Efficacy of pramipexole, a novel dopamine agonist, as monotherapy in mild to moderate Parkinson's disease

Abstract

A total of 335 patients with early Parkinson's disease (PD) were enrolled in a multicenter, randomized, double-blind trial designed to assess the efficacy and safety of pramipexole. Entry was restricted to patients with idiopathic PD who were not receiving levodopa. Pramipexole was administered according to an ascending dose schedule up to 4.5 mg/d. During the 7-week dose-escalation phase, each subject was titrated to his or her maximally tolerated dose of study medication. This was followed by a 24-week period of maintenance therapy. The mean daily dose during the maintenance period was 3.8 mg. Pramipexole significantly reduced the severity of PD symptoms and signs compared with placebo, as measured by decreases in parts II (Activities of Daily Living) and III (Motor Examination) of the Unified Parkinson's Disease Rating Scale at week 24 compared with baseline (p < or = 0.0001). Differences between the active drug and placebo groups emerged at week 3 (1.5 mg/d) in the ascending-dose interval and persisted throughout the maintenance phase (p < or = 0.0001). The majority of patients completed the study (pramipexole 83%, placebo 80%). In the assessment of adverse events, nausea, insomnia, constipation, somnolence, and visual hallucinations occurred more frequently in the pramipexole treatment group compared with placebo patients. No clinically significant changes were noted in blood pressure or pulse rate. Overall, these results indicate that pramipexole is safe and effective in the treatment of early PD.

The scientific and clinical basis for the treatment of Parkinson disease (2009)

“…Prospective, double-blind studies clearly demonstrate the superiority of monotherapy with pramipexole, ropinirole, pergolide, or cabergoline compared with placebo with respect to motor efficacy. 311,[328][329][330][331] Few studies have directly compared dopamine agonists with levodopa as monotherapy. A 6-month interim analysis of a 5-year, double-blind study demonstrated that patients randomized to receive treatment with ropinirole had clinical benefits that were only slightly inferior to those randomized to levodopa (44% vs 32% improvement).…”

Current Status of Symptomatic Medical Therapy in Parkinson’s Disease

“…For pramipexole, Shannon et al 56 found a 2.2-point improvement in the Activities of Daily Living (ADL) score over placebo and a 6-point improvement in the Motor score over placebo, both of which were statistically significant and maintained for the entire 6 months with a mean dose of 3.8 mg. More than 80% of participants completed the study. The most common adverse events included nausea (39%), insomnia (25.6%), constipation (17.7%), and somnolence (18.3%); these were significantly more common with active therapy than with placebo.…”

Capacities of the dopamine receptor agonist pramipexole in the treatment of patients with Parkinson’s disease

“…• отсрочить необходимость назначения леводопы (50-60% больных, получающих прамипексол, не нуждают-ся в леводопе к концу 3-го года монотерапии) [13,22].…”