Nervenheilkunde 2011; 30(07): 504-508
DOI: 10.1055/s-0038-1628387
Forum Neuropharmakotherapie
Schattauer GmbH

Behandlung des mittelschweren bis schweren Restless-legs-Syndroms

Klinische Daten zu Rotigotin transdermalem SystemRotigotine transdermal system in the treatment of moderate to severe restless legs syndromeA review of clinical data
O. Randerath
1   Arzt, Leverkusen, Ambulantes Schlaflabor, Marburg
,
H. Benes
2   Somni bene, Institut für medizinische Forschung und Schlafmedizin, Schwerin
,
I. Eisensehr
3   Ärztin für Neurologie und Schlafmedizin, München
,
K. Stiasny-Kolster
4   Somnomar, Institut für medizinische Forschung und Schlafmedizin, Ambulantes Schlaflabor, Marburg
› Author Affiliations
Further Information

Publication History

Eingegangen am: 03 January 2011

angenommen am: 28 February 2011

Publication Date:
23 January 2018 (online)

Zusammenfassung

Rotigotin transdermales System wurde als erstes Wirkstoffpflaster zur kontinuierlichen Behandlung des mittelschweren bis schweren idiopathischen Restless-legs-Syndroms (RLS) bei Erwachsenen zugelassen. Es enthält den nicht ergolinen Dopaminagonisten Rotigotin, der kontinuierlich über 24 Stunden in die Blutbahn abgegeben wird. Dies ermöglicht eine Beherrschung der klinischen Symptome über den Tag und könnte durch die kontinuierliche dopaminerge Stimulation über die Pflasterapplikation im Vergleich zu bisher verfügbaren Therapien mit einer geringeren Augmentationsrate verbunden sein. Ziel dieser Übersichtsarbeit ist es, die publizierten Studiendaten vorzustellen und mögliche Vorteile der neuen Therapieoption für die klinische Praxis herauszuarbeiten.

Summary

Rotigotine transdermal system is the first transdermal system that was launched fort the treatment of moderate to severe idiopathic restless legs syndrome (RLS) in adults. The patch releases continuously the non-ergoline dopamine agonist rotigotine over a period of 24 hours. The continuous dopaminergic stimulation leads to a control of daytime symptoms and could result in a lower augmentation rate in comparison to orally delivered drug. Purpose of this review was to summarize results of the clinical trials and to point out potential benefits of transdermal treatment in RLS for daily routine.

 
  • Literatur

  • 1 Allen RP. et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005; 165: 1286-92.
  • 2 Baldwin CM, Keating GM. Rotigotine transdermal patch in restless legs syndrome. CNS Drugs 2008; 797-806.
  • 3 Benes H. et al. Augmentation in long-term therapy of the restless legs syndrome with transdermal rotigotine – a retrospective systematic analysis of two large open-label 1-year trials. Abstract MDS 13th International Congress, Paris: 2009
  • 4 Braun M, Cawello W, Poole K. Steady-state pharmacokinetics of rotigotine in patients with earlystage Parkinson’s disease (abstract no. PI 245). 10th Congress of the European Federation of Neurological Societies, Glasgow: 2006
  • 5 Braun M, Cawello W, Horstmann R. Lack of pharmacokinetic interaction between the dopamine agonist rotigotine and levodopa (abstract no 102). 16th International Congress on Parkinson’s Disease and related Disorders, Berlin: 2005
  • 6 Braun M, Elshoff JP, Andreas JO. Lack of drug interactions between transdermal rotigotine and oral contraceptives (abstract no. 879). Mov Disord 2007; 22 (Suppl. 16) 269.
  • 7 Garcia-Borreguero D. et al. Long-term safety and efficacy of rotigotine in idiopathic RLS: 3-year results from a multinational open-label trial. 19th Congress of the European Sleep Research Society, Glasgow: 2008
  • 8 Hansen K, Braun M, Horstmann R. Low drug-drug interaction potential of rotigotine. J Clin Pharmacol 2005; 45 (09) 1091.
  • 9 Hening W. et al. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004; 05: 237-46.
  • 10 Högl B. et al. Long-term safety and efficacy of rotigotine in patients with idiopathic RLS: 5-year results from a prospective multinational open-label follow-up study. 62nd American Academy of Neurology annual meeting, Toronto: 2010
  • 11 Oertel W. et al. Efficacy of rotigotine transdermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Medicine 2008; 09 (03) 228-39.
  • 12 Oertel WH. et al. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med 2008; 09: 865-73.
  • 13 Mathis J, Grandjean P. Das Restless-Legs-Syndrom in der Praxis. Schweiz Med Forum 2009; 04: 67-71.
  • 14 Paulus W, Trenkwalder C. Update zur Pathophysiologie. Akt Neurol 2007; 34 (Suppl. 01) S2-S5.
  • 15 RLS e. V. Deutsche Restless Legs Vereinigung. Restless Legs Syndrom. In: Restless Legs Syndrom, RLS e. V. (Hrsg.). 2. Auflage. Marburg: KVM Dr. Kolster Produktions und Verlags GmbH; 2005
  • 16 Stiasny-Kolster K. et al. Untersuchung von Rotigotin transdermalem System zur Behandlung der motorischen Symptome des mittelschweren bis schweren idiopathischen restless Legs Syndrom (RLS): Ergebnisse einer 7-wöchigen Schlaflabor-Studie. Somnologie 2008; (Suppl. 01) 50.
  • 17 Stiasny-Kolster K. et al. Patch application of the dopamine agonist rotigotine to patients witch moderate to advanced stages of restless legs syndrome: a double-blind, placebo-controlled pilot study. Movement Disorders 2004; 19 (12) 1422-37.
  • 18 Trenkwalder C. et al. Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurology 2008; 07 (07) 595-604.
  • 19 Trenkwalder C. Leitliniengruppe der Deutschen Gesellschaft für Neurologie (DGN). Leitlinie zur Diagnose und Therapie des Restless-Legs-Syndroms (RLS). Stuttgart: Thieme Verlag; 2007
  • 20 Fachimformation Neupro® 1 mg und 3 mg, 2009