[Alzemon: a prospective follow-up study of eslicarbazepine acetate monotherapy in patients with newly diagnosed epilepsy]. / Alzemon: estudio de seguimiento prospectivo del acetato de eslicarbacepina en monoterapia en pacientes con epilepsia de diagnóstico reciente.

INTRODUCTION: Eslicarbazepine acetate is a novel sodium channel blocker for use in the treatment of focal onset seizures. Prospective studies on its effectiveness in monotherapy in patients with newly diagnosed partial epilepsy in routine clinical practice are scarce. AIM: To evaluate the effectiveness of eslicarbazepine as initial monotherapy in patients with newly diagnosed partial epilepsy in routine clinical practice. PATIENTS AND METHODS: A prospective, multicentre, post-authorisation study. Patients with newly diagnosed partial epilepsy aged 18 years or older without previous treatment were included. The efficacy variables were: percentage of seizure-free patients, responders and reduction in monthly frequency of seizures. The safety variables analyse the 12-month retention rate and the occurrence of adverse effects. RESULTS: Fifty-three patients were included. The retention rate was 77.4%. At the end of the observation period, 83% of patients were seizure-free and 92.5% had reduced their baseline frequency by 50% or more. In addition, 68% of the patients reported some adverse effect and 7.5% of them dropped out of the study for this reason. The effectiveness analysis of the subgroup of patients aged 65 years or more showed no differences with respect to the overall population. CONCLUSION: Eslicarbazepine monotherapy in patients with newly diagnosed partial epilepsy, both in the general population and in the population over 65 years old, is effective and safe in routine clinical practice.

TITLE: Alzemon: estudio de seguimiento prospectivo del acetato de eslicarbacepina en monoterapia en pacientes con epilepsia de diagnóstico reciente.Introducción. El acetato de eslicarbacepina es un nuevo bloqueante de los canales de sodio en el tratamiento de las crisis de inicio focal. Los estudios prospectivos sobre su efectividad en monoterapia en pacientes con epilepsia parcial de reciente diagnóstico en la práctica clínica habitual son escasos. Objetivo. Evaluar la efectividad de la eslicarbacepina en monoterapia de inicio en pacientes con epilepsia parcial de reciente diagnóstico en la práctica clínica habitual. Pacientes y métodos. Estudio postautorización prospectivo y multicéntrico. Se incluyó a pacientes con epilepsia parcial de reciente diagnóstico de 18 años o más sin tratamiento previo. Las variables de eficacia fueron: porcentaje de pacientes libres de crisis, respondedores y reducción en la frecuencia mensual de crisis. Las variables de seguridad analizan la tasa de retención a los 12 meses y la aparición de efectos adversos. Resultados. Se incluyó a 53 pacientes. La tasa de retención fue del 77,4%. Al final del período de observación, el 83% de los pacientes se encontraba libre de crisis y el 92,5% había reducido en un 50% o más su frecuencia basal. El 68% de los pacientes notificó algún efecto adverso y el 7,5% de ellos abandonó el estudio por este motivo. El análisis de efectividad del subgrupo de 65 años o más no mostró diferencias respecto a la población global. Conclusión. La eslicarbacepina en monoterapia en pacientes con epilepsia parcial de reciente diagnóstico, tanto en la población general como en la población de más de 65 años, es eficaz y segura en la práctica clínica habitual.

Alzemon: estudio de seguimiento prospectivo del acetato de eslicarbacepina en monoterapia en pacientes con epilepsia de diagnóstico reciente / Alzemon: a prospective follow-up study of eslicarbazepine acetate monotherapy in patients with newly diagnosed epilepsy

Introducción: El acetato de eslicarbacepina es un nuevo bloqueante de los canales de sodio en el tratamiento de las crisis de inicio focal. Los estudios prospectivos sobre su efectividad en monoterapia en pacientes con epilepsia parcia l de reciente diagnóstico en la práctica clínica habitual son escasos.Objetivo: Evaluar la efectividad de la eslicarbacepina en monoterapia de inicio en pacientes con epilepsia parcial de reciente diagnóstico en la práctica clínica habitual.Pacientes y métodos: Estudio postautorización prospectivo y multicéntrico. Se incluyó a pacientes con epilepsia parcial de reciente diagnóstico de 18 años o más sin tratamiento previo. Las variables de eficacia fueron: porcentaje de pacientes libres de crisis, respondedores y reducción en la frecuencia mensual de crisis. Las variables de seguridad analizan la tasa de retención a los 12 meses y la aparición de efectos adversos.Resultados: Se incluyó a 53 pacientes. La tasa de retención fue del 77,4%. Al final del período de observación, el 83% de los pacientes se encontraba libre de crisis y el 92,5% había reducido en un 50% o más su frecuencia basal. El 68% de los pacientes notificó algún efecto adverso y el 7,5% de ellos abandonó el estudio por este motivo. El análisis de efectividad del subgrupo de 65 años o más no mostró diferencias respecto a la población global.Conclusión: La eslicarbacepina en monoterapia en pacientes con epilepsia parcial de reciente diagnóstico, tanto en la población general como en la población de más de 65 años, es eficaz y segura en la práctica clínica habitual.(AU)

