednisolone (MP) treatment. Methods: We analyzed brain MRI from 90 relapsed MS patients in two Phase IV multicenter double-blind randomized clinical trials that showed the noninferiority of different routes and doses of MP administration. A 1.5- or 3-T brain MRI was performed at baseline before MP treatment and within 15 days of symptom onset. The number and location of Gd+ lesions were analyzed. Associations were studied using univariate analysis. Results: Sixty-two percent of patients had at least 1 Gd+ brain lesion; the median number was 1 (interquartile range 0–4), and 41% of patients had 2 or more lesions. The most frequent location of Gd+ lesions was subcortical (41.4%). Gd+ brain lesions were found in 71.4% of patients with brainstem-cerebellum symptoms, 57.1% with spinal cord symptoms and 55.5% with optic neuritis (ON). Thirty percent of patients with brain symptoms did not have Gd+ lesions, and only 43.6% of patients had symptomatic Gd+ lesions. The univariate analysis showed a negative correlation between age and the number of Gd+ lesions (p = 0.002). Conclusion: Most patients with relapse showed several Gd+ lesions on brain MRI, even when the clinical manifestation was outside of the brain. Our findings illustrate the clinico-radiological paradox in MS relapse and support the value of brain MRI in this scenario. (AU)

Objetivo: Estudiar la paradoja clínico-radiológica en el brote de la esclerosis múltiple (EM) mediante el análisis de lesiones captantes de gadolinio (Gd+) en la RM cerebral antes del tratamiento con metilprednisolona (MP). Métodos: Analizamos la RM cerebral basal de 90 pacientes con EM en brote de 2 ensayos clínicos aleatorizados multicéntricos fase IV que demostraron la no inferioridad de diferentes vías y dosis de MP, realizadas antes del tratamiento con MP y en los 15 días siguientes a la aparición de los síntomas. Se analizaron el número y la localización de las lesiones Gd+. Se estudiaron las asociaciones mediante análisis univariado. Resultados: El 62% de los pacientes tenía al menos una lesión Gd+ cerebral y el 41% de los pacientes tenía 2 o más lesiones. La localización más frecuente fue la subcortical (41,4%). Se encontraron lesiones Gd+ cerebrales en el 71,4% de los pacientes con síntomas de tronco cerebral o cerebelo, en el 57,1% con síntomas medulares y en el 55,5% con neuritis óptica. El 30% de los pacientes con síntomas cerebrales no tenían lesiones Gd+ y sólo el 4,.6% de los pacientes tenían lesiones Gd+ sintomáticas. El análisis univariante mostró una correlación negativa entre la edad y el número de lesiones Gd+ (p = 0,002). Conclusiones: La mayoría de los pacientes en brote mostraron varias lesiones Gd+ en la RM cerebral, incluso cuando la manifestación clínica fue medular u óptica. Nuestros hallazgos ilustran la paradoja clínico-radiológica en el brote de la EM y apoyan el valor de la RM cerebral en este escenario. (AU)

Registro de Ictus del Hospital de Mataró: 10 años de registro en un hospital comarcal / The Mataró Stroke Registry: a 10-year registry in a community hospital

