Neupro Shows Promise For Restless Legs Syndrome Patients
Neupro® (rotigotine) is approved in the E.U. as a symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults, and for treating signs and symptoms of early-stage idiopathic Parkinson's disease, either as monotherapy or in combination with levodopa over the course of the disease through to late stages, when the effect of levodopa wears off or becomes inconsistent, and end of dose or on-off fluctuations of the therapeutic effect occur.
Neupro® is also approved in the European Union.
The researchers gathered "real-life" data on 687 adult patients with RLS who were administered with Neupro®. The results of the large, 3-months long, non-interventional, observational study indicated that the effects seen in placebo-controlled clinical trials were reflected in daily clinical practice and that the finding and that they were consistent with the clinical analysis from the pivotal trials.
Dr Cornelius Bachmann from the Georg August University in Göttingen, Germany, declared: "The efficacy, safety and tolerability profile of rotigotine transdermal patch has been documented in several placebo-controlled trials. This observational study examined the effects of rotigotine transdermal patch on RLS symptoms in the real world, and indicated that it was effective in daily clinical practice."
To establish the severity profile of different day- and night-time symptoms of RLS across six factors, the researchers used the validated RLS-6 11-point scale to measure Neupro's efficacy. The scale ranged from 0 = not present to 10 = very severe, and measurements were taken at the beginning of the study, during an interim visit and at the end of the treatment.
The researchers defined the second and third factor, i.e. improvement in symptom severity when falling asleep and improvement in symptom severity during the night, as primary variables.
The longest duration of the average rotigotine transdermal patch dose was 2.4mg/24hr in 564 patients with sufficient data for the efficacy evaluation. At the end of the therapy the researchers were able to assess the treatment's efficacy in individual factors of 501 patients.
At the start of the study, 57.8% of patients reported frequent RLS symptom onset during the day and the findings revealed that rotigotine transdermal patch improved the day- and night-time symptoms, which were defined as an average reduction in all individual RLS-6 factor scores. The results for the individually tested factors showed that 70.5% of patients (n=501) reported an improvement in sleep satisfaction (Factor 1), whilst 67.9% patients (n=501) said the symptom severity improved when falling asleep (Factor 2). 500 patients or 69.6% said their symptom severity improved during the night (Factor 3), whilst 74.7% (n=499) patients reported that the severity of the symptoms improved during the day when they were at rest (Factor 4). During daytime activity (Factor 5), 43.9% or 501 patients reported an improvement in symptom severity whilst 68.5% (n=498) stated they felt less sleepy or tired during the day (Factor 6).
1% or more patients experienced adverse treatment-related events, which included skin reactions (10.4%), nausea (5.7%), dizziness (2.8%), headache (2.8%), fatigue (2.0%), sleep disorder (1.2%) and hypertension (1.0%). Most adverse events were of mild to moderate intensity.
Click here to go the European Summary of Product Characteristics for full prescribing information (Revised August 2011).
Written by Petra Rattue