Consenso de expertos españoles sobre el uso de la safinamida en la enfermedad de Parkinson / Spanish expert consensus on the use of safinamide in Parkinson's disease

La safinamida es un nuevo fármaco para el tratamiento de pacientes con enfermedad de Parkinson (EP) con fluctuaciones como tratamiento complementario a levodopa. Dado que por el momento aún no existen estudios de fase IV postautorización debido a la reciente incorporación de la safinamida a la práctica clínica habitual, el interés de este proyecto radica en el desarrollo de una guía de manejo clínico de la safinamida basada en las opiniones de expertos de trastornos del movimiento. Este proyecto se desarrolló en 2 fases: una primera fase que constó de 16 reuniones locales y una segunda fase que consistió en una reunión nacional. Dichas reuniones siguieron un guion de trabajo preestablecido. Tras la reunión nacional se recopilaron las principales conclusiones de los expertos, que han supuesto la base para redactar la presente guía clínica. Se concluyó que la safinamida es eficaz en la reducción de las fluctuaciones motoras y no motoras. Los pacientes con EP con fluctuaciones leves-moderadas son los que más se benefician del tratamiento, si bien el fármaco puede contribuir a mejorar diversos problemas clínicos en pacientes con EP avanzada. Se ha destacado la posibilidad de reducir la dosis de otros fármacos dopaminérgicos tras la introducción de la safinamida, lo cual contribuiría a reducir efectos adversos como el trastorno de control de impulsos. Se hipotetizó sobre el posible efecto de la safinamida sobre la mejoría de las discinesias a dosis más altas de las habitualmente utilizadas. Se ha consensuado que la safinamida es bien tolerada y presenta un perfil de efectos adversos favorable frente a placebo. (AU)

Safinamide is a new add-on drug to levodopa for the treatment of Parkinson's disease (PD) with motor fluctuations. Due to the recent incorporation of safinamide into routine clinical practice, no post-authorisation phase IV studies on the safety of safinamide have been conducted to date. This study provides clinical management guidelines for safinamide based on the opinion of a group of experts in movement disorders. This project was developed in 2 phases: 16 local meetings in phase 1 and a national meeting in phase 2. The meetings followed a pre-established agenda. The present clinical practice guidelines are based on the main conclusions reached during the national meeting. The group concluded that safinamide is effective in reducing motor and non-motor fluctuations. PD patients with mild-to-moderate fluctuations benefit most from treatment, although the drug may also improve the clinical status of patients with advanced PD. The dose of other dopaminergic drugs may be reduced after introducing safinamide, which would contribute to reducing such adverse reactions as impulse control disorder. At doses higher than those usually prescribed, safinamide may also improve dyskinesia. The experts agreed that safinamide is well tolerated and causes few adverse reactions when compared with placebo. (AU)

Spanish expert consensus on the use of safinamide in Parkinson's disease.

Safinamide is a new add-on drug to levodopa for the treatment of Parkinson's disease (PD) with motor fluctuations. Due to the recent incorporation of safinamide into routine clinical practice, no post-authorisation phase IV studies on the safety of safinamide have been conducted to date. This study provides clinical management guidelines for safinamide based on the opinion of a group of experts in movement disorders. This project was developed in 2 phases: 16 local meetings in phase 1 and a national meeting in phase 2. The meetings followed a pre-established agenda. The present clinical practice guidelines are based on the main conclusions reached during the national meeting. The group concluded that safinamide is effective in reducing motor and non-motor fluctuations. PD patients with mild-to-moderate fluctuations benefit most from treatment, although the drug may also improve the clinical status of patients with advanced PD. The dose of other dopaminergic drugs may be reduced after introducing safinamide, which would contribute to reducing such adverse reactions as impulse control disorder. At doses higher than those usually prescribed, safinamide may also improve dyskinesia. The experts agreed that safinamide is well tolerated and causes few adverse reactions when compared with placebo.

Spanish expert consensus on the use of safinamide in Parkinson's disease. / Consenso de expertos españoles sobre el uso de la safinamida en la enfermedad de Parkinson.

Safinamide is a new add-on drug to levodopa for the treatment of Parkinson's disease (PD) with motor fluctuations. Due to the recent incorporation of safinamide into routine clinical practice, no post-authorisation phase IV studies on the safety of safinamide have been conducted to date. This study provides clinical management guidelines for safinamide based on the opinion of a group of experts in movement disorders. This project was developed in 2 phases: 16 local meetings in phase 1 and a national meeting in phase 2. The meetings followed a pre-established agenda. The present clinical practice guidelines are based on the main conclusions reached during the national meeting. The group concluded that safinamide is effective in reducing motor and non-motor fluctuations. PD patients with mild-to-moderate fluctuations benefit most from treatment, although the drug may also improve the clinical status of patients with advanced PD. The dose of other dopaminergic drugs may be reduced after introducing safinamide, which would contribute to reducing such adverse reactions as impulse control disorder. At doses higher than those usually prescribed, safinamide may also improve dyskinesia. The experts agreed that safinamide is well tolerated and causes few adverse reactions when compared with placebo.

