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P-339 - Effect of Lisdexamfetamine Dimesylate on Functional Impairment in Children and Adolescents With Attention-deficit/hyperactivity Disorder

Published online by Cambridge University Press:  15 April 2020

C.A. Soutullo
Affiliation:
Child and Adolescent Psychiatry Unit, Department of Psychiatry & Medical Psychology, University Clinic of Navarra, Pamplona, Spain
T. Banaschewski
Affiliation:
Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
M.L. Lecendreux
Affiliation:
Pediatric Sleep Center, CHU Hospital Robert-Debré, Paris, France
R. Bloomfield
Affiliation:
Shire Pharmaceutical Development Ltd., Basingstoke, UK
P. Hodgkins
Affiliation:
Shire Development Inc., Wayne, PA, USA
D.R. Coghill
Affiliation:
Division of Neuroscience, Ninewells Hospital, Dundee, UK

Abstract

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Introduction:

Lisdexamfetamine dimesylate (LDX) is the first long-acting, prodrug stimulant, and is approved in the USA, Canada and Brazil for the treatment of attention-deficit/hyperactivity disorder (ADHD).

Objectives and aims:

To evaluate the effect of LDX on functional impairment in patients with ADHD, using the Weiss Functional Impairment Rating Scale-Parent (WFIRS-P).

Methods:

A randomized, double-blind, placebo-controlled trial of an optimized daily dose of LDX was conducted in children and adolescents (6–17 years) with ADHD in Europe. A 4-week dose-optimization period was followed by 3-weeks of dose-maintenance. the WFIRS-P was completed at baseline, day 28 and endpoint. A decrease from baseline indicated an improvement in functional outcomes. Osmotic-release oral system methylphenidate (OROS-MPH) was included as a reference treatment arm.

Results:

of 336 randomized patients, 317 were included in the full analysis set and 196 completed the study. Baseline mean (SD) WFIRS-P total scores were similar across treatment groups: LDX, 1.01 (0.45); placebo, 1.10 (0.46); OROS-MPH, 1.07 (0.44). the least squares (LS) mean decrease (95% confidence intervals) in WFIRS-P total score from baseline to endpoint was statistically significantly greater with LDX than with placebo (difference of −0.3 [−0.4, −0.2], p < 0.001), with an effect size of 0.924 for LDX. the difference in LS mean change from baseline to endpoint between OROS-MPH and placebo was −0.2 (−0.3, −0.1; p < 0.001) in favour of OROS-MPH (effect size, 0.772).

Conclusions:

LDX was more effective than placebo in improving functional impairments in children and adolescents with ADHD.

Supported:

By funding from Shire Development Inc.

Type
Abstract
Copyright
Copyright © European Psychiatric Association 2012
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