Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: The FYDATA study.

BACKGROUND: Real-world data of current antiepileptic drugs (AEDs) used to treat focal seizures is of importance to understand the efficacy and safety outside of the clinical trial setting. Here we report real-world data from a large series of patients treated with perampanel for 1year. METHODS: FYDATA was a multicentre, retrospective, 1-year observational study assessing the efficacy and safety of adjuvant perampanel in patients ≥12 years of age with focal epilepsy in a real-world setting. At 12 months, the proportion of patients who were seizure free, median percentage seizure reduction, proportion of responders, retention rate and proportion of patients with adverse events (AEs) were assessed. Analyses were also performed to identify any patient-, medication- and disease-related factors associated with a large clinical response or carry a risk for AEs. RESULTS: A total of 464 patients were included in the study with a retention rate of 60.6% at 1year. The mean number of prior AEDs was 7.8. The median percentage reduction in overall seizures was 33.3% (75% for secondary generalised seizures) after 1year, with 7.2% of patients achieving seizure freedom. Furthermore, patients on non-enzyme-inducing AEDs were more likely to achieve seizure freedom, and logistic regression revealed that patients aged ≥65 years, those with epilepsy due to a vascular aetiology and those who had received fewer prior AEDs showed a better clinical response to perampanel. A total of 62.9% of the patients experienced AEs at 12 months; dizziness, somnolence and irritability were the most frequent AEs. Patients with prior psychiatric comorbidities (hyperactivity and personality disorder) were more likely to experience psychiatric AEs with perampanel, and slower titration schedules were associated with less AEs overall. CONCLUSION: Perampanel, for the treatment of focal epilepsy in a real-world setting in a refractory population, over 1year, demonstrates a similar efficacy and safety profile to that observed in clinical trials. Our results have implications for the optimisation of perampanel use in a clinical setting.

Nutritional status assessment in geriatrics: Consensus declaration by the Spanish Society of Geriatrics and Gerontology Nutrition Work Group.

Ongoing population ageing is one of the factors influencing the increase in the prevalence of undernutrition, because elderly people are a vulnerable group due to their biological, psychological and social characteristics. Despite its high prevalence, undernutrition is underdiagnosed in the geriatric sphere. For this reason, the aim of this consensus document is to devise a protocol for geriatric nutritional assessment. A multidisciplinary team has been set up within the Spanish Society of Geriatrics and Gerontology (in Spanish Sociedad Española de Geriatría y Gerontología, SEGG) in order to address undernutrition and risk of undernutrition so that they can be diagnosed and treated in an effective manner. The MNA-SF is a practical tool amongst the many validated methods for nutritional screening. Following suspicion of undernutrition or after establishing the presence of undernutrition, a full assessment will include a detailed nutritional history of the patient. The compilation of clinical-nutritional and dietetic histories seeks to aid in identifying the possible risk factors at the root of a patient's undernutrition. Following this, an anthropometric assessment associated to laboratory data, will describe the patient's physical and metabolic changes associated to undernutrition. Currently, the tendency is to further nutritional assessment through the use of non-invasive techniques to study body composition in association with functional status. The latter is an indirect index for nutritional status which is very interesting from a geriatrician's point of view. To conclude, correct nutritional screening is the fundamental basis for an early undernutrition diagnosis and to assess the need for nutritional treatment. In order to achieve this, it is fundamental to foster research in the field of nutritional geriatrics, in order to expand our knowledge base and to increasingly practice evidence-based geriatrics.

Nutritional status in a multicenter study among institutionalized patients in Spain.

INTRODUCTION: The aim of our study was to investigate and evaluate, in a multicenter study, the prevalence of malnutrition as well as the relationship between different anthropometric and biochemical markers with Mininutritional assessment (MNA) scores. SUBJECTS AND METHODS: A representative sample of the institutionalized Spanish population aged 65 and older (stricly speaking, born in 1942 or earlier), is covered in this cross-sectional survey. Anthropometric variables, MNA test and biochemical evaluation were performed by Geriatrics Units specialists. RESULTS: The percentage of patients classified as well nourished (27.8%) was larger in the 85-94 (39.4%) range than in the 65-74 (26.2%), 75-84 (24%) and > 95 (14.8%) age ranges. A population of 254 patients (49.6%) were at risk of undernutrition, a number which was larger in 75-84 (52%), 65-74 (53.8%) and > 95 (53.7%) than in the 85-94 (44.1%) ones. On the other hand, undernourishment (22.5%) was larger in those of 95 and older (31.5%) than in 85-94 (16.5%), 75-84 (24%) and 65-74 (20%) patients. According to our investigation females are worse nourished (Odd's Ratio 0.51 CI 95%: 0.33-0.79) and, consequently, more undernourished (Odd's Ratio 2.36 CI 95%: 1.48-3.74) than males. No significant differences in the "at risk of undernutrition category" (Odd's Ratio 0.76 CI 95%: 0.52-1.10) were observed but, in transferrin, iron, haemoglobin and total cholesterol, statistical differences among MNA classification were detected. MNA scores were correlated with iron, total cholesterol, albumin, transferrin, age and haemoglobin. CONCLUSION: In this multicenter study, institutionalized patients have a high prevalence of undernutrition or are at-risk, as well as females are more undernourished than males.

