Ropinirole for the treatment of early Parkinson's disease. The Ropinirole Study Group.
A prospective, randomized, placebo-controlled, double-blind, parallel-group, 6-month study assessed the efficacy and safety of ropinirole, a nonergoline D2-dopamine agonist, in patients with early Parkinson's disease (n = 241; Hoehn & Yahr stages I to III) with limited or no prior dopaminergic therapy. Patients (mean age, 62.8 years), stratified by concomitant use of selegiline, were randomized to ropinirole (n = 116) or placebo (n = 125). The starting dose of ropinirole was 0.25 mg tid with titration to at least 1.5 mg tid (maximum dose, 8 mg tid). Primary efficacy endpoint was the percentage improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score. Ropinirole-treated patients had a significantly greater percentage improvement in UPDRS motor score than patients who received placebo (+24% vs -3%; p < 0.001). Ropinirole was well tolerated and patient withdrawals were infrequent. Most adverse experiences were related to peripheral dopaminergic activity. Ropinirole monotherapy is an effective and well-tolerated therapeutic option for treatment of early Parkinson's disease.
Adler
C H
CH
Department of Neurology of the Mayo Clinic, Scottsdale, AZ 85259, USA.
Sethi
K D
KD
Hauser
R A
RA
Davis
T L
TL
Hammerstad
J P
JP
Bertoni
J
J
Taylor
R L
RL
Sanchez-Ramos
J
J
O'Brien
C F
CF
D000368:Aged; D000978:Antiparkinson Agents / Q000627:therapeutic use*; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000978:Antiparkinson Agents; D018491:Dopamine Agonists; D007211:Indoles; C046649:ropinirole