Introduction: Eslicarbazepine acetate is a novel sodium channel blocker for use in the treatment of focal onset seizures. Prospective studies on its effectiveness in monotherapy in patients with newly diagnosed partial epilepsy in routine clinical practice are scarce. Aim: To evaluate the effectiveness of eslicarbazepine as initial monotherapy in patients with newly diagnosed partial epilepsy in routine clinical practice. Patients and methods: A prospective, multicentre, post-authorisation study. Patients with newly diagnosed partial epilepsy aged 18 years or older without previous treatment were included. The efficacy variables were: percentage of seizure-free patients, responders and reduction in monthly frequency of seizures. The safety variables analyse the 12-month retention rate and the occurrence of adverse effects. Results: Fifty-three patients were included. The retention rate was 77.4%. At the end of the observation period, 83% of patients were seizure-free and 92.5% had reduced their baseline frequency by 50% or more. In addition, 68% of the patients reported some adverse effect and 7.5% of them dropped out of the study for this reason. The effectiveness analysis of the subgroup of patients aged 65 years or more showed no differences with respect to the overall population. Conclusion: Eslicarbazepine monotherapy in patients with newly diagnosed partial epilepsy, both in the general population and in the population over 65 years old, is effective and safe in routine clinical practice.(AU)

Estudio LAM: conducta y calidad de vida en pacientes diagnosticados de epilepsia tratados con lacosamida / LAM study: Effects of lacosamide on behaviour and quality of life in patients with epilepsy

Introducción: La comorbilidad psiquiátrica es común en epilepsia, de ahí la importancia de considerar en qué medida los fármacos antiepilépticos pueden influir en el estado de ánimo. El objetivo de este trabajo es analizar el efecto de lacosamida en la calidad de vida y en la conducta del paciente epiléptico en la práctica clínica. Métodos: Estudio multicéntrico, observacional y prospectivo en pacientes diagnosticados de epilepsia, mal controlados que recibieron tratamiento adyuvante con lacosamida. Mediante 4 visitas durante 12 meses se valoró el impacto del fármaco en la calidad de vida y el estado de ánimo utilizando el cuestionario de calidad de vida QOLIE-10, la escala hospitalaria de ansiedad y depresión (HADS) y la escala de impulsividad de Barratt (BIS-11), además se determinó su eficacia y seguridad. Resultados: Se incluyeron 55 pacientes, edad media 47,1 ± 18,4 años; porcentaje inicial de comorbilidad psiquiátrica 34,5% y número medio de crisis/mes previo 3,6 ± 4,3. Las escalas QOLIE-10 y HADS reflejaron mejoras estadísticamente significativas en pacientes que partían de una situación basal desfavorable (ansiedad, depresión y/o baja calidad de vida). La escala BIS-11 no detectó la aparición de conductas impulsivas durante el seguimiento. Tras 12 meses de tratamiento el 51,9% de los pacientes estuvo sin crisis, y un 77,8% presentó una educción ≥ 50%. La mayoría de efectos adversos fueron leves, obligando a retirar el fármaco en 10 casos (18,2%). Conclusiones: Lacosamida ofrece un perfil de eficacia y seguridad favorable, y podría constituir una opción terapéutica útil en pacientes con epilepsia y comorbilidad psiquiátrica

Introduction: Psychiatric comorbidities are common in epileptic patients, and evaluating the impact of antiepileptic drugs on patients’ moods is therefore essential. The aim of this study is to assess the effects of lacosamide on behaviour and quality of life in people with epilepsy. Methods: We conducted a multicentre prospective observational study of poorly-controlled epileptic patients who received lacosamide as an adjuvant treatment. Patients were evaluated on 4 occasions during a 12-month period. The impact of lacosamide on patients’ mood and quality of life was assessed with the Quality of Life in Epilepsy Inventory-10 (QOLIE-10), the Hospital Anxiety and Depression Scale (HADS), and the Barratt Impulsiveness Scale (BIS-11). As a secondary objective, we evaluated the effectiveness and safety of lacosamide. Results: We included 55 patients with a mean age of 47.1 ± 18.4 years. At baseline, 34.5% of the patients had psychiatric comorbidities; the mean number of crises in the previous month was 3.6 ± 4.3. The QOLIE-10 and HADS scales revealed statistically significant improvements in patients with a poor baseline condition (anxiety, depression, and/or poor quality of life). The BIS-11 scale detected no impulsive behaviour during follow-up. After 12 months of treatment, 51.9% of the patients were seizure-free and 77.8% experienced a reduction of at least 50% in seizure frequency. Adverse effects were mild in most cases; lacosamide was discontinued in 10 patients (18.2%)