Evaluation of the mini-nutritional assessment short-form (MNA-SF) among institutionalized older patients in Spain.

INTRODUCTION: In the present study, we evaluated a short form version of MNA test in a multicenter study and the relationship of different biochemical markers with MNASF scores. MATERIAL AND METHODS: This was a cross-sectional survey covering a sample of representative of the older institutionalized Spanish population aged above 65 years (n = 873). A Mini nutritional assessment short form test (MNA-SF) was used. RESULTS: The number of patients classified as well nourished (42.1%) was larger in the 65-74 (52.6%) range than in the 75-84 (40.2%), 85-94 (43.8%) and > 95 (24%) age ranges. Risk of undernutrition occurred in a total of 506 patients (57.9%), risk of undernutrition was larger in > 95 (76%) range than in 65-74 (47.4%), 75-84 (59.8%) and 85-94 range (56.2%). No differences were detected between males and females at risk of undernutrition (odds ratio: 0.85 CI 95%: 0.64-1.12). CONCLUSION: In this multicenter study, institutionalized patients have a high prevalence of at risk of malnutrition assessed by MNA-SF test.

[Assessment of the efficiency of the clinical management of neuropathic pain in specialist clinics compared to general clinics in neurology health care units in Spain]. / Evaluación de la eficiencia del manejo clínico del dolor neuropático en consultas especializadas frente a consultas generales en unidades asistenciales de neurología en España.

OBJECTIVES: To analyse the cost-consequences of chronic neuropathic pain (NeP) outpatients care comparing management in general clinics (GC) versus specialised pain clinics (SPC) in neurology settings in Spain. METHODS: A 6-month retrospective, cross-sectional, comparative observational study including NeP subjects was designed. Sociodemographics and clinical characteristics of subjects along with pain-related healthcare and non healthcare resources utilization were recorded. Lost-work-days equivalent missed as a consequence of pain were also collected to compute indirect costs. Costs to society were calculated in euros for the year 2008. Severity and interference of pain were used for the main effectiveness evaluation. RESULTS: A total of 234 patients (53% in SPC), 56.8% women, and 59.3+/-14.7 years were included. Patients were allocated according to usual administrative procedures in each participant centre, consecutively and independently of the diagnosis and clinical status of patients. Yearly indirect costs were euro1,299+/-2,804 in SPC compared to euro1,483+/-3,452 in GC (p=0.660), while annual direct costs were, euro2,911+/-3,335 and euro3,563+/-4,797, respectively (p=0.239), with total costs of euro4,210+/-4,654 and euro5,060+/-6,250, respectively (p=0.249). Mean pain severity at the time of evaluation was 3.8+/-2.3 in subjects in SPC vs. 5.2+/-2 in GC (p<0.001), while the average interference of pain on daily activities were 3.3+/-2 and 4.7+/-2.5, respectively (p<0.001). CONCLUSIONS: In neurology settings in Spain, the outpatient clinical management of chronic NeP in SPC was a dominant alternative compared with GC healthcare, since it has shown better patients healthcare outcomes with less severity and interference of pain on daily activities, while maintaining a similar level of costs. These results could help health decision makers when planning the use of health care resources.

Evaluación de la eficiencia del manejo clínico del dolor neuropático en consultas especializadas frente a consultas generales en unidades asistenciales de neurología en España / Assessment of the efficiency of the clinical management of neuropathic pain in specialist clinics compared to general clinics in neurology health care Units in Spain

