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Neupro® (Rotigotine) Provided Clinically Relevant Improvements in Health-Related Quality of Life for People with Parkinson's Disease
Date:9/30/2010

all, 0.50 moderate, and 0.80 large effect). In the placebo group, the effect size (-0.06) and standardized response mean (-0.09) were low.

In a study of Asian patients, the PDQ-8 minimal important difference (MID) – defined as the smallest difference in score that informed patients/proxies would perceive as important and would lead the patient or clinician to consider a change in therapy – has been shown to range from 5.8-7.4 points.

"The change from baseline in PDQ-8 score in the rotigotine group was within the previously established MID range, suggesting that patients in the current study would consider the improvement in HRQL achieved by rotigotine to be important. The effect sizes indicate that the PDQ-8 is a responsive instrument and that rotigotine has a clinically relevant effect on HRQL," concluded Mr. Lilliu.

In the RECOVER study, the most frequently reported adverse events were nausea (rotigotine 21%, placebo 9%), application site reactions (rotigotine 15%, placebo 4%), and dizziness (rotigotine 10%, placebo 6%). In general, adverse drug reactions reported in more than 10% of Parkinson's patients treated with Neupro® are nausea, vomiting, application site reactions, somnolence, dizziness and headache.

Preclinical data showed rotigotine increased depth of sleep in ratsPreclinical data presented at the Congress showed that continuous administration of rotigotine or pulsatile L-DOPA had beneficial effects on wakefulness and sleep patterns in a rat model of Parkinson's disease, but only continuous rotigotine decreased the ratio of alpha to delta wave sleep during slow wave sleep, indicative of increased depth of sleep. To date the clinical significance of this finding has not been established.

The study was carried out to investigate the effects of rotigotine and pulsatile L-DOPA on sleep-wake patterns in a preclinical rat model of Parkinson's disease.

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