Trenkwalder, Claudia

[["dc.bibliographiccitation.firstpage","1785"],["dc.bibliographiccitation.issue","19"],["dc.bibliographiccitation.journal","Neurology"],["dc.bibliographiccitation.lastpage","1793"],["dc.bibliographiccitation.volume","86"],["dc.contributor.author","Bauer, Axel"],["dc.contributor.author","Cassel, Werner"],["dc.contributor.author","Benes, Heike"],["dc.contributor.author","Kesper, Karl"],["dc.contributor.author","Rye, David"],["dc.contributor.author","Sica, Domenic"],["dc.contributor.author","Winkelman, John W."],["dc.contributor.author","Bauer, Lars"],["dc.contributor.author","Grieger, Frank"],["dc.contributor.author","Joeres, Lars"],["dc.contributor.author","Moran, Kimberly"],["dc.contributor.author","Schollmayer, Erwin"],["dc.contributor.author","Whitesides, John"],["dc.contributor.author","Carney, Hannah C."],["dc.contributor.author","Walters, Arthur S."],["dc.contributor.author","Oertel, Wolfgang"],["dc.contributor.author","Trenkwalder, Claudia"],["dc.date.accessioned","2018-11-07T10:14:18Z"],["dc.date.available","2018-11-07T10:14:18Z"],["dc.date.issued","2016"],["dc.description.abstract","Objective: This double-blind, placebo-controlled, interventional trial was conducted to investigate the effects of rotigotine patch on periodic limb movement (PLM)-associated nocturnal systolic blood pressure (SBP) elevations. Methods: Patients with moderate to severe restless legs syndrome (RLS) were randomized to rotigotine (optimal dose [1-3 mg/24 h]) or placebo. Continuous beat-to-beat blood pressure (BP) assessments were performed during polysomnography at baseline and at the end of 4-week maintenance. Primary outcome was change in number of PLM-associated SBP elevations (defined as slope of linear regression >= 2.5 mm Hg/beat-to-beat interval over 5 consecutive heartbeats [>= 10 mm Hg]). Additional outcomes were total SBP elevations, PLM-associated and total diastolic BP (DBP) elevations, periodic limb movements index (PLMI), and PLM in sleep arousal index (PLMSAI). Results: Of 81 randomized patients, 66 (37 rotigotine, 29 placebo) were included in efficacy assessments. PLM-associated SBP elevations were significantly reduced with rotigotine vs placebo (least squares mean treatment difference [95% confidence interval (CI)] -160.34 [-213.23 to -107.45]; p < 0.0001). Rotigotine-treated patients also had greater reduction vs placebo in total SBP elevations (-161.13 [-264.47 to -57.79]; p = 0.0028), PLM-associated elevations (-88.45 [-126.12 to -50.78]; p < 0.0001), and total DBP elevations (-93.81 [-168.45 to -19.16]; p = 0.0146), PLMI (-32.77 [-44.73 to -20.80]; p < 0.0001), and PLMSAI (-7.10 [-11.93 to -2.26]; p = 0.0047). Adverse events included nausea (rotigotine 23%; placebo 8%), headache (18% each), nasopharyngitis (18%; 8%), and fatigue (13%; 15%). Conclusions: Further investigation is required to determine whether reductions in nocturnal BP elevations observed with rotigotine might modify cardiovascular risk. Classification of evidence: This study provides Class I evidence that for patients with moderate to severe RLS, rotigotine at optimal dose (1-3 mg/24 h) reduced PLM-associated nocturnal SBP elevations."],["dc.description.sponsorship","UCB, Monheim am Rhein, Germany"],["dc.identifier.isi","000382000000010"],["dc.identifier.pmid","27164714"],["dc.identifier.uri","https://resolver.sub.uni-goettingen.de/purl?gro-2/40596"],["dc.notes.status","zu prüfen"],["dc.notes.submitter","Najko"],["dc.publisher","Lippincott Williams & Wilkins"],["dc.relation.issn","1526-632X"],["dc.relation.issn","0028-3878"],["dc.title","Rotigotine's effect on PLM-associated blood pressure elevations in restless legs syndrome An RCT"],["dc.type","journal_article"],["dc.type.internalPublication","yes"],["dc.type.peerReviewed","yes"],["dc.type.status","published"],["dspace.entity.type","Publication"]]