EARLY TREATMENT OF PARKINSONS-DISEASE WITH CABERGOLINE DELAYS THE ONSET OF MOTOR COMPLICATIONS - RESULTS OF A DOUBLE-BLIND LEVODOPA CONTROLLED TRIAL

This multicentre randomised double-blind 3- to 5-year trial was design ed to assess whether initial therapy with cabergoline alone or in comb ination with levodopa prevents or delays the occurrence of long term m otor complications in patients with early Parkinson's disease. Patient s eligible for study inclusion (n = 412) had early idiopathic Parkinso n's disease (Hoehn and Yahr stages 1 to 3) and had received no previou s treatment with levodopa, selegiline or dopamine agonists. Patients w ere randomised to receive either cabergoline (0.25 to 4mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 w eeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications con firmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms wh en the improvement in motor disability [Unified Parkinson's Disease Ra ting Scale (UPDRS) factor III] decreased below 30% vs baseline. Both t reatments improved motor disability, decreasing UPDRS factor III score s and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34%; p < 0.02). The relative risk of developing motor complications d uring treatment with cabergoline was more than 50% lower than with lev odopa. Serious adverse events, either drug related or not, were slight ly more frequent in cabergoline-treated patients (31%) than in those t reated with levodopa (25%). The withdrawal rate in the cabergoline vs levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective eith er as monotherapy or combined with levodopa. Moreover, starting treatm ent with cabergoline significantly delays the development of motor com plications.