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

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 Side effects were reported by 13 patients, which led to the drug being withdrawn in two of them.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.

Switching from natalizumab to fingolimod: an observational study.

BACKGROUND: Multiple sclerosis patients who discontinue using natalizumab are at risk of a rebound in disease activity. However, the optimal alternative therapy is not currently known. AIMS OF THE STUDY: We report on clinical and MRI data and patient safety in a group of relapsing-remitting multiple sclerosis patients who tested seropositive for the JC virus and who have switched from natalizumab to fingolimod because of concerns regarding PML risks. METHODS: The test for JC virus antibodies was performed in 18 relapsing-remitting multiple sclerosis patients who were being treated with natalizumab for more than 1 year. Eight seropositive patients switched to fingolimod while the seronegative patients continued with natalizumab. RESULTS: After switching to fingolimod, five of eight patients (63%) experienced clinical relapses, and MRI activity was detected in six of eight patients (75%). Neither clinical relapses nor MRI activity was observed in the patients who continued with natalizumab. No serious adverse effects were detected. CONCLUSIONS: Natalizumab is an effective treatment for relapsing-remitting multiple sclerosis, but its discontinuation continues to be a complex problem. All of the therapies tried thus far, including fingolimod, have been unable to control the reactivation of the disease. Further studies addressing alternative therapies after natalizumab discontinuation are necessary.

Síndrome radiológico aislado / Radiologically isolated syndrome

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Utilización de levetiracetam intravenoso en un hospital general / The Use of intravenous levetiracetam in a general hospital

Introducción y objetivos. Aunque la vía oral es la forma habitual de administración de los fármacos antiepilépticos, en ciertas ocasiones se requiere la vía parenteral. El levetiracetam es el único de los nuevos fármacos antiepilépticos con posibilidad de administración por vía intravenosa. Se presenta un estudio de utilización de levetiracetam intravenoso en un hospital general, con evaluación de su eficacia y seguridad. Pacientes y métodos. Se analizaron de forma retrospectiva las historias clínicas de todos los pacientes ingresados en el hospital que fueron tratados con levetiracetam intravenoso durante el período de tiempo comprendido entre julio de 2007 y mayo de 2008. Resultados. Un total de 53 pacientes fue tratado con levetiracetam intravenoso. Aproximadamente la mitad de los pacientes (47%) había estado ingresada a cargo del servicio de neurología, seguido del servicio de neurocirugía (21%) y oncología (9%). La edad media fue de 52,2 años (rango: 9-87 años) y el 40% eran mujeres. Las crisis fueron sintomáticas en el 81%, y las etiologías más frecuentes fueron los ictus (40%) y los tumores cerebrales (33%). La presentación clínica más frecuente fueron las crisis epilépticas repetidas (47,2%) y el estado epiléptico (26,4%). Globalmente, el control de las crisis se consiguió en el 87% de los pacientes. No se detectaron efectos adversos graves atribuibles al tratamiento con levetiracetam. Conclusiones. El levetiracetam intravenoso parece ser un fármaco antiepiléptico eficaz y seguro en pacientes hospitalizados, especialmente en aquéllos que presentan comorbilidad asociada y/o plurimedicación (AU)

Introduction and aims. Although antiepileptic drugs are usually administered orally, sometimes they must be given intravenously. Levetiracetam is the only one of the new antiepileptic drugs that can be administered intravenously. In this study we report on the use of intravenous levetiracetam in a general hospital, while also evaluating its effectiveness and safety. Patients and methods. A retrospective analysis was conducted of the medical records of all hospital admissions that were treated with intravenous levetiracetam between July 2007 and May 2008. Results. A total of 53 patients were treated with intravenous levetiracetam. Approximately half the patients (47%) had been admitted to neurology, followed by neurosurgery (21%) and oncology (9%). The mean age was 52.2 years (range: 9-87 years) and 40% were females. Seizures were symptomatic in 81% of cases and the most common aetiologies were strokes (40%) and brain tumours (33%). The most frequent presenting symptoms were repeated epileptic seizures (47.2%) and epileptic status (26.4%). Overall, control of seizures was achieved in 87% of patients. No severe side-effects that could be attributed to levetiracetam therapy were detected. Conclusions. Intravenous levetiracetam seems to be an effective, safe antiepileptic drug in hospitalised patients, and especially so in those who present an associated comorbidity and/or who are on multiple drug therapy (AU)

[The use of intravenous levetiracetam in a general hospital]. / Utilización de levetiracetam intravenoso en un hospital general.

INTRODUCTION AND AIMS: Although antiepileptic drugs are usually administered orally, sometimes they must be given intravenously. Levetiracetam is the only one of the new antiepileptic drugs that can be administered intravenously. In this study we report on the use of intravenous levetiracetam in a general hospital, while also evaluating its effectiveness and safety. PATIENTS AND METHODS: A retrospective analysis was conducted of the medical records of all hospital admissions that were treated with intravenous levetiracetam between July 2007 and May 2008. RESULTS: A total of 53 patients were treated with intravenous levetiracetam. Approximately half the patients (47%) had been admitted to neurology, followed by neurosurgery (21%) and oncology (9%). The mean age was 52.2 years (range: 9-87 years) and 40% were females. Seizures were symptomatic in 81% of cases and the most common aetiologies were strokes (40%) and brain tumours (33%). The most frequent presenting symptoms were repeated epileptic seizures (47.2%) and epileptic status (26.4%). Overall, control of seizures was achieved in 87% of patients. No severe side-effects that could be attributed to levetiracetam therapy were detected. CONCLUSIONS: Intravenous levetiracetam seems to be an effective, safe antiepileptic drug in hospitalised patients, and especially so in those who present an associated comorbidity and/or who are on multiple drug therapy.

