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PMID: 9579296: Ropinirole as monotherapy in PD


A placebo-controlled evaluation of ropinirole, a novel D2 agonist,
as sole dopaminergic therapy in Parkinson's disease.

The efficacy and safety of ropinirole, a novel nonergot dopamine D2-like 
receptor agonist, was assessed as monotherapy for the treatment of patients 
with early-stage Parkinson's disease.

In this double-blind, multicenter trial, patients were randomly allocated in a 
ratio of 2:1 to receive, over a 12-week period, either ropinirole or placebo.

Clinical status was assessed using the Unified Parkinson's Disease Rating Scale 
(UP-DRS), Clinician's Global Evaluation (CGE), and a finger-tapping score.

In all, 41 patients received ropinirole and 22 received placebo.

The end-point analysis, on an intention-to-treat basis, revealed a significant 
difference (p = 0.018) in improvement in UP-DRS motor score from baseline 
between treatment groups (ropinirole, 43.4%; and placebo, 21.0%).

Other parameters, including the number of responders and improvement in CGE, 
showed similar results.

Three patients in the ropinirole group and one patient in the placebo group 
discontinued the study because of adverse events. There was no significant 
difference between the treatment groups in the overall incidence of adverse 
events.

Although the dopaminergic side effects were reported significantly more 
frequently in the ropinirole group than in the placebo group (dizziness, p = 
0.0326; nausea, p = 0.001; and somnolence, p = 0.005), none necessitated study 
withdrawal.

There was no evidence of any chronic effect of the study medication on vital 
signs.

In conclusion, ropinirole is a safe and well-tolerated drug and, as 
monotherapy, provided significant therapeutic benefit compared with placebo to 
patients in the early stages of Parkinson's disease.


Clin Neuropharmacol 1998 Mar-Apr;21(2):101-7
Brooks DJ, Abbott RJ, Lees AJ, Martignoni E,
Philcox DV, Rascol O, Roos RA, Sagar HJ
Department of Neurology, Hammersmith Hospital, London, U.K.
PMID: 9579296, UI: 98240459

<>

janet paterson
52 now / 41 dx / 37 onset
snail-mail: PO Box 171  Almonte  Ontario  K0A 1A0  Canada
website: a new voice <>
e-mail: <janet313@xxxxxxxxxxx>


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