LAM study: Effects of lacosamide on behaviour and quality of life in patients with epilepsy. / Estudio LAM: conducta y calidad de vida en pacientes diagnosticados de epilepsia tratados con lacosamida.

INTRODUCTION: Psychiatric comorbidities are common in epileptic patients, and evaluating the impact of antiepileptic drugs on patients' moods is therefore essential. The aim of this study is to assess the effects of lacosamide on behaviour and quality of life in people with epilepsy. METHODS: We conducted a multicentre prospective observational study of poorly-controlled epileptic patients who received lacosamide as an adjuvant treatment. Patients were evaluated on 4 occasions during a 12-month period. The impact of lacosamide on patients' mood and quality of life was assessed with the Quality of Life in Epilepsy Inventory-10 (QOLIE-10), the Hospital Anxiety and Depression Scale (HADS), and the Barratt Impulsiveness Scale (BIS-11). As a secondary objective, we evaluated the effectiveness and safety of lacosamide. RESULTS: We included 55 patients with a mean age of 47.1±18.4 years. At baseline, 34.5% of the patients had psychiatric comorbidities; the mean number of crises in the previous month was 3.6±4.3. The QOLIE-10 and HADS scales revealed statistically significant improvements in patients with a poor baseline condition (anxiety, depression, and/or poor quality of life). The BIS-11 scale detected no impulsive behaviour during follow-up. After 12 months of treatment, 51.9% of the patients were seizure-free and 77.8% experienced a reduction of at least 50% in seizure frequency. Adverse effects were mild in most cases; lacosamide was discontinued in 10 patients (18.2%). CONCLUSIONS: Lacosamide is a safe and effective treatment option for patients with epilepsy and psychiatric comorbidities.

Experiencia en el tratamiento de la neuropatía diabética dolorosa con acetato de eslicarbazepina / Experience with eslicarbazepine acetate as treatment for painful diabetic neuropathy

No disponible

[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.

Valor de la evaluación combinada de olfación e hiperecogenicidad de sustancia negra en el diagnóstico de la enfermedad de Parkinson / Diagnostic value of combined assessment of olfaction and sustantia nigra hyperechogenicity for Parkinson's disease

Introducción: La hiposmia y la hiperecogenicidad de la sustancia negra (SN+) son marcadores característicos de la enfermedad de Parkinson (EP), aunque su valor diagnóstico de forma aislada puede ser limitado. Se evalúa la prevalencia combinada de ambos marcadores en pacientes diagnosticados de enfermedad de Parkinson (EP) y su rentabilidad diagnóstica frente a una muestra con temblor esencial (TE) y otra de sujetos sanos. Métodos: Se incluyó a pacientes con diagnóstico de EP y TE procedentes de nuestra consulta externa. La olfación se evaluó con el test de identificación de olores Sniffin Sticks test (SS-12) y la evaluación de la sustancia negra mediante dúplex transcraneal. Resultados: Se evaluó a 98 individuos, 30 con diagnóstico de EP, 21 con TE y 47 controles. Las prevalencias de hiposmia (SS-12 < 8) e hiperecogenicidad de SN (área > 0,24 cm2) fueron del 70 y el 83,3% en EP, el 33,3 y el 9,5% en TE y el 17 y el 10,6% en los controles, respectivamente. La combinación de ambos marcadores estaba presente en el 63% de los pacientes con EP y en ninguno de los pacientes con TE y solo en 2 de los controles. Conclusiones: La evaluación combinada de la evaluación olfativa mediante el SS-12 y de la sustancia negra mediante ecografía, 2 test rápidos, inocuos y accesibles, mejora la especificidad aislada que cada marcador tiene en el diagnóstico de la EP frente a pacientes con TE o controles. Dado que ambos marcadores se han descrito en fases muy precoces de la EP, su aplicación podría ayudarnos en su diagnóstico precoz

