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Fortschr Neurol Psychiatr 2015; 83(12): 676-685
DOI: 10.1055/s-0041-110441
Übersicht
© Georg Thieme Verlag KG Stuttgart · New York

Lisdexamfetamindimesilat: Eine Behandlungsoption für Kinder und Jugendliche mit Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung in Deutschland und Europa

Lisdexamfetamine dimesylate: a Treatment Option for Children and Adolescents with Attention Deficit/Hyperactivity Disorder in Germany and Across Europe
A. Häge
,
T. Banaschewski
,
R. W. Dittmann
Further Information

Publication History

Publication Date:
29 December 2015 (online)

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Zusammenfassung

Die Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung (ADHS) ist eine neuropsychiatrische Entwicklungsstörung, die bis in das Jugend- und Erwachsenenalter fortbestehen kann. In Deutschland werden Psychostimulanzien und Atomoxetin (ATX) häufig zur Behandlung von ADHS verschrieben. Lisdexamfetamindimesilat (LDX) ist das neueste in Deutschland und in weiteren europäischen Ländern zur Behandlung von ADHS zugelassene Medikament. Im Rahmen dieser Übersichtsarbeit werden die Ergebnisse von drei zulassungsrelevanten Studien der Phase 3/3b zur medikamentösen Behandlung von Kindern und Jugendlichen mit ADHS mit dem Wirkstoff LDX zusammenfassend dargestellt. Diese umfassen Daten zur klinischen Wirksamkeit (Studie SPD489 – 325), zur Aufrechterhaltung der Wirksamkeit (Studie SPD489 – 326) sowie zur Wirksamkeit im direkten Vergleich zu ATX bei Patienten, die zuvor unzureichend auf eine Behandlung mit Methylphenidat (MPH) angesprochen hatten (Studie SPD489 – 317). Die Behandlung mit LDX war in einer Reihe von Wirksamkeitsparametern mit statistisch signifikanten Vorteilen gegenüber Placebo bzw. ATX verbunden. In allen drei europäischen Studien zeigte sich ein Nebenwirkungs- und Verträglichkeitsprofil für LDX, das mit dem anderer Psychostimulanzien, die zur Behandlung von Patienten mit ADHS verwendet werden, übereinstimmt.

Abstract

Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder – which may persist into adolescence and adulthood. Psychostimulants and atomoxetine (ATX) are frequently prescribed to treat ADHD in Germany. Lisdexamfetamine dimesylate (LDX) is the most recently approved ADHD medication in Germany and other European countries. Data used to support the European registration of LDX is summarised from three phase-3/3b studies in children and adolescents with ADHD. Short-term efficacy (study SPD489 – 325), maintenance of efficacy (study SPD489 – 326) and efficacy in patients who had previously responded inadequately to methylphenidate (MPH) treatment (study SPD489 – 317) were demonstrated. The safety and tolerability profile of LDX in all three European studies was shown to be in line with that of other psychostimulants used to treat patients with ADHD.

Schlüsselwörter

Aufmerksamkeitsdefizit-/Hyperaktivitätsstörung - Lisdexamfetamindimesilat - Deutschland - klinische Studien

Key words

lisdexamfetamine dimesylate - Germany - clinical studies - attention deficit hyperactivity disorder
 

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