Introducción: Un registro prospectivo de ictus permite mejorar el conocimiento de la historia natural de la enfermedad. Presentamos los datos del Registro del Hospital de Mataró. Métodos: En febrero de 2002 se inició en nuestro hospital el registro prospectivo de pacientes ingresados con un ictus agudo. Se recogen variables sociodemográficas, antecedentes, clínicas, topográficas, etiológicas y pronósticas. Analizamos los resultados obtenidos después de los primeros 10 años de registro. Resultados: Se han registrado 2.165 pacientes, el 54,1% varones, con una edad media de 73 años. El factor de riesgo más frecuente es la hipertensión (65,4%). Mediana de la NIHSS al ingreso: 3 (rango intercuartílico, 1-8). Un 79,7% han sido infartos cerebrales, un 10,9% hemorragias y un 9,4% AIT. De los isquémicos, la etiología ha sido cardioembólica en el 26,5%, aterotrombótica en el 23,7% y lacunar en el 22,9%. La localización más frecuente de las hemorragias ha sido lobar (47,4%), y se han atribuido a hipertensión el 54,8%. La mediana de la estancia hospitalaria ha sido de 8 días. Al alta, un 60,7% pudieron volver directamente al domicilio y un 52,7% eran independientes para las actividades de la vida diaria. A los 3 meses, las cifras fueron 76,9 y 62,9% respectivamente. La mortalidad intrahospitalaria ha sido del 6,5% y a los 3 meses del 10,9%. Conclusiones: El perfil de los pacientes en nuestra área no difiere de las otras series, aunque la severidad de los ictus ha sido discretamente menor. Constatamos unas cifras óptimas de estancia hospitalaria y de discapacidad y mortalidad tanto a corto como a medio plazo

Introduction: A prospective stroke registry leads to improved knowledge of the disease. We present data on the Mataró Hospital Registry. Methods: In February-2002 a prospective stroke registry was initiated in our hospital. It includes sociodemographic data, previous diseases, clinical, topographic, etiological and prognostic data. We have analyzed the results of the first 10 years. Results: A total of 2,165 patients have been included, 54.1% male, mean age 73 years. The most frequent vascular risk factor was hypertension (65.4%). Median NIHSS on admission: 3 (interquartile range, 1-8). Stroke subtype: 79.7% ischemic strokes, 10.9% hemorrhagic, and 9.4% TIA. Among ischemic strokes, the etiology was cardioembolic in 26.5%, large-vessel disease in 23.7%, and small-vessel in 22.9%. The most frequent topography of hemorrhages was lobar (47.4%), and 54.8% were attributed to hypertension. The median hospital stay was 8 days. At discharge, 60.7% of patients were able to return directly to their own home, and 52.7% were independent for their daily life activities. After 3 months these percentages were 76.9% and 62.9%, respectively. Hospital mortality was 6.5%, and after 3 months 10.9%. Conclusions: Our patient's profile is similar to those of other series, although the severity of strokes was slightly lower. Length of hospital stay, short-term and medium term disability, and mortality rates are good, if we compare them with other serie

[Cryptogenic infarct. A follow-up period of 1 year study]. / Infartos criptogénicos. Estudio de 1 año de seguimiento.

OBJECTIVE: To analyze the outcome of patients with a cryptogenic infarct (CI) after a follow-up period of 1 year. METHODS: From our prospective registry of stroke, during a 4-year period, we've identified 121 consecutive patients with a CI (15.1% of all infarcts). They have been followed up for 1 year and we have registered stroke recurrence, cardiovascular events and other incidences. RESULTS: Mean age 70.6 years-old, 53% male. Middle cerebral artery (MCA) was the most often involved territory (52 cases), 70% of them with cortical involvement. No patient died during admission, 95.8% received antiplatelet therapy and 4.1% oral anticoagulant. Fourteen patients were lost of follow-up. During 1-year period, atrial fibrillation (AF) was detected in 7 patients (6.54%), their mean age was 75 years-old, in 5 of them the CI was in MCA territory (4 with cortical involvement, 1 only deep infarct). Three patients (2.76%) suffered a recurrent ischemic stroke, in weeks 15, 16 and 44 after the CI. In all 3 cases the infarct was considered cryptogenic again. Two patients suffered a myocardial infarction and 4 died during follow-up period. CONCLUSION: In our series rate of stroke recurrence and cardiovascular events after a CI was low. An 11% of patients with a CI involving cortical MCA territory developed FA during the following year.

[Intracranial stenosis. Study and follow-up of 38 patients]. / Estenosis intracraneales. Estudio y seguimiento de 38 pacientes.

