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Ropinirole for the Treatment of Early Parkinson Disease
A 12-Month Experience
K. D. Sethi, MD, FRCP(UK);
C. F. O'Brien, MD;
J. P. Hammerstad, MD;
C. H. Adler, MD, PhD;
T. L. Davis, MD;
R. L. Taylor, MD;
J. Sanchez-Ramos, MD;
J. M. Bertoni, MD, PhD;
R. A. Hauser, MD;
for the Ropinirole Study Group
Arch Neurol. 1998;55:1211-1216.
Objective To evaluate ropinirole hydrochloride as dopaminergic monotherapy in patients with early Parkinson disease.
Design A 6-month extension of a double-blind, placebo-controlled study.
Setting Ambulatory care at 22 different sites in the United States.
Patients Patients who successfully completed the initial 6-month study could enter the 6-month extension study (ropinirole, n=70; placebo, n=77).
Intervention Use of ropinirole or placebo therapy.
Main Outcome Measures 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.
Conclusion Ropinirole was effective and well tolerated as monotherapy for 12 months in patients with early Parkinson disease.
From the Departments of Neurology, Medical College of Georgia, Augusta (Dr Sethi); Colorado Neurological Institute, Englewood (Dr O'Brien); Oregon Health Sciences University, Portland (Dr Hammerstad); Mayo Clinic–Scottsdale, Scottsdale, Ariz (Dr Adler); Vanderbilt University Hospital, Nashville, Tenn (Dr Davis); Taylor Medical Group, Baltimore, Md (Dr Taylor); Miami Veterans Affairs Medical Center, Miami, Fla (Dr Sanchez-Ramos); Creighton University Medical Center, Omaha, Neb (Dr Bertoni); and University of South Florida, Tampa (Dr Hauser).
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