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Rotigotine's effect on PLM-associated blood pressure elevations in restless legs syndrome: An RCT
Axel Bauer1, Werner Cassel2, Heike Benes2
1From the Munich University Clinic and DZHK (German Centre for Cardiovascular Research) (A.B.); Philipps Universität Marburg (W.C., K.K., W.O.); Somni Bene Institut für Medizinische Forschung und Schlafmedizin (H.B.), Schwerin; Medical Center (H.B.), Rostock University, Germany; Emory University (D.R.), Atlanta, GA; Virginia Commonwealth University (D.S.), Richmond; Massachusetts General Hospital (J.W.W.), Boston; UCB Pharma (L.B., F.G., L.J., E.S.), Monheim am Rhein, Germany; UCB Pharma (K.M.), Smyrna, GA; UCB Pharma (J.W.), Raleigh, NC; Evidence Scientific Solutions (H.C.C.), Horsham, UK; Vanderbilt University School of Medicine (A.S.W.), Nashville, TN; Hertie Foundation (W.O.), Frankfurt am Main; and Department of Neurosurgery (C.T.), University Medical Center, Göttingen and Paracelsus-Elena-Klinik, Kassel, Germany. axel.bauer@med.uni-muenchen.de.
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.
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