Neupro improves quality of life in Parkinson's disease patients

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Reviewed

UCBOct 4 2010

People with Parkinson's disease who used once-daily Neupro® (rotigotine) in the RECOVER trial achieved improvements in quality of life, in addition to previously reported beneficial effects on motor and non-motor symptoms.

Data presented this week at the 2nd World Parkinson Congress in Glasgow, UK, showed that Neupro® provided clinically relevant improvements in PDQ-8 score. This is a self-administered health-related quality of life questionnaire (HRQL) for Parkinson's disease comprising eight items – mobility, activities of daily living, emotional well-being, social support, cognition, communication, bodily discomfort and stigma.

"Data from the RECOVER trial demonstrated improvements in motor and non-motor symptoms for people living with Parkinson's disease as well as worthwhile changes in the quality of their everyday lives, including their daily activities, their emotional well being and their cognitive and communication abilities," said Herve Lilliu, Head of Health Outcomes and Access, UCB.

The RECOVER trial was a multicenter, multinational, double-blind, placebo-controlled study designed to assess the effects of rotigotine in controlling early morning motor function and non-motor symptoms that affect the everyday lives of people with early- and late-stage Parkinson's disease. Patients were randomized (2:1) to receive rotigotine (2-16 mg/24 h) or placebo during a titration period lasting up to 8 weeks, followed by a 4-week maintenance period.

PDQ-8 data were obtained from measurements taken at baseline and at the end of the 12 week study from 89 placebo- and 176 rotigotine-randomized patients. Mean change from baseline PDQ-8 total score was greater in the rotigotine group (-6.9 [SD: 11.9]) than the placebo group (-1.2 [SD: 13.7]; p<0.001). Both the rotigotine effect size (-0.41) and standardized response mean (-0.58) were moderate based on the Cohen definition of change (0.20 small, 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 rotigotineincreased depth of sleep in rats

Preclinical 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.

After two days of baseline recording, the study compared the effects of rotigotine administered as a slow-release formulation of 0.5 or 5 mg/kg every second day for 6 days and L-DOPA/benserazide administered daily at 10/7.5 mg/kg s.c., for 6 days in 6-OHDA lesioned rats.

Latency to slow wave sleep (SWS) and paradoxical sleep (REM) onset, duration of waking, SWS and REM sleep and the alpha and delta frequency ratio during SWS were analyzed off-line. No effects were seen with low dose rotigotine or with a placebo vehicle. Pulsatile L-DOPA and continuous rotigotine at 5 mg/kg caused an increase in active waking and a decrease in SWS duration. While L-DOPA had no effect on the alpha/delta power ratio, the high dose of continuous rotigotine decreased the alpha/delta ratio towards an increase in delta power during SWS.

Other UCB sponsored presentations at the 2nd World Parkinson Congress

Fresh insights into the lives of people living with Parkinson's disease, and their differing needs for information and support were reported in analyses sponsored by UCB and presented at the Congress:

Lindvall S, Graham L, O'Brien E, Davis U. A Qualitative Assessment of the Educational and Support Needs of People Living with Parkinson's Disease
Verhaeghe A. & Elleboudt L. Learning from Online Discussions about Parkinson's Disease Amongst People with Parkinson's and Their Carers
Wullner U, Fuchs G, Reketat N, Randerath O, Kassubek J. Pharmacotherapy for Parkinson's Disease — Patients' Priorities

Data from a retrospective cohort study, also presented at the Congress, investigated the clinical and health economic impact of gastrointestinal disorders in patients with Parkinson's disease: