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Ropinirole Effective in Reducing Nocturnal Symptoms in Advanced Parkinson's Disease Not Optimally Controlled With L-dopa: Presented at EFNS

By Ann Saul

FLORENCE, Italy -- September 16, 2009 -- Nocturnal symptoms in patients with advanced Parkinson's disease (PD) not optimally controlled with levodopa (L-dopa) may be reduced by once daily treatment with prolonged release ropinirole, according to a study presented here at the 13th Congress of the European Federation of Neurological Societies (EFNS).

K. Ray Chaudhuri, National Parkinson Foundation Center of Excellence, Kings College Hospital, University Hospital Lewisham, United Kingdom, presented the findings of a post hoc analysis of data from the Efficacy and Safety Evaluation in Parkinson's Disease (EASE-PD) Adjunct study on September 14.

Previous studies have demonstrated the effectiveness of ropinirole in improving symptom control and reducing motor complications. The current analysis shows ropinirole to be effective at reducing nocturnal symptoms, suggesting that it may provide 24-hour symptom control in patients with advanced PD not optimally controlled with L-dopa.

The EASE-PD Adjunct study was a multicentre, double-blind, parallel-group, placebo-controlled, 24-week, phase 3 trial in which patients were randomised to once-daily ropinirole prolonged release or placebo.

For the post hoc analysis, the Parkinson's Disease Sleep Scale (PDSS) was used to evaluate nocturnal symptoms in study participants.

PDSS total score and all PDSS group scores were improved at weeks 12 and 24 observed case and 24 last observation carried forward (LOCF) for patients with baseline PDSS score <=100. At week 24 LOCF, the mean (SD) change from baseline in PDSS total score for ropinirole prolonged release was 10.3 (24.4) versus 2.5 (20.96) for placebo.

The group analyses also showed treatment benefits at week 24 LOCF for ropinirole prolonged release over placebo, including: nocturnal restlessness (1.5 [5.89] vs 1.1 [5.37]); nocturnal "off" periods (4.1 [9.22] vs 0.3 [9.08]); daytime sleepiness (0.9 [5.58] vs -0.3 [5.34]); dopaminergic symptoms (7.5 [16.26] vs 2.3 [14.98]); and global quality of nocturnal sleep (2.1 [7.41] vs 0.2 [6.76]).

Patients who had suffered significant nocturnal symptoms at baseline experienced significantly greater improvement in total PDSS score with ropinirole prolonged release versus placebo, with no worsening of nocturnal psychosis.

Funding for this study was provided by GlaxoSmithKline R&D and SkyePharma.

[Presentation title: Nocturnal Symptoms Are Improved With Ropinirole Prolonged Release in Patients With Advanced Parkinson's Disease (PD) With Significant Night-Time Symptoms Not Optimally Controlled With L-dopa. Abstract 2548]

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