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EPA-0719 – Post Hoc Analyses on the Efficacy of Lisdexamfetamine Dimesylate Following Previous Treatment with Attention Deficit/Hyperactivity Disorder Medication

Published online by Cambridge University Press:  15 April 2020

T. Banaschewski ,
M. Lecendreux ,
C. Soutullo ,
A. Zuddas ,
S. Sorooshian ,
B. Adeyi ,
L.A. Squires ,
R. Civil  and
D.R. Coghill
T. Banaschewski
Affiliation:
Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Mannheim, Germany
M. Lecendreux
Affiliation:
Paediatric Sleep Centre and National Reference Centre for Orphan Diseases: Narcolepsy Idiopathic Hypersomnia and Kleine-Levin Syndrome, Robert-Debré University Hospital, Paris, France
C. Soutullo
Affiliation:
Department of Psychiatry and Medical Psychology, University of Navarra, Pamplona, Spain
A. Zuddas
Affiliation:
Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy
S. Sorooshian
Affiliation:
Clinical Development and Medical Affairs, Shire AG, Eysins, Switzerland
B. Adeyi
Affiliation:
Global Biostatistics, Shire Development LLC, Wayne, USA
L.A. Squires
Affiliation:
Global Clinical Development and Innovation, Shire Development LLC, Wayne, USA
R. Civil
Affiliation:
Clinical Development and Medical Affairs, Shire Development LLC, Wayne, USA
D.R. Coghill
Affiliation:
Division of Neuroscience, University of Dundee, Dundee, United Kingdom

Abstract

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Background:

The prodrug lisdexamfetamine dimesylate (LDX) is licensed in several European countries for treating attention-deficit/hyperactivity disorder (ADHD) in children and adolescents with an inadequate response to methylphenidate (MPH) treatment.

Objectives/Aims:

To evaluate post hoc the impact of ADHD medication history on the efficacy of LDX.

Methods:

In this 7-week, dose-optimized, double-blind, study, patients (6–17 years) were randomized 1:1:1 to LDX, placebo or osmotic-release oral system methylphenidate (OROS-MPH). Efficacy assessments included ADHD Rating Scale IV (ADHD-RS-IV) and Clinical Global Impressions-Improvement (CGI-I) scores.

Results:

The full analysis set (FAS) comprised 317 patients. Baseline characteristics were similar across treatment groups and previous treatment subgroups. At endpoint, the mean change from baseline in ADHD-RS-IV total score and proportions of responders based on a CGI-I of 1 or 2 for LDX, OROS-MPH and placebo are presented below.

Previous treatment sub-groupLDXPlaceboOROS-MPH
Mean change (SD) in ADHD-RS-IV total score
FAS (N=317)−24.7 (10.15)−6.3 (10.02)−18.9 (12.92)
Treatment-naïve (n=147)−24.0 (10.00)−8.5 (10.34)−21.4 (13.09)
Any previous ADHD medication (n=170)−25.3 (10.34)−4.2 (9.30)−16.9 (12.53)
Previous MPH treatment (n=146)−25.4 (10.67)−4.7 (9.70)−17.7 (11.96)
Proportion of responders (95% CI): CGI-I 1 or 2
FAS (N=317)78.0% (69.9, 86.1)14.4% (7.7, 21.2)60.6% (51.2, 70.0)
Treatment-naïve (n=147)80.4% (69.0, 91.9)19.6% (8.7, 30.5)63.8% (50.1, 77.6)
Any previous ADHD medication (n=170)75.9% (64.5, 87.3)9.4% (1.6, 17.3)57.9% (45.1, 70.7)

Conclusions:

LDX and OROS-MPH were associated with clinically relevant improvements in ADHD symptoms irrespective of ADHD medication history.

Study funded by Shire

Type
E06 - e-Poster Oral Session 06: Child Psychiatry and Personality Disorders
Information
European Psychiatry , Volume 29 , Issue S1: Abstracts of the 22nd European Congress of Psychiatry , 2014 , pp. 1
Copyright
Copyright © European Psychiatric Association 2014
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