Evaluación de la conveniencia del cambio de vía de administración de rivastigmina en pacientes con enfermedad de Alzheimer / Evaluation of the convenience of changing the rivastigmine administration route in patients with Alzheimer disease

Introducción: Los parches transdérmicos de rivastigmina para el tratamiento de la enfermedad de Alzheimer presentan posibles beneficios respecto a las cápsulas por su absorción sostenida a través de la piel, buena tolerabilidad local y reducción de problemas gastrointestinales. Objetivo: Evaluar la tolerabilidad gastrointestinal y cutánea y la necesidad de titulación para obtener dosis óptimas de rivastigmina transdérmica en pacientes con Alzheimer previamente tratados oralmente. Pacientes y métodos: Se llevó a cabo un estudio multicéntrico, aleatorizado y abierto que incluyó a 142 pacientes con Alzheimer de leve a moderado y previamente tratados con rivastigmina oral (6-12 mg/día). La muestra fue aleatorizada a: continuar con tratamiento oral durante 3 meses (n = 49); cambio al parche sin titulación (9,5 mg/día durante 3 meses, n = 47) o cambio al parche con titulación (4,6 mg/día por 1 mes seguido de 9,5 mg/día por 2 meses, n = 43). Resultados: La incidencia de efectos adversos gastrointestinales fue del 6,1% en el grupo tratado oralmente y del 4,2% en el grupo tratado con parche sin titulación (p = 0,908). La tolerabilidad cutánea fue buena (n = 15, 16,7%), sin observarse acontecimientos adversos graves. El tratamiento con parche fue considerado muy fácil de utilizar por el 72% de pacientes en comparación con el 30% con tratamiento oral (p = 0,0005). El 60% se mostraron satisfechos con el parche, mientras que únicamente un 14% se declaró satisfecho con las cápsulas (p < 0,0001). Conclusiones: Los parches de rivastigmina presentan un perfil de tolerabilidad similar a las cápsulas y se asocian con una mayor satisfacción de los pacientes (AU)

Introduction: Rivastigmine transdermal patches for the treatment of Alzheimer’s disease (AD) have potential benefits compared to capsules because of their sustained absorption through the skin, good local tolerability and reduction of gastrointestinal problems. Purpose: To assess gastrointestinal and skin tolerability and the need for optimal dose titration of rivastigmine transdermal patches in Alzheimer’s disease patients previously treated with oral rivastigmine. Patients and methods: A multicenter, randomized, open-label study including patients with mild to moderate AD (DSM-IV) previously treated with rivastigmine capsules (6-12 mg/day) was conducted. Patients were randomized to: continue with capsules for 3 months (n = 49) or switch to rivastigmine patch without titration (9.5 mg/day for 3 months; n = 48), or switch to rivastigmine patch with titration (4.6 mg/day for 1 month followed by 9.5 mg/day for 2 months, n = 43). Results: Incidence of gastrointestinal adverse events was 6.1% in the group treated orally and 4.2% in the group treated with non-titrated patches (P = .908). Skin tolerability was good (n = 15, 16.7%) without any serious adverse events registered. Patch treatment was considered very easy to use by 72% of patients compared with 30% in the group with oral treatment (P = .0005). 60% of patients were satisfied with the patch, while only 14% were satisfied with capsules (P < .0001). Conclusions: Rivastigmine patches have a tolerability profile similar to that shown by capsules, but are associated with greater patient satisfaction (AU)

Evaluation of the convenience of changing the rivastigmine administration route in patients with Alzheimer disease.

INTRODUCTION: Rivastigmine transdermal patches for the treatment of Alzheimer's disease (AD) have potential benefits compared to capsules because of their sustained absorption through the skin, good local tolerability and reduction of gastrointestinal problems. PURPOSE: To assess gastrointestinal and skin tolerability and the need for optimal dose titration of rivastigmine transdermal patches in Alzheimer's disease patients previously treated with oral rivastigmine. PATIENTS AND METHODS: A multicenter, randomized, open-label study including patients with mild to moderate AD (DSM-IV) previously treated with rivastigmine capsules (6-12 mg/day) was conducted. Patients were randomized to: continue with capsules for 3 months (n=49) or switch to rivastigmine patch without titration (9.5mg/day for 3 months; n=48), or switch to rivastigmine patch with titration (4.6 mg/day for 1 month followed by 9.5mg/day for 2 months, n=43). RESULTS: Incidence of gastrointestinal adverse events was 6.1% in the group treated orally and 4.2% in the group treated with non-titrated patches (P=.908). Skin tolerability was good (n=15, 16.7%) without any serious adverse events registered. Patch treatment was considered very easy to use by 72% of patients compared with 30% in the group with oral treatment (P=.0005). 60% of patients were satisfied with the patch, while only 14% were satisfied with capsules (P<.0001). CONCLUSIONS: Rivastigmine patches have a tolerability profile similar to that shown by capsules, but are associated with greater patient satisfaction.