INTRODUCTION: To describe vascular risk factors of patients harboring intracranial arterial stenosis (IAS) as well their final outcome. METHODS: We reviewed clinical reports of all patients admitted to our Institution from April 1, 1999 to November 30, 2001 with the diagnosis of IAS. Diagnosis was made by means of magnetic resonance angiography (MRA) or four-vessels digital subtraction angiography. Thirty-eight patients harboring 56 IAS were identified. Mean follow-up was 18 months. Two control groups were selected: one was a group of 44 patients with stroke and embolic cardiopathy (EC) and the other was a group of 67 patients with stroke and extracranial stenosis without IAS. RESULTS: Mean age was 69.7 years, with male preponderance (76.3 %). Seventeen cases (44.7 %) had associated extracranial carotid stenosis greater than 50 %. Multiple IAS were found in 12 patients. Diabetes mellitus was significantly more frequent in the IAS group than in both control groups. On the other hand, cigarette smoking was more common in the IAS group with respect to the EC group. IAS was symptomatic in 25 cases, whereas in 13 patients IAS was found in the work-up for cerebral ischemia in another territory. From the group of symptomatic patients, 22 (88 %) had a Rankin scale 2 or lower on discharge and, in the long term follow-up, their incidence rate of recurrent ischemic stroke was 15 per 100 patients/year. CONCLUSIONS: Diabetes mellitus was the most specific risk factor for IAS. IAS was multiple in 32% of patients and in extracranial stenosis from moderate to severe degree was found in 44.7% of the cases. Stroke secondary to IAS caused a low dependency level at discharge. Incidence rate of recurrent ischemic stroke was 15 % patients/ year.

Infartos criptogénicos. Estudio de 1 año de seguimiento / Cryptogenic infarct. A follow-up period of 1 year study

Objetivo. Analizar la evolución de los pacientes con un infartocriptogénico (IC) tras 1 año de seguimiento.Método. De nuestro registro prospectivo de ictus, durante unperíodo de 4 años, identificamos 121 pacientes consecutivos con unIC (15,1% del total de infartos). Se recogen datos de recurrencia delictus, eventos cardiovasculares y otras incidencias tras 1 año de seguimiento.Resultados. Edad media: 70,6 años, 53,7% de varones. La arteriacerebral media (ACM) fue el territorio más afectado (52 casos), el70% de ellos con afectación cortical. Ningún paciente falleció duranteel ingreso, un 95,8% recibió tratamiento antiagregante y un4,1% anticoagulante. En 14 pacientes no se pudo completar el añode seguimiento por diferentes motivos.Durante el período de seguimiento se detectó fibrilación auricular(FA) a 7 pacientes (6,54%), su edad media fue 75 años y en 5 deellos el IC había sido en el territorio de la ACM (4 superficial y 1 profundo).Tres pacientes (2,76%) sufrieron una recurrencia de ictus isquémicoen las semanas 15, 16 y 44 después del IC. En los 3 casos elictus fue considerado de nuevo criptogénico. Dos pacientes sufrieronun infarto agudo de miocardio y 4 fallecieron (infarto de miocardio,neoplasia de esófago, neumonía y muerte súbita).Conclusión. En nuestra serie, la tasa de recurrencia y de episodioscardiovasculares en el primer año tras un IC es baja. Un 11% depacientes con un IC en el territorio cortical de la ACM desarrollaronuna FA en el año siguiente (AU)

