EFFICACY OF PRAMIPEXOLE, A NOVEL DOPAMINE AGONIST, AS MONOTHERAPY IN MILD-TO-MODERATE PARKINSONS-DISEASE

A total of 335 patients with early Parkinson's disease (PD) were enrol led in a multicenter, randomized, double-blind trial designed to asses s the efficacy and safety of pramipexole. Entry was restricted to pati ents with idiopathic PD who were not receiving levodopa. Pramipexole w as administered according to an ascending dose schedule up to 4.5 mg/d . During the 7-week dose-escalation phase, each subject was titrated t o his or her maximally tolerated dose of study medication. This was fo llowed by a 24-week period of maintenance therapy. The mean daily dose during the maintenance period was 3.8 mg. Pramipexole significantly r educed the severity of PD symptoms and signs compared with placebo, as measured by decreases in parts II (Activities of Daily Living) and II I (Motor Examination) of the Unified Parkinson's Disease Rating Scale at week 24 compared with baseline (p less than or equal to 0.0001). Di fferences between the active drug and placebo groups emerged at week 3 (1.5 mg/d) in the ascending-dose interval and persisted throughout th e maintenance phase (p less than or equal to 0.0001). The majority of patients completed the study (pramipexole 83%, placebo 80%). In the as sessment of adverse events, nausea, insomnia, constipation, somnolence , and visual hallucinations occurred more frequently in the pramipexol e treatment group compared with placebo patients. No clinically signif icant changes were noted in blood pressure or pulse rate. Overall, the se results indicate that pramipexole is safe and effective in the trea tment of early PD.