Pramipexole is a novel, internationally available selective nonergot D2
dopamine agonist. The effectiveness, tolerability, and safety of
pramipexole have been extensively proven in controlled trials in patients in the early and advanced stage of
Parkinson's disease as monotherapy and in combination with
L dopa. These trials indicated specific activity against
tremor,
anhedonia, and depression. Therefore, the present prospective, multicenter postmarketing surveillance study evaluated for the first time to what extent the results from the controlled
pramipexole trials could be replicated under routine conditions in neurological practice and clinics. Modern scales were applied for the assessment of
tremor and mood, i.e., the Short Parkinson's Evaluation Scale (SPES), the
Tremor Impact Scale (TIS), and the German version of the Snaith-Hamilton Pleasure Scale (SHAPS-D). In 298 German Centers, 657 Parkinson's patients (365 men, 292 women) in advanced disease stages were treated with
pramipexole in combination with
levodopa. The average ages (+/- SD) were 67 (+/- 8.9) years for men and 69 (+/- 9.4) years for females. Motor functioning, especially
tremor, motor complications, depression, and
activities of daily living improved highly significantly (P < 0.0005), including self-rating by the patients. The dosage of
levodopa could be reduced on average by 8% (P < 0.0001). This might contribute to a slowing of the
disease progression in the long run. Dropouts due to side effects were observed only in 3.5% of the patients. Using new assessment scales suitable for routine application allowed confirmation of the results from controlled clinical trials with regard to
tremor,
anhedonia, and depression. The average daily dosage of
pramipexole prescribed was 1.05 mg and thus was definitely lower than the average daily dosages of 2.35-2.66 mg used in controlled trials. This signifies that the option to adjust dosage according to effectiveness and tolerability under routine conditions yields a considerably lower incidence of adverse effects.