Long‐term efficacy and safety of pramipexole in advanced Parkinson's disease: Results from a European multicenter trial

Abstract

A double-blind, placebo-controlled study with a subsequent open-label phase was conducted in 354 patients with Parkinson's disease (PD) and motor fluctuations under individually adjusted therapy with levodopa. During the double-blind phase 174 patients received pramipexole and 180 placebo. In agreement with previous studies, pramipexole treatment improved UPDRS sum scores of parts II and III by 30% and off times by approximately 2.5 hours per day. Differences between the treatment groups became significant at a daily dose of 0.75 mg of pramipexole dihydrochloride. We, furthermore, performed post hoc analyses with respect to resting tremor and depression. Patients with pronounced resting tremor derived a clear benefit from pramipexole treatment compared with placebo. In addition, pramipexole significantly improved the subitems motivation/initiative and depression in a subpopulation with increased Unified Parkinson's Disease Rating Scale I scores at the time of inclusion. There were 262 patients who were subsequently enrolled into the open-label study featuring a maximum duration of up to 57 months. Statistical analysis revealed good long-term efficacy and tolerability of pramipexole. Overall, only a low prevalence of somnolence was found. In summary, this study provides additional level I evidence of the usefulness of pramipexole, suggests a particular tremorlytic and a possible antidepressant action of this compound, and addresses for the first time its efficacy and safety during long-term administration in advanced PD.

Pramipexole in Parkinson’s disease

“…Прамипексол снижает длительность периода «выклю-чения» на 15-31% (в абсолютном выражении -на 1,3-2,6 ч в сутки) [5,[23][24][25][26]. В целом эффектив-ность прамипексола при моторных флюктуациях сопоставима с эффектом ингибиторов катехол-О-метилтрансферазы (КОМТ) [27].…”

Shedding light into the role of BDNF in the pharmacotherapy of Parkinson's disease

“…48 Stimulation of remaining dopamine receptors represents a further therapeutic approach. To this regard, the D3 receptor-preferring agonist pramipexole, an appropriate choice for initial treatment of PD, 49,50 was found neuroprotective in the MPTP animal model of PD 51 at clinically suitable dosing regimen, as measured by recovery of striatal TH-and DAT immunoreactivity that was significantly reduced in MPTP-treated mice. Presgraves et al 52 suggest that, in vitro, the neuroprotective action of pramipexole is mediated by BDNF since antibodies against the neurotrophin blocked the protection afforded by the D3 agonist.…”

Hipersexualidad asociada a pramipexol, en el tratamiento de síntomas parkinsonianos: revisión de la literatura, a propósito de 3 casos

“…Tiene una vida media plasmática de 8 a 12 horas y su vía de eliminación es renal. El pramipexol, al actuar selectivamente sobre receptores dopaminérgicos, presenta una menor proporción de efectos secundarios autonómicos, cardiovasculares y digestivos -como náuseas y vómitos, dispepsia, hipotensión ortostática, somnolencia y alucinaciones visuales-que otros AD ergóticos (12,13) . Los DCI, como la ludopatía y la hipersexualidad, han sido relacionados con el uso de AD en general, sin que se haya encontrado diferencias consistentes entre fármacos de este grupo, ni en su asociación con otros fármacos; tampoco se ha demostrado un efecto dosis dependiente.…”