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Bauer, Axel; Cassel, Werner; Benes, Heike; Kesper, Karl; Rye, David; Sica, Domenic; Winkelman, John W.; Bauer, Lars; Grieger, Frank; Joeres, Lars; Moran, Kimberly; Schollmayer, Erwin; Whitesides, John; Carney, Hannah C.; Walters, Arthur S.; Oertel, Wolfgang; Trenkwalder, Claudia (2016): Rotigotine's effect on PLM-associated blood pressure elevations in restless legs syndrome An RCT. In: Neurology, Vol. 86, No. 19: pp. 1785-1793
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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.