Objective. To analyze the outcome of patients with a cryptogenicinfarct (CI) after a follow-up period of 1 year.Methods. From our prospective registry of stroke, during a4-year period, we’ve identified 121 consecutive patients with a CI(15.1% of all infarcts). They have been followed up for 1 year andwe have registered stroke recurrence, cardiovascular eventsand other incidences.Results. Mean age 70.6 years-old, 53 % male. Middle cerebralartery (MCA) was the most often involved territory (52 cases),70% of them with cortical involvement. No patient died duringadmission, 95.8% received antiplatelet therapy and 4.1% oralanticoagulant. Fourteen patients were lost of follow-up.During 1-year period, atrial fibrillation (AF) was detected in7 patients (6.54%), their mean age was 75 years-old, in 5 of themthe CI was in MCA territory (4 with cortical involvement, 1 onlydeep infarct). Three patients (2.76 %) suffered a recurrent ischemicstroke, in weeks 15, 16 and 44 after the CI. In all 3 cases theinfarct was considered cryptogenic again. Two patients suffereda myocardial infarction and 4 died during follow-up period.Conclusion. In our series rate of stroke recurrence and cardiovascularevents after a CI was low. An 11 % of patients with aCI involving cortical MCA territory developed FA during the followingyear (AU)

Reconocimiento de los síntomas del ictus y respuesta frente a ellos en la población / Knowledge about stroke symptoms and attitude towards them in the population

Introducción. Conocer el significado de los síntomas de un ictus y tener percepción de urgencia ante ellos es un factor decisivo para reducir la demora extrahospitalaria. El objetivo es analizar el grado de reconocimiento de sus síntomas en los pacientes con un ictus, su actitud ante ellos y los factores que influyen en el conocimiento de la enfermedad. Métodos. Se estudian prospectivamente 292 pacientes consecutivos diagnosticados de ictus mediante un protocolo de recogida de datos que incluye 76 variables. Se realiza análisis univariante y multivariante para identificar las variables que se asocian independientemente con una mejor interpretación de sus síntomas y percepción de urgencia. Resultados. Sólo un 34% de pacientes reconoció saber que estaba sufriendo un ictus. El antecedente de ictus previo (OR: 3,97), vivir en una residencia (odds ratio [OR]: 3,20), tener síntomas motores (OR: 1,92) y un ictus más grave (OR: 1,05) se asociaron de forma independiente a un mejor reconocimiento de los síntomas. Sólo un 31,8 % de pacientes (41% de los que reconocieron los síntomas del ictus) decidió acudir inmediatamente al hospital o llamó a una ambulancia. La etiología cardioembólica del infarto (OR: 2,62), no tener hipertensión (OR: 0,48) y reconocer correctamente sus síntomas (OR: 0,62) son factores asociados de forma independiente a una mayor percepción de urgencia. Conclusión. Sólo un 14 % de los pacientes tienen un buen conocimiento del ictus y actúan correctamente cuando éste ocurre. Es necesario desarrollar programas de formación de la población en los que se resalte la urgencia ante la presencia de síntomas sugestivos de ictus (AU)

Introduction. To know the meaning of stroke symptoms and to perceive them as an emergency is a decisive factor to reduce hospital admission delay. The aim of the study is to analyze the degree of recognition of stroke symptoms by the patients, their attitude towards them, and which factors contribute to a better knowledge on cerebrovascular diseases. Methods. A total of 292 patients diagnosed of stroke were studied prospectively, following a protocol designed for data collection that included 76 variables. Univariate and multivariate analyses were conducted to identify which variables were independently associated with a better interpretation of stroke symptoms and emergency perception. Results. Only 34% of all patients recognized they were suffering a stroke. The background that was independently associated with a better interpretation of symptoms included previous stroke (odds ratio [OR]: 3.97), institutionalized subjects (old people's home) (OR: 3.20), motor symptoms (OR: 1.92) and more serious stroke (OR: 1.05). Only 31% of all patients, 41% of whom had recognized stroke symptoms, decided to go immediately to hospital or call for an ambulance. Variables that were independently associated with a better perception of emergency included cardioembolic stroke (OR: 2.62), not having hypertension (OR: 0.48) and a correct interpretation of stroke symptoms (OR: 0.62). Conclusion. Only 14% of all patients have a good knowledge about stroke and correctly act when it occurs. It is necessary to develop education programs aimed at the population that emphasize the emergency when symptoms suggesting stroke appear (AU)

Miopatía inducida por colquicinacon miotonía asociada / Myopathy by colchicine with myotonia

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