Limits...
Rotigotine's effect on PLM-associated blood pressure elevations in restless legs syndrome: An RCT.

Bauer A, Cassel W, Benes H, Kesper K, Rye D, Sica D, Winkelman JW, Bauer L, Grieger F, Joeres L, Moran K, Schollmayer E, Whitesides J, Carney HC, Walters AS, Oertel W, Trenkwalder C, SP0977 study investigato - Neurology (2016)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: From 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.

No MeSH data available.


Related in: MedlinePlus

Study flow chartAEs = adverse events; FAS = full analysis set; SS = safety set. *One patient did not receive study medication. **Patient discontinued after completing the maintenance period.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4862252&req=5

Figure 1: Study flow chartAEs = adverse events; FAS = full analysis set; SS = safety set. *One patient did not receive study medication. **Patient discontinued after completing the maintenance period.

Mentions: Of 81 randomized patients, 80 received study medication and 67 completed the 4-week maintenance period (figure 1). In total, 66 patients were included in the FAS (figure 1; table 1); one patient on placebo was excluded due to a nonreadable baseline polysomnographic recording. Patients had a high PLMI at baseline (table 2) and severe RLS as indicated by mean IRLS scores (26.6 ± 4.6; 27.1 ± 5.1) (table e-1). Of 15 patients who discontinued prematurely, one did not receive study medication, 10 withdrew during titration, 3 withdrew during maintenance, and 1 withdrew after completion of the maintenance period. AEs were the most common reason for premature discontinuation among rotigotine-treated patients, whereas the majority of discontinuations from placebo occurred due to lack of efficacy (figure 1). Mean exposure to study medication was 51.8 ± 8.6 days for rotigotine (median 54 days) and 47.1 ± 17.7 days for placebo (median 55.5 days). During maintenance, 50% (19/38) of rotigotine-treated patients received 3 mg/24 h, and 37% (14/38) received 2 mg/24 h.


Rotigotine's effect on PLM-associated blood pressure elevations in restless legs syndrome: An RCT.

Bauer A, Cassel W, Benes H, Kesper K, Rye D, Sica D, Winkelman JW, Bauer L, Grieger F, Joeres L, Moran K, Schollmayer E, Whitesides J, Carney HC, Walters AS, Oertel W, Trenkwalder C, SP0977 study investigato - Neurology (2016)

Study flow chartAEs = adverse events; FAS = full analysis set; SS = safety set. *One patient did not receive study medication. **Patient discontinued after completing the maintenance period.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4862252&req=5

Figure 1: Study flow chartAEs = adverse events; FAS = full analysis set; SS = safety set. *One patient did not receive study medication. **Patient discontinued after completing the maintenance period.
Mentions: Of 81 randomized patients, 80 received study medication and 67 completed the 4-week maintenance period (figure 1). In total, 66 patients were included in the FAS (figure 1; table 1); one patient on placebo was excluded due to a nonreadable baseline polysomnographic recording. Patients had a high PLMI at baseline (table 2) and severe RLS as indicated by mean IRLS scores (26.6 ± 4.6; 27.1 ± 5.1) (table e-1). Of 15 patients who discontinued prematurely, one did not receive study medication, 10 withdrew during titration, 3 withdrew during maintenance, and 1 withdrew after completion of the maintenance period. AEs were the most common reason for premature discontinuation among rotigotine-treated patients, whereas the majority of discontinuations from placebo occurred due to lack of efficacy (figure 1). Mean exposure to study medication was 51.8 ± 8.6 days for rotigotine (median 54 days) and 47.1 ± 17.7 days for placebo (median 55.5 days). During maintenance, 50% (19/38) of rotigotine-treated patients received 3 mg/24 h, and 37% (14/38) received 2 mg/24 h.

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: From 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.

No MeSH data available.


Related in: MedlinePlus