Introduction: Hyposmia and substantia nigra hyperechogenicity (SN+) are characteristic markers of Parkinson's disease (PD), although their diagnostic value in isolation may be limited. We evaluated the combined prevalence of both disorders in patients diagnosed with PD and assessed their diagnostic yield compared to a sample with essential tremor (ET) and another group of healthy subjects. Methods: Patients diagnosed with PD and ET and treated in our outpatient clinic were enrolled. Olfaction was assessed using the 'Sniffin Sticks' odour identification test (SS-12) and hyperechogenicity of the substantia nigra (SN+) was assessed by transcranial duplex ultrasound. Results: A total of 98 subjects were analysed, comprising 30 with PD, 21 with ET, and 47 controls. The respective prevalence rates of hyposmia (SS-12 < 8) and SN+ (area > .24 cm2) were 70% and 83.3% in PD, 33.3% and 9.5% in ET, and 17% and 10.6% in controls. Both markers were present in 63% of patients with PD, none of the patients with ET, and only 2 of the controls. Conclusions: Combined use of substantia nigra sonography and olfactory testing with SS-12, two rapid, safe, and accessible tests, was more specific than each isolated marker for distinguishing patients with PD from patients with ET and control subjects. Since both markers have been described in very early phases of PD, combined use may be helpful in providing early diagnosis of PD

Diagnostic value of combined assessment of olfaction and sustantia nigra hyperechogenicity for Parkinson's disease.

INTRODUCTION: Hyposmia and substantia nigra hyperechogenicity (SN+) are characteristic markers of Parkinson's disease (PD), although their diagnostic value in isolation may be limited. We evaluated the combined prevalence of both disorders in patients diagnosed with PD and assessed their diagnostic yield compared to a sample with essential tremor (ET) and another group of healthy subjects. METHODS: Patients diagnosed with PD and ET and treated in our outpatient clinic were enrolled. Olfaction was assessed using the "Sniffin' Sticks" odour identification test (SS-12) and hyperechogenicity of the substantia nigra (SN+) was assessed by transcranial duplex ultrasound. RESULTS: A total of 98 subjects were analysed, comprising 30 with PD, 21 with ET, and 47 controls. The respective prevalence rates of hyposmia (SS-12 < 8) and SN+ (area > .24cm(2)) were 70% and 83.3% in PD, 33.3% and 9.5% in ET, and 17% and 10.6% in controls. Both markers were present in 63% of patients with PD, none of the patients with ET, and only 2 of the controls. CONCLUSIONS: Combined use of substantia nigra sonography and olfactory testing with SS-12, two rapid, safe, and accessible tests, was more specific than each isolated marker for distinguishing patients with PD from patients with ET and control subjects. Since both markers have been described in very early phases of PD, combined use may be helpful in providing early diagnosis of PD.

Applicability of evidence-based practice in public health: risk assessment on Q fever under an ongoing outbreak.

With reference to the Q fever outbreak in the Netherlands in 2009-10, we tested if an evidence-based approach, comparable to the methodology used in clinical medicine, was appropriate for giving public health advice under time constrains. According to the principles of evidence-based methodologies, articles were retrieved from bibliographic databases and categorised by type and size, outcome, strengths and limitations. The risk assessment was conducted in two months and involved six staff members. We retrieved and read 559 abstracts and selected approximately 150 full text articles. The most striking finding was the lack of sound scientific evidence behind standard treatment regimes for Q fever in pregnancy. Difficulties in applying existing evidence rating systems and in expressing uncertainties were identified as problems during the process. By systematically assessing the evidence on several questions about Q fever, we were able to draw new conclusions and specify earlier statements. We found it difficult to grade the mostly observational studies with the known evidence-based grading systems. There is need to develop new methods for grading evidence from different sources in the field of public health. We conclude that an evidence-based approach is feasible for providing a risk assessment within two to three months.

Calidad en la conservación de los medicamentos termolábiles en el ámbito domiciliario / Quality of storage of thermolabile drugs in patients’ homes