Objetivo: Evaluar la eficiencia del seguimiento clínico del dolor crónico neuropático (DN) en consultas especializadas (CE) frente a consultas generales (CG) en unidades asistenciales de neurología (UAN) en España. Métodos: Estudio transversal y retrospectivo, de 6 meses, observacional y comparativo, que incluyó a pacientes con DN. Se recogió: situación laboral, nivel educativo, historia clínica, comorbilidad concomitante, capacidad funcional y utilización de recursos sanitarios y no sanitarios. Los costes indirectos incluyeron los equivalentes de días de trabajo perdidos como consecuencia del DN. El coste se computó desde la perspectiva de la sociedad en el año 2008. Como medida de efectividad primaria se registraron la intensidad y la interferencia del dolor en las actividades de la vida diaria.Resultados: Se incluyó a 234 pacientes (el 53% en CE); el 56,8% eran mujeres, y la media de edad era 59,3±14,7 años. La asignación de pacientes se realizó según criterios asistenciales de forma consecutiva e independiente del diagnóstico y el estado clínico del paciente. El coste indirecto anual de los pacientes en CE fue de 1.299±2.804 euros frente a 1.483±3.452 euros en CG (p=0,660), mientras que los costes directos fueron, respectivamente, 2.911±3.335 euros y 3.563±4.797 euros (p=0,239), con unos costes totales de 4.210±4.654 euros y 5.060±6.250 euros (p=0,249). La puntuación media en la intensidad del dolor fue de 3,8±2,3 en CE y 5,2±2 en CG (p<0,001), mientras que la interferencia del dolor con las actividades diarias fue, respectivamente, de 3,3±2 y 4,7±2,5 (p<0,001). Conclusiones: El seguimiento clínico del DN en CE es una alternativa dominante cuando se compara con las CG en UAN en España, al asociarse a mejores resultados clínicos con menor intensidad del dolor e interferencia con las actividades diarias mientras se mantiene un coste similar (AU)

Objectives: To analyse the cost-consequences of chronic neuropathic pain (NeP) outpatients care comparing management in general clinics (GC) versus specialised pain clinics (SPC) in neurology settings in Spain.Methods: A 6-month retrospective, cross-sectional, comparative observational study including NeP subjects was designed. Sociodemographics and clinical characteristics of subjects along with pain-related healthcare and non healthcare resources utilization were recorded. Lost-work-days equivalent missed as a consequence of pain were also collected to compute indirect costs. Costs to society were calculated in euros for the year 2008. Severity and interference of pain were used for the main effectiveness evaluation.Results: A total of 234 patients (53% in SPC), 56.8% women, and 59.3±14.7 years were included. Patients were allocated according to usual administrative procedures in each participant centre, consecutively and independently of the diagnosis and clinical status of patients. Yearly indirect costs were €1,299±2,804 in SPC compared to €1,483±3,452 in GC (p=0.660), while annual direct costs were, €2,911±3,335 and €3,563±4,797, respectively (p=0.239), with total costs of €4,210±4,654 and €5,060±6,250, respectively (p=0.249). Mean pain severity at the time of evaluation was 3.8±2.3 in subjects in SPC vs. 5.2±2 in GC (p<0.001), while the average interference of pain on daily activities were 3.3±2 and 4.7±2.5, respectively (p<0.001).Conclusions: In neurology settings in Spain, the outpatient clinical management of chronic NeP in SPC was a dominant alternative compared with GC healthcare, since it has shown better patients healthcare outcomes with less severity and interference of pain on daily activities, while maintaining a similar level of costs. These results could help health decision makers when planning the use of health care resources (AU)

Prevalence of metabolic syndrome with International Diabetes Federation Criteria and ATP III Program in patients 65 years of age or older.

BACKGROUND: The relationship between cardiovascular factors and death can vary with age, very few studies have examined metabolic syndrome in the elderly. OBJECTIVE: The aim of this study is to assess the prevalence of the MS in a sample of elderly institutionalized patients (> 65 years) using ATPIII and IDF definitions. DESIGN: This was a cross-sectional survey covering a sample of representative of the institutionalized Spanish population aged above 65 years. The final sample study consisted of 862 patients, 556 females and 306 males. ATPIII and IDF definitions were used to classify the patients. RESULTS: Prevalence of MS was different according to the two definitions used. When the IDF definition was applied, total prevalence was 48.91% (CI 95%:43.47-50.25), while prevalence according to ATPIII criteria was 46.80% (CI = 43.47-50.25). a higher prevalence of MS was found in females as compared to males. Using IDF criteria, odds ratio was 1.9 (CI 95%:1.4-2.6) and 1.7 (CI 95%:1.2-2.2) according to ATPIII criteria. a steady decrease is seen in MS prevalence as the age of patients increases (the last two groups (85-94 ys and > 95 ys), both for the ATP III and the IDF definitions. CONCLUSION: A higher prevalence of MS in this elderly population as compared to general population was observed. A decrease of this prevalence above 95 years was detected.

[Prevalence of dementia in institutionalized patients. The RESYDEM study]. / Prevalencia de demencia en pacientes institucionalizados: estudio RESYDEM.

