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957 – Post Hoc Comparison Of The Efficacy Of Lisdexamfetamine Dimesylate And Osmotic-release Oral System Methlyphenidate In Children And Adolescents With Adhd

Published online by Cambridge University Press:  15 April 2020

D. Coghill ,
T. Banaschewski ,
M. Lecendreux ,
C. Soutullo ,
M. Johnson ,
A. Zuddas ,
C. Anderson ,
R. Civil ,
N. Higgins  and
R. Bloomfield
...Show all authors
D. Coghill
Affiliation:
Division of Neuroscience, Ninewells Hospital, Dundee, UK
T. Banaschewski
Affiliation:
Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
M. Lecendreux
Affiliation:
Pediatric Sleep Center, CHU Robert Debré, Paris, France
C. Soutullo
Affiliation:
Child and Adolescent Psychiatry Unit, Department of Psychiatry and Medical Psychology, University Clinic of Navarra, Pamplona, Spain
M. Johnson
Affiliation:
Child Neuropsychiatry Unit, Queen Silvia Children's Hospital, Gothenburg, Sweden
A. Zuddas
Affiliation:
Department of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, University of Cagliari, Cagliari, Italy
C. Anderson
Affiliation:
Shire Development LLC, Wayne, PA, USA
R. Civil
Affiliation:
Shire Development LLC, Wayne, PA, USA
N. Higgins
Affiliation:
Shire Development LLC, Wayne, PA, USA
R. Bloomfield
Affiliation:
Shire Pharmaceutical Development Ltd, Basingstoke, UK
L. Squires
Affiliation:
Shire Development LLC, Wayne, PA, USA

Abstract

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Introduction

In a European, phase 3 study (SPD489-325), lisdexamfetamine dimesylate (LDX) and osmotic-release oral system methylphenidate (OROS-MPH) were more effective than placebo in improving core symptoms in children and adolescents with attention-deficit/hyperactivity disorder (ADHD).

Objectives and aims

To compare post hoc the efficacy of LDX and OROS-MPH in study SPD489-325.

Methods

This 7-week, randomized, double-blind, parallel-group, dose-optimized, placebo-controlled trial enrolled patients aged 6-17 years with ADHD of at least moderate severity. Patients were randomized (1:1:1) to receive a once-daily dose of LDX (30, 50, 70 mg/day), OROS-MPH (18, 36, 54 mg/day) or placebo. Efficacy was assessed using the ADHD Rating Scale version IV (ADHD-RS-IV) and the Clinical Global Impression-Improvement (CGI-I) scale. Endpoint was defined as the last ontherapy treatment visit with a valid assessment.

Results

The full analysis set comprised 317 patients (LDX, n=104; placebo, n=106; OROS-MPH, n=107). The difference between LDX and OROS-MPH in least squares mean change (95% confidence interval [CI]) in ADHD-RS-IV total score from baseline to endpoint was statistically significant in favour of LDX (-5.6 [-8.4, -2.7]; p < 0.001; effect size, 0.541). The difference (LDX minus OROS-MPH) in the percentage of patients (95% CI) with an improved CGI-I score at endpoint was also statistically significant in favour of LDX (17.4 [5.0, 29.8]; p < 0.05).

Conclusions

This post hoc analysis indicated that LDX is significantly more effective than OROS-MPH in improving core symptoms and global functioning in children and adolescents with ADHD.

Supported by: Funding from Shire Development LLC.

Type
Abstract
Information
European Psychiatry , Volume 28 , Issue S1: Abstracts of the 21th European Congress of Psychiatry , 2013 , 28-E391
Copyright
Copyright © European Psychiatric Association 2013
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