ObjetivoEvaluar las condiciones de conservación en el domicilio del paciente de 2 medicamentos termolábiles, el etanercept (Enbrel®) y el adalimumab (Humira®), y establecer la posible influencia sobre la temperatura (Ta) media de conservación de variables como el número de personas que viven en el domicilio, la edad de los pacientes o la antigüedad de la nevera.Material y métodosEstudio observacional prospectivo. La muestra estuvo constituida por 60 pacientes en tratamiento con Enbrel® o Humira®. Se utilizaron tarjetas con un sensor térmico integrado, VarioSens®, que se colocaron sobre el embalaje externo del medicamento, programadas para registrar la Ta cada 90min, durante aproximadamente 30 días. Se empleó como variable principal la Ta media de conservación detectada en los frigoríficos.ResultadosLos resultados confirmaron que existe mayor riesgo de conservación inadecuada mantenida (más de 24h consecutivas) cuando la Ta media del frigorífico está fuera del rango 2–8°C (riesgo relativo=3,9; intervalo de confianza del 95%=1,95–7,93; p<0,0001). Treinta y cinco pacientes (58,3%) tenían el medicamento a una Ta media fuera del rango establecido. Se observaron diferencias significativas en la Ta media de conservación en función de la antigüedad del frigorífico, inferior o superior a 5 años (p=0,029). La antigüedad superior a 5 años supuso un factor de riesgo para una conservación inadecuada (riesgo relativo=1,68; intervalo de confianza al 95%=1,04–2,71), con p=0,023 en la prueba de la Ji al cuadrado de Pearson.ConclusionesEs necesario establecer procedimientos que garanticen la trazabilidad de las condiciones de conservación de los medicamentos termolábiles a nivel domiciliario. Las nuevas tecnologías lo permiten, facilitan el asesoramiento al paciente y la toma de decisiones en cuanto a dispensación y reutilización en caso de devolución, y mejoran así nuestra calidad asistencial(AU)

ObjectiveTo evaluate storage conditions of two thermolabile drugs, etanercept and adalimumab, in patients’ homes, and the possible influence over the average storage temperature of variables such as the number of people living at home, age of the patient or age of the refrigerator.Materials and methodsProspective observational study. The sample consisted of 60 patients treated with Enbrel® or Humira®. Data loggers cards were used, with an integrated thermal sensor VarioSens®, which were placed on the outer packaging of the product, programmed to record temperatures every 90min for approximately 30 days. The average storage temperature recorded in refrigerators was used as the main variable.ResultsIt was shown that there is a greater risk of not maintaining adequate storage when the mean temperature of the refrigerator is outside a range of 2–8°C, RR=3.9 (95% CI=1.95–7.93), P=0.0001. A total of 35 patients (58.3%) stored medicines outside the correct temperature range. There were significant differences in average storage temperatures depending on the whether the age of the refrigerator was greater or less than 5 years, P=0.029. Older than 5 years represents a risk factor for inadequate storage, RR=1.68 (95% CI=1.04–2.71), P=0.023 with the Pearson chi-squared test.ConclusionsProcedures need to be established to ensure traceability of the storage of heat-labile drugs in patients’ homes. New technologies allow this to be done, by providing advice to patients and for making decisions regarding dispensing and reuse in the event of return, thus improving our quality of care(AU)

[Quality of storage of thermolabile drugs in patients' homes]. / Calidad en la conservación de los medicamentos termolábiles en el ámbito domiciliario.

OBJECTIVE: To evaluate storage conditions of two thermolabile drugs, etanercept and adalimumab, in patients' homes, and the possible influence over the average storage temperature of variables such as the number of people living at home, age of the patient or age of the refrigerator. MATERIALS AND METHODS: Prospective observational study. The sample consisted of 60 patients treated with Enbrel or Humira. Data loggers cards were used, with an integrated thermal sensor VarioSens, which were placed on the outer packaging of the product, programmed to record temperatures every 90 min for approximately 30 days. The average storage temperature recorded in refrigerators was used as the main variable. RESULTS: It was shown that there is a greater risk of not maintaining adequate storage when the mean temperature of the refrigerator is outside a range of 2-8 degrees C, RR = 3.9 (95% CI = 1.95-7.93), P = 0.0001. A total of 35 patients (58.3%) stored medicines outside the correct temperature range. There were significant differences in average storage temperatures depending on the whether the age of the refrigerator was greater or less than 5 years, P = 0.029. Older than 5 years represents a risk factor for inadequate storage, RR = 1.68 (95% CI = 1.04-2.71), P = 0.023 with the Pearson chi-squared test. CONCLUSIONS: Procedures need to be established to ensure traceability of the storage of heat-labile drugs in patients' homes. New technologies allow this to be done, by providing advice to patients and for making decisions regarding dispensing and reuse in the event of return, thus improving our quality of care.