INTRODUCTION: To determine the prevalence of dementia in nursing homes in Spain and to analyze the associated factors in an elderly population in the institutional setting. MATERIAL AND METHODS: We performed a multicenter, cross-sectional, observational study of 852 residents of public, private and state-assisted nursing homes throughout Spain. Dementia was diagnosed according to the DSM-IV-TR clinical criteria. The Hughes Clinical Dementia Rating scale was used to measure global impairment or the global severity of dementia. Sociodemographic, clinical and neuropsychological variables, together with the pharmacological treatments prescribed to the participants, were recorded. RESULTS: The overall prevalence of dementia was 61.7% (95% CI 58.4-65.1) and that of Alzheimer's disease was 16.9% (95% CI 14.3-19.5). Vascular dementia was found in 7.3% (95% CI 5.5-9.1). Female sex was independently associated with a greater frequency of dementia. The prevalence of dementia increased with age. Only 18.8% (95% CI 15.4-22.3) of the patients diagnosed with dementia received specific treatment for the disorder. CONCLUSIONS: Two-thirds of the elderly persons living in nursing homes in Spain have dementia. Undertreatment of this disease is common. Increased awareness among health care professionals is important for the early diagnosis and appropriate management of dementia, which would represent a radical change in the approach to this disease.

Prevalencia de demencia en pacientes institucionalizados: estudio RESYDEM / Prevalence of dementia in institutionalized patients. The RESYDEM study

Introduccióndeterminar la prevalencia de demencia en residencias de ancianos de España y analizar los factores asociados a ella.Material y métodosestudio transversal, observacional y multicéntrico. Residencias pertenecientes a todas las Comunidades Autónomas del Estado español de titularidad pública, privada y concertada. Se incluyó a un total de 852 ancianos institucionalizados, participantes en el estudio RESYDEM.El diagnóstico de demencia se estableció sobre la base de los criterios clínicos del DSM-IV-TR. Como medida del deterioro global o valoración global de la gravedad de la demencia se utilizó la escala Clinical Dementia Rating (CDR) de Hughes. Se recogieron variables sobre características clínicas y sociodemográficas, y los tratamientos farmacológicos de los participantes.Resultadosla prevalencia global de demencia hallada en este estudio fue del 61,7% (intervalo de confianza [IC] del 95%, 58,4–65,1). La enfermedad de Alzheimer se presentó con una prevalencia del 16,9% (IC del 95%, 14,3–19,5). La demencia vascular supone el 7,3% (IC del 95%, 5,5–9,1). El género femenino se asoció de forma independiente con una mayor frecuencia de demencia. Se evidenció una mayor prevalencia de esta afección a medida que aumentaba la edad. Sólo el 18,8% (IC del 95%, 15,4–22,3) de los pacientes con diagnóstico de demencia reciben tratamiento específico para ésta.Conclusionesdos terceras partes de las personas mayores que viven en residencias de ancianos en España presentan demencia. Existe una elevada tasa de infratratamiento de este proceso. Es importante la sensibilización de los profesionales sanitarios para la identificación precoz y para conocer la existencia de tratamientos específicos para la demencia, lo cual debe suponer un cambio radical en el abordaje de la enfermedad (AU)

IntroductionTo determine the prevalence of dementia in nursing homes in Spain and to analyze the associated factors in an elderly population in the institutional setting.Material and methodsWe performed a multicenter, cross-sectional, observational study of 852 residents of public, private and state-assisted nursing homes throughout Spain. Dementia was diagnosed according to the DSM-IV-TR clinical criteria. The Hughes Clinical Dementia Rating scale was used to measure global impairment or the global severity of dementia. Sociodemographic, clinical and neuropsychological variables, together with the pharmacological treatments prescribed to the participants, were recorded.ResultsThe overall prevalence of dementia was 61.7% (95% CI 58.4–65.1) and that of Alzheimer's disease was 16.9% (95% CI 14.3–19.5). Vascular dementia was found in 7.3% (95% CI 5.5–9.1). Female sex was independently associated with a greater frequency of dementia. The prevalence of dementia increased with age. Only 18.8% (95% CI 15.4–22.3) of the patients diagnosed with dementia received specific treatment for the disorder.ConclusionsTwo-thirds of the elderly persons living in nursing homes in Spain have dementia. Undertreatment of this disease is common. Increased awareness among health care professionals is important for the early diagnosis and appropriate management of dementia, which would represent a radical change in the approach to this disease (AU)

[Methods for diagnosing seronegative myasthenia gravis]. / Métodos diagnósticos de la miastenia grave seronegativa.

