A 3-year randomized trial of ropinirole and bromocriptine in early Parkinson's disease. The 053 Study Group.
OBJECTIVE
To compare the long-term efficacy and safety of ropinirole with bromocriptine over 3 years in patients with early PD with limited or no previous dopaminergic therapy.


METHODS
In this prospective, double-blind, parallel-group study, 335 patients were randomized to 0.75 mg ropinirole or 1.25 mg bromocriptine titrated upward at weekly intervals--maximum permitted daily doses were 24 mg ropinirole, 40 mg bromocriptine.


RESULTS
Approximately one third of patients in each group withdrew prematurely, mostly because of adverse experiences; 61/102 (60%) of ropinirole-treated and 59/112 (53%) of bromocriptine-treated patients completed the study on the dopamine agonist alone. Mean doses for all patients at completion were 12 mg (SD 6) ropinirole and 24 mg (SD 8) bromocriptine. Occurrence of adverse experiences in both groups was similar. Emergence of dyskinesias was low. Both treatments induced marked improvements in Unified Parkinson's Disease Rating Scale activities of daily living (ADL, Part II) and motor (Part III) scores over the first 12 weeks, which were maintained during the study. After 3 years, patients in the ropinirole group had a mean improvement in motor score of 31% compared with 22% in the bromocriptine group (p = 0.086) and a significantly better ADL score (treatment difference 1.46 points, p = 0.009) [corrected].


CONCLUSIONS
Both dopamine agonists are effective in the early treatment of a high proportion of PD patients; effectiveness persists for at least 3 years. Those who completed the study had a significantly better functional status on ropinirole than on bromocriptine.
Korczyn
A D
AD
Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Israel. neuro13@ccsg.tau.ac.il
Brunt
E R
ER
Larsen
J P
JP
Nagy
Z
Z
Poewe
W H
WH
Ruggieri
S
S
D000203:Activities of Daily Living; D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D001971:Bromocriptine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D013997:Time Factors
D000978:Antiparkinson Agents; D007211:Indoles; C046649:ropinirole; D001971:Bromocriptine; D007980:Levodopa