La cadena del frío de los medicamentostermolábiles en el domicilio del paciente / Cold chain for the storage of heat-labile drugs in the home

Objetivo: Valorar, de forma preliminar, las condiciones de conservación de los medicamentos termolábiles dispensados a pacientes externos, con el fin de ampliar el control de la cadena de frío al ámbito domiciliario. Métodos: El Servicio de Farmacia ofrece a los pacientes la posibilidad de validar la capacidad de la correcta conservación domiciliaria de los medicamentos termolábiles que le son dispensados. El procedimiento permite registrar la temperatura de conservación durante el transporte y en el frigorífico del paciente. A tal fin se utilizan tarjetas registradoras VarioSens(R), que se colocan en la parte externa del material de acondicionamiento del medicamento y que son programadas para hacer registros de temperatura cada 10 minutos, si ésta se encuentra fuera del rango 2-8 ºC. Resultados: En ninguno de los casos (n= 36) se mantuvo la temperatura dentro del rango establecido durante todo el periodo registrado. La temperatura media durante el transporte fue de 21,3 ± 7,0 ºC, alcanzándose más de 25 ºC en el 50% de los casos. La temperatura media de las neveras fue de 8,4 ± 3,7 ºC. En 18 casos sus temperaturas medias estaban dentro del intervalo establecido, en 16 por encima de 8 ºC y en 2 casos estuvieron por debajo de 2 ºC. Conclusiones: Los resultados obtenidos indican que hay que desarrollar medidas para mejorar las condiciones de conservación de los medicamentos termolábiles en el domicilio de los pacientes ambulatorios, para poder garantizar la efectividad terapéutica de éstos. Las nuevas tecnologías permiten ampliar el control de la cadena del frío hasta la administración del medicamento (AU)

Objective: A preliminary evaluation of the conditions in which the heat-labile drugs provided to outpatients are stored, in the attempt to extend the control of the cold chain to the home setting. Methods: The Pharmacy Service offers patients the possibility of validating the proper storage of the heat-labile drugs provided to them in their homes. The procedure makes it possible to record the storage temperature during transport and in the patient's refrigerator at home. This is achieved using VarioSens(R) data loggers, placed on the outer surface of the packaging of the medication. These recording cards were programmed to measure the temperature every 10 minutes if it was outside the range of 2 to 8 ºC. Results: In no case (n= 36) was the temperature maintained with in the established range for the entire recording period. The mean temperature during transport was 21.3 ± 7.0 ºC, with temperatures of over 25 ºC in 50% of the cases. The mean temperature of the refrigerators was 8.4 ± 3.7 ºC. In 18 cases, the mean temperatures were within the established range, in16 cases, they were over 8 ºC and in two cases, they were under 2 ºC. Conclusions: The results obtained indicate that measures must be introduced to improve the storage conditions of heat-labile drugs in the homes of outpatients in order to ensure their therapeutic efficacy. New technologies make it possible to control the cold chain until the medication is administered (AU)

[Massive cerebral infarction secondary to apoplexy due to pituitary adenoma]. / Infarto cerebral masivo secundario a apoplejía de un adenoma hipofisario.

INTRODUCTION: Pituitary apoplexy is a rare clinical entity. It is a rare cause of stroke, whose pathogenic mechanism has not been fully understood. Compression in intracavernous carotid artery and vasospastic mechanism have been described. It may initially begin as a meningeal syndrome, in which neuroimaging techniques may be fundamental, above all resonance magnetic imaging for a correct diagnosis of the disease and its complications. CASE REPORT: We report the case of a 23 year-old male who suffered a massive stroke due to bilateral carotid compression in its intracavernous portion due to apoplexy of a previously unknown pituitary tumor. The diffusion sequences and acute angioresonance of the circle of Willis are presented. CONCLUSIONS: This is a rare entity with controversial management. An exhaustive review of cases and series of patients with pituitary apoplexy related stroke is also presented.

[The use of levetiracetam in monotherapy in post-stroke seizures in the elderly population]. / Uso del levetiracetam en monoterapia en crisis postictus de la población anciana.

INTRODUCTION: Strokes are the leading cause of epileptic seizures in adults and account for 50% of seizures in those over the age of 65. These patients present certain specific characteristics with respect to the remaining population, which makes it necessary to look for medication that are suited to their particular case. AIM: To describe the effectiveness and safety of levetiracetam (LEV) in monotherapy in elderly patients with post-stroke epileptic seizures. PATIENTS AND METHODS: A prospective evaluation was conducted of a series of cases consisting of patients over the age of 60 years who had suffered a stroke and had had at least one epileptic seizure in the late post-stroke phase (more than two weeks). Demographic data and the characteristics of the epilepsy and the stroke were collected. Patients began treatment with LEV in monotherapy, underwent check-ups at one and six months of treatment, and the effectiveness and safety of the drug were evaluated. RESULTS: The sample consisted of 25 patients with a mean age of 75.2 +/- 7.6 years. They presented an average of 3.2 +/- 5.6 post-stroke seizures and the time elapsed since the stroke was 38.3 +/- 81.8 months. After six months' follow-up, 76% of the patients were still receiving treatment with LEV. Of the patients under treatment, 89.5% were free from seizures. Side effects that could be attributed to LEV were noted by 28% of patients, but did not compel them to stop treatment. CONCLUSIONS: LEV in monotherapy can be a safe, effective therapeutic option for elderly patients who have presented epilepsy following a stroke.

