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Aktuelle Neurologie 2004; 31(7): 347-352
DOI: 10.1055/s-2004-828369
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Eine neue galenische Zubereitung von Selegin (Xilopar®) in der Behandlung des Morbus Parkinson

A New Galenic Formulation of Selegiline (Xilopar®) in the Treatment of Parkinson DiseaseT.  Müller1 , J.  Glaß2 , D.  Müller3 , A.  Link4 , C.  Schenk5 , G.  Rammes6
  • 1Neurologische Klinik der Ruhr-Universität Bochum
  • 2Praxis für Neurologie und Psychiatrie, Neubrandenburg
  • 3Praxis für Neurologie und Psychiatrie, Ilmenau
  • 4Praxis für Neurologie, Psychiatrie und Psychotherapie, Celle
  • 5Praxis für Neurologie und Psychiatrie, Osnabrück
  • 6Max Planck Institut für Psychiatrie, München
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Publication History

Publication Date:
27 August 2004 (online)

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Zusammenfassung

Selegilin ist ein selektiver irreversibler Hemmer der Monoaminoxidase-B. Die Wirksamkeit, Verträglichkeit und Sicherheit wurde in umfangreichen kontrollierten Studien an Patienten mit idiopathischem Morbus Parkinson nachgewiesen. Selegilin wird bevorzugt im Frühstadium des M. Parkinson als Monotherapie eingesetzt, so kann auch die Gabe von Levodopa hinausgezögert werden. Selegilin ist jetzt auch als eine Schmelztablette (Xilopar®) erhältlich, die über die Mundschleimhaut überwiegend resorbiert wird und den First-pass-Effekt der Leber umgeht. So wird eine deutliche Reduktion der Amphetaminderivate und gleichzeitig bei oraler Einnahme von nur 1/8 der üblichen Dosis eines konventionellen Präparates ein ähnliches pharmakokinetisches Verhalten der Wirksubstanz Selegilin im Blut erreicht. Ziel dieser multizentrischen Anwendungsbeobachtung war die Bestätigung der Ergebnisse aus Studien mit Xilopar® unter kontrollierten Studienbedingungen jetzt in der täglichen Praxisrealität mit Dokumentation der Behandlungsdaten. Patienten mit idiopathischem Morbus Parkinson, welche erstmals mit Xilopar® behandelt wurden, als auch Patienten, die von konventionellem Selegilin auf Xilopar® umgestellt wurden, zeigten nach 3 Monaten eine Verbesserung der motorischen Symptome und der Fluktuationen der Beweglichkeit. Auch konnte in beiden Patientengruppen eine Reduktion der oralen Levodopadosis pro Tag erzielt werden (Erstbehandlung mit Xilopar®: 21 %; 143 ± 115 [Mittelwert ± SD] mg/Tag; Umstellung auf Xilopar®: 17 %; 98 ± 40 mg/Tag). Relevante Nebenwirkungen traten nicht auf. Diese Ergebnisse bestätigen die Effizienz von Xilopar® in der Behandlung des Morbus Parkinson.

Abstract

Selegiline is a selective and irreversible inhibitor of monoamine oxidase B (MAO-B). Selegiline is looked upon as a putative progression of Parkinson's disease (PD) delaying compound due to its in preclinical research proven neuroprotective modes of action. Xilopar® is a new formulation of selegiline, which facilitates absorption in the mouth and thus avoids hepatic first-pass metabolism. Intake of 1.25 mg Xilopar® provides similar pharmacokinetic plasma behaviour corresponding to oral administration of 10 mg conventional selegiline. This observational trial evaluated the efficacy, safety and tolerability of Xilopar® in the daily practice. Motor symptoms and fluctuations of PD patients improved after 3 months of initial treatment with Xilopar® or switch from selegiline to Xilopar®. Both treatment strategies enabled a reduction of the daily oral levodopa intake (initial treatment with Xilopar®: 21 %; 143 ± 115 [mean ± SD] mg/daily; pre-treatment with selegiline: 17 %; 98 ± 40 mg/daily). There were no safety or tolerability problems. The results of this observational trial confirm the clinical efficacy, tolerability and safety of Xilopar®, respectively conventional selegiline formulations in the treatment of PD.

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Prof. Dr. Thomas Müller

Neurologische Universitätsklinik im St.-Josef-Hospital · Ruhr-Universität Bochum

Gudrunstraße 56

44791 Bochum

Email: thomas.mueller@ruhr-uni-bochum.de