INTRODUCTION: A peculiar feature of seronegative myasthenia gravis is that it presents negative acetylcholine-receptor antibodies; determination of muscle-specific receptor tyrosine kinase (MuSK) antibodies defines a subgroup of patients with generalised myasthenia gravis with certain clinical and neurophysiological peculiarities. DEVELOPMENT: Its diagnosis requires the presence of weakness with fatigability, determination of positive anti-MuSK antibodies and alterations in neurophysiological testing of the neuromuscular junction. It is usually more serious and has a poorer prognosis than the seropositive forms, develops in an acute or subacute manner, and the neurological deficit predominates in the facial, bulbar and respiratory muscles. CONCLUSIONS: Titration of the anti-MuSK antibodies and conducting neurophysiological tests, especially jitter assessment using single-fibre electromyography in clinically deficient muscles, are not only necessary for an early diagnosis of these clinical forms, but also so as to be able to carry out an objective evaluation of the clinical progression and response to treatment.

Métodos diagnósticos de la miastenia grave seronegativa / Methods for diagnosing seronegative myasthenia gravis

La miastenia grave generalizada seronegativa tiene la peculiaridad de presentar anticuerpos contrael receptor de la acetilcolina negativos; sin embargo, la determinación de anticuerpos contra el receptor de tirosincinasa muscular específica (MuSK) define un subgrupo de pacientes con miastenia grave generalizada con peculiaridades desde un punto de vista clínico y neurofisiológico. Desarrollo. Para su diagnóstico, es necesaria la presencia de debilidad con fatiga,determinación de anticuerpos anti-MuSK positivos y pruebas neurofisiológicas de placa neuromuscular alteradas. Suele ser clínicamente más grave y con peor pronóstico que las formas seropositivas, cursa de forma aguda o subaguda y el déficit neurológicopredomina en la musculatura facial, bulbar y respiratoria. Conclusión. La titulación de los anticuerpos anti-MuSK y la realización de pruebas neurofisiológicas, especialmente la valoración del jitter con electromiografía de fibra simple enmúsculos clínicamente deficitarios, no sólo son necesarias para el diagnóstico precoz de estas formas clínicas, sino también para valorar de forma objetiva la evolución clínica y la respuesta al tratamiento

A peculiar feature of seronegative myasthenia gravis is that it presents negative acetylcholine-receptorantibodies; determination of muscle-specific receptor tyrosine kinase (MuSK) antibodies defines a subgroup of patients with generalised myasthenia gravis with certain clinical and neurophysiological peculiarities. Development. Its diagnosis requires the presence of weakness with fatigability, determination of positive anti-MuSK antibodies and alterations in neurophysiological testing of the neuromuscular junction. It is usually more serious and has a poorer prognosis than the seropositive forms, develops in an acute or subacute manner, and the neurological deficit predominates in the facial, bulbar and respiratory muscles. Conclusions. Titration of the anti-MuSK antibodies and conducting neurophysiological tests, especially jitter assessment using single-fibre electromyography in clinically deficient muscles, are not only necessary for an early diagnosis of these clinical forms, but also so as to be able to carry out an objective evaluation of the clinical progression and response to treatment

[Zonisamide and neuropathic pain]. / Zonisamida y dolor neuropático.

INTRODUCTION: In neuropathic pain, as occurs in epilepsy, researchers are striving to find a drug capable of inhibiting the pain-generating ectopic discharges that are produced as a result of neuronal hyperexcitability. This is mediated by ionic exchanges across the channels of the synaptic membrane. This is why the drugs that act on the different types of channels involved in this transmission can regulate neuronal hyperexcitability and therefore have an effect on the pain. DEVELOPMENT: In recent years researchers have gained a deeper understanding of the mechanisms of action of antiepileptic drugs and, since the discovery of their action on one or several synaptic channels, the use of these agents to treat neuropathic pain has become increasingly common. Patients suffering from central pain are also beginning to benefit from the administration of these drugs, especially agents that have proved to be capable of acting with several mechanisms of action and on several channels at the same time. In addition, fewer and less severe side effects are produced, something that is fundamental if we bear in mind the characteristics of patients with central pain, most of whom are adults and elderly. This, together with the fact that there are fewer interactions with other drugs, has led to the new antiepileptic drugs' becoming the preferred medication for this pathology today. CONCLUSIONS: Zonisamide acts on several types of channels and it is known to have four different mechanisms of action, which means it can be effective in treating these patients, although further studies are required (above all randomised double-blind trials) in order to really evaluate the usefulness of these drugs in the treatment of neuropathic pain.