Uso del levetiracetam en monoterapia en crisis postictus de la población anciana / The use of levetiracetam in monotherapy in post-stroke seizures in the elderly population

Los ictus son la primera causa de crisis epilépticas en adultos y los responsables del 50% de crisisen mayores de 65 años. Estos pacientes presentan unas características propias respecto al resto de la población, por lo que se hace necesario buscar fármacos que resulten apropiados. Objetivo. Describir la eficacia y tolerabilidad del levetiracetam(LEV) en monoterapia en pacientes ancianos con crisis epilépticas postictus. Pacientes y métodos. Se evaluó prospectivamente una serie de casos formada por pacientes mayores de 60 años que hubieran sufrido un ictus y presentaran, al menos, una crisis epiléptica en la fase tardía (más de dos semanas) postictus. Se recabaron datos demográficos, características de la epilepsia y del ictus. Los pacientes iniciaron tratamiento con LEV en monoterapia, fueron controlados al mes y a los seis meses de tratamiento, y se evaluó la eficacia y tolerabilidad del fármaco. Resultados. Se incluyeron 25 pacientes con edad media de75,2 ± 7,6 años. Presentaron una media de 3,2 ± 5,6 crisis postictus y un tiempo trascurrido desde el ictus de 38,3 ± 81,8 meses.Tras seis meses de seguimiento, el 76% de los enfermos continuaba tratamiento con LEV. De los pacientes con el tratamiento, el 89,5% se mantenía libre de crisis. El 28% había presentado algún efecto secundario atribuible al LEV que no obligó a la suspensión del tratamiento. Conclusión. El LEV en monoterapia puede ser una opción terapéutica eficaz y segura para aquellos pacientes ancianos que hubieran presentado epilepsia tras sufrir un ictus

Strokes are the leading cause of epileptic seizures in adults and account for 50% of seizures in thoseover the age of 65. These patients present certain specific characteristics with respect to the remaining population, which makes it necessary to look for medication that are suited to their particular case. Aim. To describe the effectiveness and safetyof levetiracetam (LEV) in monotherapy in elderly patients with post-stroke epileptic seizures. Patients and methods. A prospective evaluation was conducted of a series of cases consisting of patients over the age of 60 years who had suffered a stroke and had had at least one epileptic seizure in the late post-stroke phase (more than two weeks). Demographic data andthe characteristics of the epilepsy and the stroke were collected. Patients began treatment with LEV in monotherapy, underwent check-ups at one and six months of treatment, and the effectiveness and safety of the drug were evaluated. Results. The sample consisted of 25 patients with a mean age of 75.2 ± 7.6 years. They presented an average of 3.2 ± 5.6 post-strokeseizures and the time elapsed since the stroke was 38.3 ± 81.8 months. After six months’ follow-up, 76% of the patients were still receiving treatment with LEV. Of the patients under treatment, 89.5% were free from seizures. Side effects that could be attributed to LEV were noted by 28% of patients, but did not compel them to stop treatment. Conclusions. LEV in monotherapycan be a safe, effective therapeutic option for elderly patients who have presented epilepsy following a stroke

[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%.

Estudio del diámetro del ventrículo III mediante dúplex transcraneal / Study of the diameter of the third ventricle with transcranial sonography

Introducción. La insonación transtemporal mediante sistemas de ultrasonidos dúplex transcraneal codificado en color (DTCC) con sondas de baja frecuencia (2-2,5 MHz) permite la evaluación no sólo de los vasos del polígono de Willis, sino también de estructuras parenquimatosas cerebrales. Un número reducido de estudios, ninguno en nuestro medio, ha evidenciando su utilidad para la evaluación del sistema ventricular en adultos. Objetivo. Evaluar la utilidad del dúplex transcraneal como técnica de medición del diámetro del ventrículo III en una muestra de pacientes con enfermedades neurológicas. Pacientes y métodos. Se seleccionaron pacientes de cualquier edad ingresados en nuestro servicio de neurología y a los que dentro del protocolo de estudio se solicitaba una resonancia magnética (RM) encefálica. El máximo diámetro del ventrículo III se medía mediante DTCC y RM en planos axiales. Se presentan los resultados obtenidos mediante cada técnica y la correlación lineal entre ambas mediciones. Resultados. Se han estudiado 30 pacientes con una edad media de 48,5 años y 66,6% de mujeres. El diámetro del ventrículo III (media±desviación estándar) fue de 3,97± 2,58 mm medido con el DTCC y de 3,70±2,27 mm con la RM. La correlación lineal entre los valores obtenidos por ambas técnicas fue elevada (r=0,85). Conclusiones. Con el dúplex transcraneal disponemos de una técnica económica, inocua y de fácil aplicación que obtiene resultados equiparables a la RM en la determinación del tamaño del ventrículo III

