Patch form of dopamine agonist also lowered nighttime activity
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SAN DIEGO -- The rotigotine patch (Neupro) appeared to objectively improve sleep quality in patients with Parkinson's disease with self-reported sleep complaints, Italian researchers said here.
Based on actigraph recordings, overall sleep efficiency was 67.8% in the week before treatment and 73.4% after 4 weeks of treatment with rotigotine patches for a statistically significant difference (P=0.017), according to Federica Provini, MD, of the University of Bologna, and colleagues.
In a poster presentation at Movement Disorders Society annual meeting, Provini's group noted that rotigotine is a dopamine agonist used for the treatment of motor symptoms in Parkinson's disease (PD) patients. Previous reports have suggested rotigotine use led to improvements in subjective sleep in PD patients with sleep complaints.
What was different in this pilot study was that the researchers used the actigraph, which records what really happens during sleep, to confirm the effectiveness of the patches.
"This is the first objective demonstration of rotigotine during sleep," said co-author Pietro Cortelli, MD, also at the University of Bologna. "Our study relied on the actigraph, not on questionnaires. The patients wore the actigraph 1 week before we treated, then we had the recording done after 4 weeks of treatment with rotigotine patches."
Cortelli told MedPage Today that the authors sought to show that the patches had an impact on the patient's sleep only. "We were not trying to determine if the patches improved motor function efficacy. We did not have a placebo group. We were just measuring their sleep efficiency," he said.
The patients were assessed using the Parkinson's Disease Sleep Scale, the Epworth Sleepiness Scale and the restless leg syndrome rating scale before the treatment. Their sleep was recorded with the actigraph to provide baseline data. The actigraph used was the Mini Motionlogger Actigraph Advanced by Ambulatory Monitoring.
Twelve of the 15 patients in the study were men and the mean age of all the participants was 67. They had been diagnosed with Parkinson's disease for a mean of 5 years. To be eligible for the study, the patients had to have registered sleep complaints and scored 10 or greater on the Parkinson's Disease Sleep Scale-2; a 3 or greater on the Hoehn and Yahr Score; and, prior to the study, could not have undergone treatment with rotigotine to control motor symptoms.
After 1 week without treatment, patients were treated with a 24-hour patch which was titrated over 1-4 weeks to the optimal dose to subjectively control motor symptom control. The starting patch contained 2 mg of rotigotine and the highest dose patch was 8 mg of rotigotine which was absorbed through the skin in 24 hours.
In addition to sleep efficiency, Provini told MedPage Today that there was a significant reduction in wake after sleep onset time (P=0.013). The wake after sleep onset time was 147.5 minutes in the week before using the patch and 106.5 minutes after the 1-month treatment trial, the researchers said. A longer wake after sleep onset is considered less efficient sleep quality.
The researcher also reported a reduction in the mean duration of wake episodes (P=0.005); improvement in the Unified Parkinson's Disease Rating Scale-III (P=0.018), and in the Parkinson's Disease Sleep Scale (P=0.005).
When looking at the patients who had pathological sleep efficiency pre-treatment, the authors reported a significant reduction in the nighttime activity mean (P=0.005) and activity median (P=0.04) post-treatment.
"This pilot study suggests that rotigotine subjectively improves sleep quality and [quality of life] in PD patients with self-eported sleep complaints and induces a significant reduction in nighttime activity, which could contribute to compromised sleep," the authors wrote, adding that in patients with reduced sleep efficiency, rotigotine objectively improved all sleep parameters.
Cortelli and Provini disclosed no relevant relationships with industry.
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