Aims: Cabergoline (CBG), a long-acting ergoline derivative, is frequently used for the
add-on treatment of Parkinson's disease (PD).
Study Objectives: To assess the safety and efficacy of CBG for the first-line treatment of PD with
special regard to disease-/treatment-related sleep disturbances.
Design: open-label, long-term (52 weeks), multicentre observational trial.
Setting: 245 patients (44.9% female) with an age of 63.6±10.3yrs. and a diagnosis of early
idiopathic PD (mean disease duration was 13.0±17.8 mos.).
Intervention: CBG was uptitrated according to individual efficacy and tolerability effects.
Measurements: Safety and efficacy were assessed on the basis of standardized scores and questionnaires,
with special focus on sleep-disturbances.
Results: Overall 104 patients (42.5%) completed the observation period according to protocol
requirements after a mean treatment period of 231.7±165.9 days with a mean CBG dose
of 2.8±1.5mg. 18 patients discontinued prematurely and in 123 data beyond baseline
weren't available. At the end of the observation period consistent improvements vs.
baseline were seen in all evaluable parameters (UPDRS 2/3: 6.1.±5.6 / 9.3±6.5 vs.
8.6±6.3/13.8±7.4; capacity of daily living (Schwab & England): 82.8±13.7 vs. 87.2±11.7;
PD sleep scale (PDSS): 113.6±20.2 vs. 99.7±26.2; PDQ-39: 16.8±4.8 vs. 12.2±5.7) accompanied
by a significant decrease in sleep disturbances (19.4 vs. 42.9%, p<0.001). 9.8% of
patients reported treatment-related adverse events; most frequently dizziness/fatigue
(2.0/2.0%), peripheral oedema (1.2%), nausea (0.8%) and mood disturbances (0.8%).
Overall efficacy/tolerability was rated as very good by 50.2/67.5% and as good by
further 40.3/27.5%.
Conclusion: The early intervention with CBG as first-line treatment for PD proved to be a highly
efficacious and well tolerated alternative to the current standard levodopa. Sleep
disturbances – initially seen in over 40% of drug-nave patients – improved significantly
with CBG as well as all other PD-related restrictions.
