Print

Print


6th International Congress of Parkinson's Disease and Movement Disorders
June 13, 2000

Clinical trials in Parkinson's disease: new releases

Ropinirole vs l-dopa in early Parkinson's disease: the randomized controlled
056 study

O. Rascol (Toulouse, F)

This prospective, randomised, double-blind, parallel-group study compared
the long-term safety and efficacy of ropinirole, a D2 dopamine agonist, with
L-dopa (MADOPARâ) over 5 years in 268 early de novo PD patients. Patients
with insufficient therapeutic benefit could supplement double-blind
medication with open L-dopa. 34% of were 16.5mg (SD 6.6) ropinirole and
427.2mg (SD 220.8) adjunct open L-dopa. In the L-dopa group, the dose was
753.3mg (SD 397.5). The incidences of dyskinesias in the ropinirole and
L-dopa groups, regardless of whether adjunct open L-dopa, were 20% and 46%,
respectively (odds ratio 3.8, 95% CI [2.1, 6.9], P<0.0001. The mean ADL
scores in both groups remained similar to each other at each timepoint
during the study. Forty-eight (27%) ropinirole patients and 26 (29%) L-dopa
patients withdrew from the study prematurely as a result of adverse
experiences. These adverse experiences were typical for dopaminergic agents
These results show that patients with early PD are successfully managed on
ropinirole with a low dose of adjunct L-dopa added later, for up to 5 years.
The risk of developing dyskinesias was substantially reduced in patients
receiving ropinirole, compared to those treated with L-dopa from the outset.