[Early-onset Parkinsonism. A report on a Spanish series]. / Parkinson de inicio precoz. A proposito de una serie espanola.

INTRODUCTION: Early-onset Parkinsonism is a condition that has received little attention from researchers due to its low incidence and prevalence. We conducted a retrospective, cross-sectional, multi-centre study in order to obtain a representative sample of the Spanish population. PATIENTS AND METHODS: The study involved 92 Spanish patients who had been diagnosed with idiopathic Parkinson's disease that began before the age of 40 years and these patients were divided into two groups: group 1, which consisted of 86 patients, with an age at onset of between 21 and 40 years (early-onset Parkinsonism), and group 2, with an age at onset of below 21 years, which included a total of 6 patients (juvenile Parkinsonism). Our analysis involved demographic data, patient's personal and family history, age and symptoms of onset of the disease, complementary studies, drug therapy and pharmacological complications. RESULTS: In group 1 we found a high incidence of early-onset Parkinsonism in the family. In our series there was a clear predominance of patients from urban settings. The predominant form of onset was akinesia, followed by tremor at rest, rigidity and postural tremor. Since they began treatment with levodopa, some patients presented fluctuations and dyskinesias which progressively increased over the years. CONCLUSIONS: Our series of patients is not wholly similar to those reported in the literature; it is comparable, however, to those found in western countries and can be considered to be valid due to the number of cases analysed and owing to the fact that patients were selected from different areas around Spain. This provides an overall picture of this subtype of Parkinson's disease for the country as a whole.

Parkinson de inicio precoz. A propósito de una serie española / Early-onset parkinsonism a report on a Spanish series

El Parkinson de inicio precoz es una entidad poco estudiada a causa de la baja incidencia y prevalencia.Hemos realizado un estudio retrospectivo transversal multicéntrico para tener una muestra representativa de la población española. Pacientes y métodos. Se incluyeron en el estudio 92 pacientes españoles diagnosticados de enfermedad de Parkinsonidiopática de inicio antes de los 40 años, que se dividieron en dos grupos: grupo 1, con 86 pacientes, con edad de inicio entre 21 y 40 años (Parkinson de inicio precoz), y grupo 2, con edad de inicio inferior a los 21 años, con un total de 6 pacientes (Parkinson juvenil). Analizamos: datos demográficos, antecedentes personales y familiares, edad y síntomas de comienzode la enfermedad, estudios complementarios, farmacoterapia y complicaciones farmacológicas. Resultados. En el grupo 1 encontramos una gran incidencia familiar de Parkinson de inicio precoz. En nuestra serie hubo un claro predominiode pacientes del medio urbano. La forma predominante de inicio fue la acinesia, seguida del temblor de reposo, rigidez y temblor de actitud. Algunos pacientes presentaron, desde el inicio del tratamiento con levodopa, fluctuaciones y discinesias queaumentaron progresivamente a lo largo de los años. Conclusiones. Nuestra serie de pacientes no es totalmente similar con lasdescritas en la literatura; sí es parecida a las encontradas en los países occidentales y tiene validez por el número de casosanalizados y por seleccionar pacientes de varios sitios del territorio español, dando una imagen general sobre este subtipo de enfermedad de Parkinson nacionalmente

Early-onset Parkinsonism is a condition that has received little attention from researchers due to itslow incidence and prevalence. We conducted a retrospective, cross-sectional, multi-centre study in order to obtain a representative sample of the Spanish population. Patients and methods. The study involved 92 Spanish patients who had been diagnosed with idiopathic Parkinson's disease that began before the age of 40 years and these patients were divided into twogroups: group 1, which consisted of 86 patients, with an age at onset of between 21 and 40 years (early-onset Parkinsonism), and group 2, with an age at onset of below 21 years, which included a total of 6 patients (juvenile Parkinsonism). Our analysisinvolved demographic data, patient’s personal and family history, age and symptoms of onset of the disease, complementary studies, drug therapy and pharmacological complications. Results. In group 1 we found a high incidence of early-onset Parkinsonism in the family. In our series there was a clear predominance of patients from urban settings. The predominant form of onset was akinesia, followed by tremor at rest, rigidity and postural tremor. Since they began treatment with levodopa, some patients presented fluctuations and dyskinesias which progressively increased over the years. Conclusions. Our series of patients is not wholly similar to those reported in the literature; it is comparable, however, to those found in western countries and can be considered to be valid due to the number of cases analysed and owing to the fact that patients were selected from different areas around Spain. This provides an overall picture of this subtype of Parkinson's disease for the country as a whole