Zonisamida y dolor neuropático / Zonisamide and neuropathic pain

Como ocurre en la epilepsia, en el dolor neuropático se busca un fármaco capaz de inhibir las descargasectópicas generadoras del dolor que se producen a causa de una hiperexcitabilidad neuronal. Ésta se encuentra mediada por el intercambio iónico a través de los canales de la membrana sináptica. Por esta razón, los fármacos que actúen sobre los diferentes tipos de canales involucrados en dicha transmisión pueden regular la hiperexcitabilidad neuronal y, por tanto,actuar frente al dolor. Desarrollo. En los últimos años, tras tener un mejor conocimiento de los mecanismos de acción de los antiepilépticos y al descubrirse su acción sobre uno o varios canales sinápticos, su uso en dolor neuropático se ha ido extendiendo.El dolor central comienza ahora a beneficiarse del uso de estos fármacos, sobre todo de aquellos que han demostrado ser capaces de actuar con varios mecanismos de acción y sobre varios canales al mismo tiempo. Todo ello unido a la aparición de menos efectos adversos y de menor gravedad, hecho fundamental al tener en cuenta la naturaleza de los pacientes con dolor central, la mayoría adultos y ancianos, junto con el menor número de interacciones con otros fármacos, hace que los nuevos antiepilépticos sean en este momento los fármacos de elección en esta patología. Conclusión. La zonisamidaactúa sobre varios tipos de canales y se le conocen cuatro mecanismos de acción diferentes, por lo que puede ser eficaz en el tratamiento de estos pacientes, aunque se precisan estudios más extensos, sobre todo aleatorizados doble ciego, para evaluarrealmente la utilidad de estos fármacos en el tratamiento del dolor neuropático

In neuropathic pain, as occurs in epilepsy, researchers are striving to find a drug capable of inhibitingthe pain-generating ectopic discharges that are produced as a result of neuronal hyperexcitability. This is mediated by ionic exchanges across the channels of the synaptic membrane. This is why the drugs that act on the different types of channels involved in this transmission can regulate neuronal hyperexcitability and therefore have an effect on the pain. Development.In recent years researchers have gained a deeper understanding of the mechanisms of action of antiepileptic drugs and, since the discovery of their action on one or several synaptic channels, the use of these agents to treat neuropathic pain has becomeincreasingly common. Patients suffering from central pain are also beginning to benefit from the administration of these drugs, especially agents that have proved to be capable of acting with several mechanisms of action and on several channels at thesame time. In addition, fewer and less severe side effects are produced, something that is fundamental if we bear in mind the characteristics of patients with central pain, most of whom are adults and elderly. This, together with the fact that there are fewer interactions with other drugs, has led to the new antiepileptic drugs’ becoming the preferred medication for thispathology today. Conclusions. Zonisamide acts on several types of channels and it is known to have four different mechanisms of action, which means it can be effective in treating these patients, although further studies are required (above all randomised double-blind trials) in order to really evaluate the usefulness of these drugs in the treatment of neuropathic pain

[Cost-minimisation analysis of the pharmacological treatment of epilepsy in Spain]. / Análisis de minimización de costes del tratamiento farmacológico antiepiléptico en España.

AIM: To use a model of economic evaluation to analyse the efficiency of therapy with the antiepileptic drugs indicated in recently diagnosed partial and generalised epilepsy. MATERIALS AND METHODS: The treatment of partial epilepsy and generalised epilepsy in Spain was taken as the basis to design two flexible simulation models of the decision tree type. The time horizon of the study was one year and the perspective was that of the Spanish National Health System, and indirect costs were also included. Clinical effectiveness data were obtained from a review of the literature on clinical trials. Information about resources was obtained from the opinions of a panel of experts. Unitary costs of resources were drawn from Spanish databases (euro 2003). The findings of the study were expressed in terms of average cost per patient with each therapeutic strategy, as well as the incremental cost of the different treatment strategies with respect to valproic acid. RESULTS: According to the literature that was reviewed, there are no differences in effectiveness from one antiepileptic drug to another. The incremental cost of the different therapeutic strategies, with respect to valproic acid, lies between 211 and 911 euros per patient and year in partial epilepsy, and between 1,355 and 1,297 euros per patient and year in the case of generalised epilepsy. CONCLUSIONS: The use of sustained-release valproic acid in recently diagnosed partial and generalised epilepsy would allow savings to be made in resources, with respect to the other antiepileptic drugs, and can therefore be considered to be the most effective therapeutic option.

[Pregabalin. A new treatment for neuropathic pain]. / Pregabalina. Un nuevo tratamiento para el dolor neuropático.

