[The effectiveness and tolerance of piribedil as adjunct therapy to levodopa in patients with Parkinson's disease: a nine month follow up]. / Eficacia y tolerancia del piribedil como terapia adjunta a la levodopa en pacientes con enfermedad de Parkinson: seguimiento de nueve meses.

INTRODUCTION: Piribedil is a D2 D3 dopamine agonist, which has been shown to be well tolerated and to improve Parkinsonian symptoms, particularly tremor. However, few studies have been published about this Dopamine Agonist as an adjunct to levodopa therapy in patients with Parkinson's disease (PD). This placebo controlled, parallel group study was undertaken to investigate the effects of piribedil in PD patients insufficiently controlled with levodopa in a nine months follow up. PATIENTS AND METHODS: We included 62 PD patients insufficiently controlled with levodopa and needed an increase in dopamine stimulation. Patients were randomized in two similar groups, one of them taking Piribedil and levodopa and the other group taking a placebo and levodopa. The primary efficacy measures were the items II and III of the UPDRS. The patients were evaluated prior to the start of therapy, and 3, 6 and 9 months after the start of the study. RESULTS: Patients taking Piribedil showed an average of improvement of 37,8% (p < 0.01) in the part II and 63,2% (p < 0.01) in the part III of the UPDRS at the end of the study. At 9 month evaluation, tremor at rest showed an average improvement of 68,6%, rigidity, fingers taps and legs agility improved substantially in their respective items of the UPDRS at the end of the study. CONCLUSIONS: We concluded that PD patients with functional worsening while on stable levodopa doses exhibit a steady improvement of the UPDRS part II and III with the adjunction of Piribedil 150 mg mean daily dose for 9 months.

Eficacia y tolerancia del piribedil como terapia adjunta a la levodopa en pacientes con enfermedad de Parkinson: seguimiento de nueve meses / The effectiveness and tolerance of piribedil as adjunct therapy to levodopa in patients with Parkinson's disease: a nine-month follow-up

Introducción. El piribedil es un agonista dopaminérgico (AD) D2-D3, eficaz en el control de síntomas parkinsonianos, particularmente el temblor. Sin embargo, hay pocos estudios publicados con seguimientos mayores de tres meses sobre este AD como terapia adjunta a la levodopa en pacientes con la enfermedad de Parkinson (EP). Este estudio se diseñó para investigar los efectos del piribedil en pacientes con EP, tratados con levodopa y con deterioro funcional (DF) en un seguimiento de nueve meses. Pacientes y métodos. Incluimos 62 pacientes con EP sin complicaciones atribuibles a la levodopa y con DF y motor. Los pacientes se distribuyeron de una manera aleatoria en dos grupos similares, levodopa más piribedil o levodopa más placebo. La eficacia se valoró con las partes II y III de la escala unificada para la valoración de la EP (UPDRS) y la tolerancia se valoró con un cuestionario para detectar efectos adversos. Se hizo una valoración basal y a los 3, 6 y 9 meses posteriores al inicio de la terapia. Resultados. Los pacientes que tomaron piribedil mostraron un porcentaje diferencial de mejoría de 37,8 por ciento (p < 0,01) en la parte II del UPDRS y 63,2 por ciento (p < 0,01) en la parte III del UPDRS. Mostraron una mejoría del 68,6 por ciento en el ítem `temblor de reposo' al final del protocolo; también hubo una mejoría notable en el resto de los síntomas cardinales parkinsonianos. Conclusión. Los pacientes de este estudio, con EP y DF, mostraron una mejoría progresiva y sostenible en las partes II y III de la UPDRS durante nueve meses al agregarse 150 mg/día de piribedil, como terapia adjunta a la levodopa. Los efectos adversos fueron similares a los comunicados por otros AD (AU)

Introduction. Piribedil is a D2-D3 dopamine agonist, which has been shown to be well tolerated and to improve Parkinsonian symptoms, particularly tremor. However, few studies have been published about this dopamine agonist as an adjunct to levodopa therapy in patients with Parkinson’s disease (PD). This placebo controlled, parallel group study was undertaken to investigate the effects of piribedil in PD patients insufficiently controlled with levodopa in a nine months follow up. Patients and methods. We included 62 PD patients insufficiently controlled with levodopa and needed an increase in dopamine stimulation. Patients were randomized in two similar groups, one of them taking piribedil and levodopa and the other group taking a placebo and levodopa. The primary efficacy measures were the items II and III of the UPDRS. The patients were evaluated prior to the start of therapy, and 3, 6 and 9 months after the start of the study. Results. Patients taking piribedil showed an average of improvement of 37,8% (p < 0.01) in the part II and 63,2% (p < 0.01) in the part III of the UPDRS at the end of the study. At 9-month evaluation, tremor at rest showed an average improvement of 68,6%, rigidity, fingers taps and legs agility improved substantially in their respective items of the UPDRS at the end of the study. Conclusions. We concluded that PD patients with functional worsening while on stable levodopa doses exhibit a steady improvement of the UPDRS part II and III with the adjunction of piribedil 150 mg mean daily dose for 9 months (AU)