Propuesta para un registro clínico de demencias / A proposal for a clinical registry of dementias

Objetivo. Se presenta una propuesta de las característicasestructurales y funcionales necesarias para desarrollar un registrode demencias que permita recoger con garantías de fiabilidady validez la información estandarizada de los casos diagnosticadosde demencia en los centros sanitarios de atención especializada deun área geográfica definida. Desarrollo. Debido a la falta de informaciónsobre los aspectos relativos al impacto de las demenciassobre el sistema sanitario, en términos de utilización de recursos yen patrones de detección, derivación, diagnóstico y tratamiento enla práctica clínica habitual por parte de atención primaria y secundaria,se propone una implementación secuencial del registro paraadaptarse a cada territorio o región sanitaria. En primer lugar, sedeberían identificar los casos y las fuentes de información; en segundolugar, desarrollar un sistema de recogida de datos que permitaadoptar de forma estandarizada la recogida de información yestablecer una estrecha colaboración con los especialistas que llevena cabo el diagnóstico de demencia; y, en tercer lugar, aportar alregistro una estructura logística y de personal que centralice todaslas funciones y actividades del registro. Conclusiones. La vigilanciaepidemiológica es un instrumento fundamental para la planificación,gestión y distribución de los recursos sociosanitarios, para elseguimiento de la evolución natural de enfermedades crónicas asícomo para evaluar el impacto de programas preventivos. En estesentido, y desde un punto de vista funcional, la propuesta de unregistro de demencias cumple todos los requisitos básicos de la vigilanciaepidemiológica

Aims. We outline a proposal for the structural and functional features needed to develop a registry of dementiaswhich can be used to collect standardised information that is both reliable and valid concerning cases of dementia in thespecialised health care centres within a particular geographical area. Development. Due to the shortage of information aboutaspects concerning the impact of dementias on the health care system (in terms of the usage of resources and patterns ofdetection, referral, diagnosis and treatment in usual clinical practice in primary and secondary care), a sequentialimplementation of the registry is proposed so that it can be adapted to each health district or region. The first step is to identifythe cases and sources of information; second, a system for collecting data must be developed that allows information to begathered in a standardised manner while at the same time making it possible to work in close collaboration with thespecialists who diagnose dementia; and, third, it must be set up with the logistics and staff needed to centralise all thefunctions and activities of the registry. Conclusions. Epidemiological surveillance is an essential instrument for planning,managing and distributing community health resources, for following up the natural history of chronic diseases and forassessing the impact of programmes of prevention. In this respect, and from a functional point of view, the proposed registry ofdementias meets all the basic requirements of epidemiological surveillance

[A proposal for a clinical registry of dementias]. / Propuesta para un registro clinico de demencias.

AIMS: We outline a proposal for the structural and functional features needed to develop a registry of dementias which can be used to collect standardised information that is both reliable and valid concerning cases of dementia in the specialised health care centres within a particular geographical area. DEVELOPMENT: Due to the shortage of information about aspects concerning the impact of dementias on the health care system (in terms of the usage of resources and patterns of detection, referral, diagnosis and treatment in usual clinical practice in primary and secondary care), a sequential implementation of the registry is proposed so that it can be adapted to each health district or region. The first step is to identify the cases and sources of information; second, a system for collecting data must be developed that allows information to be gathered in a standardised manner while at the same time making it possible to work in close collaboration with the specialists who diagnose dementia; and, third, it must be set up with the logistics and staff needed to centralise all the functions and activities of the registry. CONCLUSIONS: Epidemiological surveillance is an essential instrument for planning, managing and distributing community health resources, for following up the natural history of chronic diseases and for assessing the impact of programmes of prevention. In this respect, and from a functional point of view, the proposed registry of dementias meets all the basic requirements of epidemiological surveillance.

Estudio clinico terapéutico de la demencia en las personas con síndrome de down y eficacia del donepecilo en esta población / Clinical-therapeutic study of dementia in people with down syndrome and the effectiveness of donepezil in this population