Neuropathic pain is a condition affecting a significant proportion of the world's population. Many therapeutic drugs have been used. They achieve less than satisfactory results and are associated to common side effects that affect the daily life of patients. Pregabalin is a new drug that has been shown to be effective for treating partial epilepsy and peripheral neuropathic pain in clinical trials. It is a structural, but not functional, analogue of GABA. It acts as a ligand of the alpha2-delta subunit, a protein associated to the voltage-dependent calcium channels. Modulation of these channels decreases calcium entry into nerve endings, resulting in a decreased release of several excitatory neurotransmitters. Pregabalin had a linear pharmacokinetics with little variability between the different subjects. It does not bind to plasma proteins, has no liver metabolism, and is excreted trough the kidneys. Few interactions with other drugs may be expected based on these characteristics. In clinical trials, pregabalin has been shown to be effective in postherpetic neuralgia and painful diabetic neuropathy at doses ranging from 150-600 mg/day. The analgesic effects of pregabalin occur in the first few days of treatment and are sustained over time. Side effects are few; most are transient and well-tolerated by patients, and the treatment discontinuation rate is minimal.

Pregabalina. Un nuevo tratamiento para el dolor neuropático / Pregabalin. A new treatment for neuropathic pain

El dolor neuropático afecta a una proporción significativa de la población mundial. Se han usado diferentes agentes terapéuticos, alcanzando resultados poco satisfactorios y asociados a efectos secundarios frecuentes que afectan las actividades de la vida diaria de los pacientes. La pregabalina es un nuevo fármaco que se ha mostrado efectivo en ensayos clínicos en el tratamiento de la epilepsia parcial y el dolor neuropático periférico. Estructuralmente, aunque no funcional mente, es análogo al GABA. Actúa como un ligando de la subunidad alfa2-delta, una proteína asociada a los canales de calcio voltaje dependientes. La modulación de estos canales disminuye la entrada de calcio en las terminales nerviosas, dando como resultado una disminución de la liberación de varios neurotransmisores excitatorios. La pregabalina tiene una farmacocinética lineal con escasa variabilidad interindividual. No se une a las proteínas plasmáticas, no tiene metabolización hepática y se excreta a través del riñón. Estas características hacen que se esperen pocas interacciones con otros fármacos. La pregabalina se ha mostrado eficaz en ensayos clínicos frente a la neuralgia postherpética y la neuropatía diabética dolorosa a dosis que oscilan entre 150-600 mg/día. Los efectos analgésicos ocurren en los primeros días del tratamiento y se mantienen a largo plazo. Los efectos adversos son escasos, la mayoría transitorios y bien tolerados por los pacientes y las tasas de abandonos del tratamiento son mínimas

Neuropathic pain is a condition affecting a significant proportion of the world's population. Many therapeutic drugs have been used. They achieve less than satisfactory results and are associated to common side effects that affect the daily life of patients. Pregabalin is a new drug that has been shown to be effective for treating partial epilepsy and peripheral neuropathic pain in clinical trials. It is a structural, but not functional, analogue of GABA. It acts as a ligand of the alpha2delta subunit, a protein associated to the voltage-dependent calcium channels. Modulation of these channels decreases calcium entry into nerve endings, resulting in a decreased release of several excitatory neurotransmitters. Pregabalin had a linear pharmacokinetics with little variability between the different subjects. It does not bind to plasma proteins, has no liver metabolism, and is excreted trough the kidneys. Few interactions with other drugs may be expected based on these characteristics. In clinical trials, pregabalin has been shown to be effective in postherpetic neuralgia and painful diabetic neuropathy at doses ranging from 150-600 mg/day. The analgesic effects of pregabalin occur in the first few days of treatment and are sustained over time. Side effects are few; most are transient and well-tolerated by patients, and the treatment discontinuation rate is minimal

Análisis de minimización de costes del tratamiento farmacológico antiepiléptico en España / Cost-minimisation analysis of the pharmacological treatment of epilepsy in spain

Objetivo. Analizar mediante un modelo de evaluación económica la eficiencia del tratamiento con los fármacos antiepilépticos indicados en la epilepsia parcial y generalizada de reciente diagnóstico. Materiales y métodos. Se diseñaron dos modelos de simulación flexible del tipo árbol de decisión, basados en el tratamiento de la epilepsia parcial y la epilepsia generalizada en España. El horizonte temporal del estudio fue de un año y la perspectiva fue la del Sistema Nacional de Salud, con inclusión también de los costes indirectos. Los datos de eficacia clínica se obtuvieron de una revisión de la bibliografía de ensayos clínicos. La información sobre uso de recursos se obtuvo de la opinión de un panel de expertos. Los costes unitarios de los recursos se extrajeron de bases de datos españolas (euro 2003). Los resultados del estudio se expresaron como coste medio por paciente con cada estrategia de tratamiento, y como coste incremental de las diferentes estrategias de tratamiento respecto al ácido valproico. Resultados. Según la bibliografía revisada, no existen diferencias en eficacia entre los fármacos antiepilépticos. El coste incremental de las diferentes estrategias de tratamiento respecto al ácido valproico se sitúa entre los 211 y 911 euros por paciente al año en epilepsia parcial, y entre 1.355 y 1.297 euros por paciente al año en epilepsia generalizada. Conclusión. La utilización de ácido valproico de liberación prolongada en la epilepsia parcial y generalizada de reciente diagnóstico supondría un ahorro de recursos respecto a los demás fármacos antiepilépticos; por tanto, puede considerarse la opción terapéutica más eficiente (AU)