Trastorno del sueño asociado al tratamiento con rimonabant / Sleep disorders associated with treatment with rimonabant

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[Preadmission statins treatment in stroke patients: opportunity to treat high vascular risk patients]. / Antecedente del uso de estatinas en el ictus: oportunidad de mejora en el paciente con alto riesgo vascular por aterotrombosis.

AIM: To describe the use of preadmission statins in patients with cerebrovascular accident and the possible predictive factors. PATIENTS AND METHODS: Cross-sectional observational study of 795 consecutive patients with acute cerebrovascular accident. We assessed the differences among patients who were on preadmission statins (161) and those who were not (634), regarding vascular risk factors and clinical and neurosonological atherothrombotic disease markers. For univariate analysis, we used squared chi test, and for multivariate analysis, logistic regression analysis. RESULTS: Preadmission statins were 20.3%. In high vascular risk patients defined based on National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III), this reached 28% and it might be 72%. Predictive factors for preadmission statins use were, in a positive sense, the antecedent of hypercholesterolemia diagnosis (OR = 189; 95% CI = 58-615; p < or = 0.001) and stroke (OR = 2.1; 95% CI = 1.2-3.6; p < or = 0.01), and in a negative sense, smoking (OR = 0.38; 95% CI = 0.18-0.81; p = 0.012). CONCLUSIONS: In our population of patients with stroke, the predictive factors of preadmission statins did not adjust to the current therapeutic NCEP-ATP III recommendations; treatment with statins in high vascular risk population was way below the indications, it was 28% and it might be 72%.

[Lumbar puncture: its indications, contraindications, complications and technique]. / Punción lumbar: indicaciones, contraindicaciones, complicaciones y técnica de realización.

INTRODUCTION: Although first described over 100 years ago, lumbar puncture is still an important tool in the diagnosis of neurological diseases. In this article we review its indications, contraindications, the technique for carrying it out, the analysis of the cerebrospinal fluid and possible complications. DEVELOPMENT: The lumbar puncture has diagnostic and therapeutic indications. The chief diagnostic indications include infectious, inflammatory and neoplastic diseases affecting the central nervous system. Complications are infrequent, except for headaches and low back pain, but can be severe. Analysis of the cerebrospinal fluid must include a cell count and determination of the glucose and protein concentrations. The other analytical studies of cerebrospinal fluid must be conducted according to the diagnostic suspicion. CONCLUSION: The lumbar puncture in expert hands is a safe test. The health professional should be suitably familiar with its contraindications, the regional anatomy and the technique used to perform it.

Punción lumbar: indicaciones, contraindicaciones, complicaciones y técnica de realización / Lumbar puncture: Its indications, conraindications, complications and technique

Aunque se describió hace más de 100 años, la punción lumbar continúa siendo una importante herramientadiagnóstica en las enfermedades neurológicas. En este artículo se revisan sus indicaciones, contraindicaciones, técnica de realización, análisis del líquido cefalorraquídeo y posibles complicaciones. Desarrollo. La punción lumbar tiene indicacionesdiagnósticas y terapéuticas. Las principales indicaciones diagnósticas incluyen enfermedades infecciosas, inflamatorias y neoplásicas que afectan al sistema nervioso central. Las complicaciones, con la excepción de la cefalea y la lumbalgia, son infrecuentespero pueden ser graves. El análisis del líquido cefalorraquídeo debe incluir un conteo celular y la determinación de la concentración de glucosa y proteínas. El resto de los estudios analíticos en el líquido cefalorraquídeo debe realizarse en funciónde la sospecha diagnóstica. Conclusión. La punción lumbar en manos expertas es una prueba segura. Es necesario conocer adecuadamente sus contraindicaciones, la anatomía regional y su técnica de realización

Although first described over 100 years ago, lumbar puncture is still an important tool in thediagnosis of neurological diseases. In this article we review its indications, contraindications, the technique for carrying it out, the analysis of the cerebrospinal fluid and possible complications. Development. The lumbar puncture has diagnostic andtherapeutic indications. The chief diagnostic indications include infectious, inflammatory and neoplastic diseases affecting the central nervous system. Complications are infrequent, except for headaches and low back pain, but can be severe. Analysisof the cerebrospinal fluid must include a cell count and determination of the glucose and protein concentrations. The other analytical studies of cerebrospinal fluid must be conducted according to the diagnostic suspicion. Conclusion. The lumbar puncture in expert hands is a safe test. The health professional should be suitably familiar with its contraindications, the regional anatomy and the technique used to perform it

Respuesta de la cefalea en racimos crónica a la psilocibina / Chronic cluster headache: response to psilocybin

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