Introducción. Las personas con síndrome de Down envejecen precozmente, sobre todo a partir de los 40 años, mientras un porcentaje significativo inicia, a partir de esta edad, un deterioro progresivo de sus capacidades cognitivas y funcionales previas, secundario todo ello a un proceso degenerativo primario de tipo enfermedad de Alzheimer. Estudios clínicos piloto en esta población, en los que se ha valorado la repuesta al tratamiento con donepecilo, han demostrado beneficios terapéuticos. Objetivo. Evaluar la eficacia y seguridad del tratamiento farmacológico con donepecilo sobre los trastornos cognitivos y conductuales en población con síndrome de Down mayor de 40 años, en la que la familia y educadores de referencia han observado cambios cognitivos y conductuales respecto a su nivel previo de discapacidad. Pacientes y métodos. Los pacientes han sido seleccionados a través de diferentes instituciones filiadas por la Fundació Catalana de Síndrome de Down y por la Federación Catalana Pro Personas con Disminución Psíquica. Se han utilizado escalas de valoración de deterioro, conducta y funcionalismo adaptadas a esta población. Resultados. Los resultados del estudio han demostrado que el donepecilo ralentiza la progresión de la disfunción cognitiva, especialmente durante los primeros tres meses de tratamiento. Esto sucede tanto en las escalas cognitivas como sociales. Conclusiones. El donepecilo parece ser efectivo en el tratamiento de los trastornos cognitivos y de la conducta en la demencia progresiva del síndrome de Down. Todas las muestras publicadas en diferentes estudios han sido pequeñas, lo que hace necesario poner en marcha estudios multicéntricos para validar la respuesta de estos sujetos a la terapia anticolinesterásica (AU)

Introduction. People with Down syndrome have an early aging process, especially form their 40s. There is a significant average of them who initiate, from that age on, a progressive decline of their cognitive and functional abilities, due to a primary degenerative process Alzheimer’s disease type. When assessing response to treatment with, pilot clinical trials on this population have demonstrated real benefits therapeutically. Aims. To assess the efficacy and safety of a pharmacological treatment with donepezil over cognitive and behavioral disturbances on patients with Down syndrome older than 40 years, areas where family and professional educators of reference have observed cognitive and behavioral changes in comparison with their previous level of disability. Patients and methods. Patients have been selected from different institutions affiliated at the Catalan Foundation for the Down syndrome and by the Catalan Federation Pro Persons with Psychic Disability. Several deterioration, behavioral and functional assessment scales have been used, all of them validated into this population. Results. The results of study demonstrated that donepezil slowed the progression of the cognitive dysfunction, especially during the first three months of treatment. This occurred for both cognitive and social-behavioral outcomes. Conclusions. Donepezil appears to be effective in the treatment of cognitive and behavioural disturbances associated with the progressive dementia syndrome in Down’s. However, the sample sizes used in this, and all published studies are small and this emphasizes the need for a larger, multi-center trial to fully evaluate the nature and extent of the response of Down's syndrome patients to anticolinesterase therapy (AU)

[Clinical-therapeutic study of dementia in people with Down syndrome and the effectiveness of donepezil in this population]. / Estudio clinicoterapéutico de la demencia en las personas con síndrome de Down y eficacia del donepecilo en esta población.

INTRODUCTION: People with Down syndrome have an early aging process, especially form their 40s. There is a significant average of them who initiate, from that age on, a progressive decline of their cognitive and functional abilities, due to a primary degenerative process Alzheimer's disease type. When assessing response to treatment with, pilot clinical trials on this population have demonstrated real benefits therapeutically. AIMS: To assess the efficacy and safety of a pharmacological treatment with donepezil over cognitive and behavioral disturbances on patients with Down syndrome older than 40 years, areas where family and professional educators of reference have observed cognitive and behavioral changes in comparison with their previous level of disability. PATIENTS AND METHODS: Patients have been selected from different institutions affiliated at the Catalan Foundation for the Down syndrome and by the Catalan Federation Pro Persons with Psychic Disability. Several deterioration, behavioral and functional assessment scales have been used, all of them validated into this population. RESULTS: The results of study demonstrated that donepezil slowed the progression of the cognitive dysfunction, especially during the first three months of treatment. This occurred for both cognitive and social-behavioral outcomes. CONCLUSIONS: Donepezil appears to be effective in the treatment of cognitive and behavioural disturbances associated with the progressive dementia syndrome in Down's. However, the sample sizes used in this, and all published studies are small and this emphasizes the need for a larger, multi-center trial to fully evaluate the nature and extent of the response of Down's syndrome patients to anticolinesterase therapy.

[Eye conditions as features of Down's syndrome in patients over 40 years of age]. / Trastornos oculares propios del síndrome de Down en mayores de 40 años.