Aim. To use a model of economic evaluation to analyse the efficiency of therapy with the antiepileptic drugs indicated in recently diagnosed partial and generalised epilepsy. Materials and methods. The treatment of partial epilepsy and generalised epilepsy in Spain was taken as the basis to design two flexible simulation models of the decision tree type. The time horizon of the study was one year and the perspective was that of the Spanish National Health System, and indirect costs were also included. Clinical effectiveness data were obtained from a review of the literature on clinical trials. Information about resources was obtained from the opinions of a panel of experts. Unitary costs of resources were drawn from Spanish databases (euro 2003). The findings of the study were expressed in terms of average cost per patient with each therapeutic strategy, as well as the incremental cost of the different treatment strategies with respect to valproic acid. Results. According to the literature that was reviewed, there are no differences in effectiveness from one antiepileptic drug to another. The incremental cost of the different therapeutic strategies, with respect to valproic acid, lies between 211 and 911 euros per patient and year in partial epilepsy, and between 1,355 and 1,297 euros per patient and year in the case of generalised epilepsy. Conclusions. The use of sustained-release valproic acid in recently diagnosed partial and generalised epilepsy would allow savings to be made in resources, with respect to the other antiepileptic drugs, and can therefore be considered to be the most effective therapeutic option (AU)

Principio de autonomía en las demencias avanzadas: ¿queremos para los demás lo que no deseamos para nosotros? / The principle of autonomy in advanced dementia: do we want for others what we don't want for ourselves?

En este artículo presentamos nuestro punto de vista sobre algunos aspectos del respeto al principio de autonomía en pacientes con deterioro cognitivo severo. El trabajo se estructura sobre los debates planteados en 2 jornadas sobre demencias a las que asistieron profesionales implicados en la asistencia a estos pacientes, así como familiares y cuidadores no profesionales de éstos. A los asistentes se les entregó un cuestionario con 3 preguntas sobre cuáles serían sus preferencias respecto a tratamientos médicos en caso de sufrir una incapacidad mental y física severa e irreversible. Los resultados de dicho cuestionario sólo son utilizados, como lo fueron en las jornadas mencionadas, como una forma de introducirnos en el debate y plantear la discusión sobre aspectos aún no del todo aclarados en este ámbito. (AU)

[Encephalitis caused by Rickettsia conorii without exanthema]. / Encefalitis por Rickettsia conorii sin exantema.

INTRODUCTION: Mediterranean boutonneuse fever, caused by Rickettsia conorii, is an endemic disease in the Mediterranean area. The serious forms of the disease, which include encephalitis, are infrequent but are associated with a high mortality rate. Diagnostic suspicion is backed up by the development of exanthema. We report the case of a patient who developed encephalitis caused by Rickettsia conorii without exanthema. Clinical case. A 27 year old woman who had nauseas, headache, fever, abdominal upset and generalised pain during the days before being admitted to hospital. On the day she was admitted, she noticed reduced strength in the left limbs, together with numbness and pins and needles in the left side of the body. In the casualty department she presented tonic seizures in the left extremities and later generalised tonic clonic seizures. Exploration showed facial paresis and 4/5 hemiparesis on the left side. Complementary tests carried out in casualty, including cerebrospinal fluid (CSF), did not reveal any significant findings. She was admitted after a loading dose of phenytoin. After 48 hours she presented fever and repeated complex partial seizures. A new CSF analysis was normal. She was treated with valproate, clonazepam, ceftriaxone, doxycycline and acyclovir. An electroencephalogram (EEG) showed theta activity in the left centroparietal areas and slow delta waves in the right temporal regions. Magnetic resonance imaging (MRI) of the brain showed contrast enhancement in the meninges. 24 later, due to the frequency of the seizures, phenobarbital and methylprednisolone were added, which enabled the seizures to be controlled. The posterior brain MRI revealed a right parasylvian lesion. Serological Rickettsia conorii IgM +, IgG 1/256 was administered. After eight months, she has presented no seizures or neurological deficit. CONCLUSIONS: There are cases of encephalitis from Rickettsia conorii that can present without exanthema. This means that in endemic areas early treatment with doxycycline could be advisable when faced with encephalitis of unknown aetiology, bearing in mind the high mortality rate that occurs when no early treatment is administered and the good tolerance to doxycycline.