By Louise Gagnon
TORONTO — April 19, 2010 — Patients with Parkinson’s disease who are treated with 24-hour transdermal rotigotine as an adjunct therapy report improved symptoms with longer-term treatment, according to a study presented here at the 62nd Annual Meeting of the American Academy of Neurology (AAN).
Patients who participated in either the Prospective Randomized Evaluation of a New Formulation: Efficacy of Rotigotine (PREFER) study or the Clinical Efficacy of Pramipexole and Transdermal Rotigotine in Advanced PD (CLEOPATRA-PD) were invited to participate in 2 open-label extension studies.
Patients had Parkinson’ disease for at least 3 years and had no serious adverse events in the previous double-blinded studies.
In one extension study, the Unified Parkinson’s Disease Rating Scale (UPDRS) Part II Activities of Daily Living (ADL) mean total score improved from baseline of the double-blind study by -4.5 points during titration of the open-label phase, returning to baseline values over 4 years. Similarly, the mean UPDRS motor score improved from double-blind baseline by -10.1 points during titration, but resulted in -2.8 points in improvement.
In the other extension study, there was a -4.9-point mean improvement in the UPDRS ADL score that occurred during titration, but resulted in +4.1 points above baseline over 6 years. The mean UPDRS motor score changed from an initial -11.4 improvement to -0.2 points.
“The benefit is continued even though there is a worsening of the underlying disorder [Parkinson’s disease], which is typical,” said Peter A. LeWitt, MD, Parkinson Movement Disorder Program, at Henry Ford Hospital, Detroit, Michigan, on April 14. “The efficacy of the medication as a symptomatic therapy seems to continue over time. We see the same kinds of symptomatic relief that were seen earlier on [in the double-blind studies].”
Treatment-emergent adverse events were related to the dose, according to Dr. LeWitt, and included insomnia, dyskinesias, and hallucinations. The delivery of the medication as a patch favours tolerability, he added.
“There is not a peak effect because the medication is delivered transdermally,” said Dr. LeWitt. “It lessens the side effect profile of the medication. This drug can cause somnolence, but it is less prominent [than other similar agents]. In my clinical experience, I use this drug if the patient had a problem with somnolence with an oral medication.”
Funding for this study was provided by the UCB Group.
[Presentation title: Long-Term Treatment of Advanced Parkinson’s Disease With Rotigotine. Abstract P04.131]