AIMS: The purpose of this study was to determine the refractive status and ocular health of a group of patients with Down's syndrome, all over the age of 40, with possible involvement of Alzheimer's disease (AD). We also aimed to compare the results obtained from sufferers and non-sufferers of the disease. PATIENTS AND METHODS: We examined 49 patients, between 40 and 62 years of age. The visual examination consisted in visual acuity (VA) measurement, binocularity test, ocular motility, retinoscopy, ocular health and subjective examination. RESULTS: Of the 49 patients studied, 24.5% were diagnosed as suffering from AD and were treated accordingly; 4% of the patients diagnosed as suffering from the disease were unable to go on with the treatment for a number of different reasons and 8.2% were at the limit of being diagnosed. 68.7% of the patients presented VA in long distance sight below 0.5 and 48% had values below 0.4 in near sight. Results showed 61.4% myopias, 45.8% astigmatisms and 23% hyperopias. 31.2% of the patients showed signs of needing prescription regarding near sight. 66.7% presented strabismus and altered motility. The main pathologies found were: 59.4% of crystalline opacities, 25% nystagmus, 13.5% interventions due to cataracts, and 6.2% keratoconus, among others. CONCLUSIONS: Diagnosis of AD is a very complex task in this population due to the heterogeneity of the level of retardation, the presence of concomitant psychiatric diseases and associated sensory problems. Findings confirm the high incidence among this population of ametropias and pathologies, especially cataracts, and VA values outside the functional limits both in far and near sightedness. No significant differences were found among patients who had been diagnosed and those who had not been diagnosed as suffering from AD.

[Advanced directives document and neurologist-patient relationship]. / El documento de voluntades anticipadas y la relación neurólogo-paciente.

Perception of health and disease, pain and suffering, quality of life, personal relationships, privacy and intimacy, culture and social values, can now be stated in a written document, by way of a living will, giving legal legitimacy to each patient's way of being and understanding life, to be used when the subject cannot express it by him/herself. In this way, the patients will participate in the therapeutic process and will incorporate their desires and decisions through the Informed Consent and the Advanced Directives Document (ADD). Both documents translate and indicate how to treat and care for a patient who will progressively lose his/her cognitive faculties and others will decided for him/her, in the case of dementias. The basis of ADD is respect and promotion of the patient's autonomy, prolonging his/her right to decide in the stages in which he/she cannot do it. It consists in some instructions or orientations for the patient to be cared for in a certain way, according to his/her will. To this effect, a representative will be named who will act in the subject's name and who will help to interpret and make decisions when the patient cannot. Specifically, in Alzheimer's disease, ADD allows the patient to decide, in full lucidity, freedom and autonomy, how to live a progressive and irreversible disease. Explicit mention can be made to the will of making his/her disease known publically or not, the care of its aspect, privacy, type of care, whether institutionalized or home care, limitation of visits, treatment intensity and prolongation, palliative cares, donation of biological samples, participation in drug clinical trials.

[Strategies for the treatment of Alzheimer's disease. The 'ad continuum' concept]. / Estrategias terapéuticas en la enfermedad de Alzheimer: Concepto "ad continuum"

The patient with dementia suffers a chronic disorder, with no specific treatment and little therapeutic response, which is accompanied by high co morbidity and additional complications which cause multiple symptoms which limit the patient s autonomy still further, modify the environment and create progressive dependence. Thus, from all angles, approach is very difficult both in seeking the cause and in prevention and also for treatment. The objective of this review is to establish the guidelines for treatment in view of the long term course of the disorder, in accordance with the specific weight and intensity of symptoms from the onset of the illness by means of precise diagnosis of the deficits and control of the commonest disorders which occur over time, such as psycho affective, psychotic, sleep disorders or treatment of a state of confusion and control of the diseases which are most frequent in this population. Finally, we briefly analyze the health care and social requirements of these patients and suggest general recommendations for carers to improve management, classifying the states of dementia into three degrees of severity.

Estrategias terapéuticas en la enfermedad de Alzheimer:concepto ad continuum / Strategies for the treatment of Alzheimer´s disease: the ´ad continuum concept

Introducción. El enfermo con demencia sufre un proceso crónico-evolutivo, sin tratamiento específico y con escasa respuesta terapéutica, que se acompaña de una alta comorbilidad, complicaciones añadidas que dan lugar a la presencia de múltiples síntomas que limitan aún más su autonomía, modifican el entorno y crean una progresiva dependencia. Por ello, desde cualquier punto de vista, su abordaje presenta grandes dificultades, tanto en la búsqueda de su causalidad y prevención, como en su estrategia terapéutica. Desarrollo. El objetivo de esta revisión es establecer unas pautas de tratamiento que contemplen el continuo evolutivo de la enfermedad, acordes al peso específico e intensidad de los síntomas, desde el inicio de la clínica, a partir de un riguroso diagnóstico de los déficit, hasta el control sintomático de los trastornos más frecuentes que irán apareciendo a lo largo del tiempo como los trastornos psicoafectivos, psicóticos, del sueño o el tratamiento del estado confusional, así como del control de las enfermedades más comunes en esta población. Para terminar se analizan, de forma breve, las necesidades asistenciales y sociales destinadas a la atención de estos enfermos, y se proponen recomendaciones globales destinadas a los cuidadores para su mejor manejo, esquematizando los estadios de la demencia en tres gradientes de gravedad (AU)