Ropinirole for the treatment of early Parkinson disease: a 12-month experience. Ropinirole Study Group.
OBJECTIVE
To evaluate ropinirole hydrochloride as dopaminergic monotherapy in patients with early Parkinson disease.


METHODS
A 6-month extension of a double-blind, placebo-controlled study.


METHODS
Ambulatory care at 22 different sites in the United States.


METHODS
Patients who successfully completed the initial 6-month study could enter the 6-month extension study (ropinirole, n = 70; placebo, n = 77).


METHODS
Use of ropinirole or placebo therapy.


METHODS
The efficacy variables were the number of patients who successfully completed the 12-month study and did not require supplemental levodopa, the number of patients requiring supplemental levodopa, and the proportion of patients having an insufficient therapeutic response.


RESULTS
Significantly fewer ropinirole-treated patients met criteria for insufficient therapeutic response (23 [19.8%] of 116) or required the initiation of levodopa therapy (22 [19%] of 116) compared with placebo-treated patients (60 [48%] of 125 patients for insufficient therapeutic response; 57 [45.6%] of 125 patients for additional levodopa). Significantly more ropinirole-treated patients (51 [44.0%] of 116) successfully completed the 12-month study and did not require supplemental levodopa compared with placebo-treated patients (28 [22.4%] of 125). The incidence of adverse experiences and patient withdrawals was low.


CONCLUSIONS
Ropinirole was effective and well tolerated as monotherapy for 12 months in patients with early Parkinson disease.
Sethi
K D
KD
Department of Neurology, Medical College of Georgia, Augusta 30912, USA.
O'Brien
C F
CF
Hammerstad
J P
JP
Adler
C H
CH
Davis
T L
TL
Taylor
R L
RL
Sanchez-Ramos
J
J
Bertoni
J M
JM
Hauser
R A
RA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care; D000978:Antiparkinson Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D016896:Treatment Outcome; D014481:United States
D000978:Antiparkinson Agents; D007211:Indoles; C046649:ropinirole