UCB today announced data from a double-blind, placebo-controlled study that found that Neupro® (Rotigotine Transdermal System) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate-to-severe Restless Legs Syndrome (RLS)/Willis-Ekbom disease. The data was presented at the Annual Scientific Meeting of the American Society of Hypertension, May 15-18, 2013.
The data showed that rotigotine reduces PLMS and associated total nocturnal systolic blood pressure (NSBP) elevations in patients with RLS. Research has found that episodic nocturnal blood pressure excursions coincide with PLMS, possibly increasing the risk of hypertension and cardiovascular disease.
Neupro® is approved in the U.S. for the treatment of moderate-to-severe primary RLS. Neupro® is also approved in the European Union for the symptomatic treatment of moderate-to-severe idiopathic RLS in adults.
"Our understanding of the extent to which RLS affects health is broadening. We are increasingly becoming aware of new organ systems that interact with this complex neurological disorder, going beyond symptoms of leg discomfort. The association of RLS with cardiovascular risk suggests that this disorder has unintended bed fellows," said Dr. David Rye , MD, PhD, Professor of Neurology, Emory University School of Medicine. "The data demonstrate the potential impact of Neupro® upon nocturnal blood pressure elevations that coincide with periodic limb movements, a sign present in nearly all RLS patients. These findings beg for additional research into the pathophysiological underpinnings of this association and the potential new vistas it suggests into the control and treatment of both cardiovascular disease and RLS."
RLS is an often misdiagnosed and undertreated condition that affects an estimated 23 million Americans. PLMS occur in up to 90% of patients with RLS, and autonomic activation, associated with PLMS, has been linked to blood pressure increases in these RLS patients.
The study randomized 81 RLS patients (1:1) to receive an optimal dose of rotigotine (1mg/24hr, 2mg/24hr, or 3mg/24hr) or placebo. Continuous beat-by-beat blood pressure and heart rate assessments were performed at baseline and at the end of 4-week maintenance. The primary outcome was a change from baseline to end of maintenance in the number of NSBP elevations associated with PLMS. Change from baseline in total NSBP elevations and PLM index (PLMI) were also assessed.
Of the 66 RLS patients who completed the study, 37 received rotigotine and 29 received placebo. Mean (+SD) baseline PLMI was similar between rotigotine (72.9+55.6) and placebo (69.9+47.9). Patients with PLM-associated NSBP elevations (~300 elevations at baseline) saw greater reductions with rotigotine versus placebo. Total NSBP elevations (~785 elevations) decreased more in patients using rotigotine versus placebo. Rotigotine users also experienced greater decreases from baseline to end of maintenance in PLMI versus placebo. These results indicate that rotigotine reduced PLM-associated and total NSBP elevations in patients with RLS. Adverse events were consistent with dopaminergic stimulation and transdermal application. A total of 15 patients (rotigotine: 4/40; placebo: 11/41) discontinued prematurely.