Introduction. Transtemporal insonation by means of transcranial color-coded duplex sonography (TCDS) with low frequency probes (2-2.5 MHz) makes it possible to not only evaluate the blood vessels of the circle of Willis but also of brain parenchymal structures. A reduced number of studies, none of them in our area, have reported its usefulness for the evaluation of the ventricular system in adults. Aim. To evaluate ability of the transcranial duplex to measure the third ventricle diameter in a sample of patients with different neurological illnesses. Patients and methods. Patients of all ages admitted to our neurology ward and whose diagnostic procedure included a brain magnetic resonance (MRI) were recruited. The largest third ventricle diameter was measured with both the TCDS and MRI in axial planes. We report the results observed with both techniques and the lineal correlation between both of them. Results. We included 30 patients with mean age 48.5 years and 66.6% females. The third ventricle diameter (average ± standard deviation) was 3.97 ± 2.58 mm as measured with TCDS and 3.70±2.27 mm on MRI. Linear correlation between the values observed was high (r=0.85). Conclusions. Transcranial duplex is a cheap, safe and easy to perform technique. It has similar results in comparison with those obtained with the MRI when the third ventricle size is measured

[Study of the diameter of the third ventricle with transcranial sonography]. / Estudio del diámetro del ventrículo III mediante dúplex transcraneal.

INTRODUCTION: Transtemporal insonation by means of transcranial color-coded duplex sonography (TCDS) with low frequency probes (2-2.5 MHz) makes it possible to not only evaluate the blood vessels of the circle of Willis but also of brain parenchymal structures. A reduced number of studies, none of them in our area, have reported its usefulness for the evaluation of the ventricular system in adults. Aim. To evaluate ability of the transcranial duplex to measure the third ventricle diameter in a sample of patients with different neurological illnesses. PATIENTS AND METHODS: Patients of all ages admitted to our neurology ward and whose diagnostic procedure included a brain magnetic resonance (MRI) were recruited. The largest third ventricle diameter was measured with both the TCDS and MRI in axial planes. We report the results observed with both techniques and the lineal correlation between both of them. RESULTS: We included 30 patients with mean age 48.5 years and 66.6% females. The third ventricle diameter (average +/- standard deviation) was 3.97 +/- 2.58 mm as measured with TCDS and 3.70 +/- 2.27 mm on MRI. Linear correlation between the values observed was high (r=0.85). CONCLUSIONS: Transcranial duplex is a cheap, safe and easy to perform technique. It has similar results in comparison with those obtained with the MRI when the third ventricle size is measured.

[Estimation of incidence and analysis of sepsis in an area of Valencia (Spain)]. / Incidencia estimada y análisis de la sepsis en un área de Valencia.

OBJECTIVES: To study the incidence of sepsis in an area of Valencia, as well as its characteristics, and to evaluate short-term outcomes. PATIENTS AND METHODS: An active surveillance program was carried out to determine the incidence and characteristics of sepsis. All patients attending the Hospital de La Ribera from January 1999 to December 2004 were included. Incidence rates were calculated and logistic regression analysis was performed. RESULTS: The incidence rate was 60.9 per 100,000 person-years. The incidence was highest among children younger than 1 year (1,138 per 100,000 person-years). A total of 14.4 % of cases were nosocomial infections. The most common microorganisms found were Escherichia coli, Streptococcus pneumoniae and Neisseria meningitidis. Microbiologically undocumented sepsis accounted for 32 % of the cases. The case-fatality rate was 1.3 %. Seventeen patients (11.1 %) were transferred to an intensive care unit (ICU). The risk of being transferred to an ICU was 14 times higher in patients with meningitis than in those with other sources of infection, independently of age and microbiological characteristics (OR 13.9, 95 % CI 2.6-75.3, P = 0.002). CONCLUSIONS: The incidence rate of sepsis is high in the pediatric age group. Clinical sepsis represented an important percentage of pediatric sepsis in our center. The main factor associated with patient transfer to the ICU was the central nervous system as the source of sepsis.