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EPA-0993 – Health Utility Scores in Children and Adolescents with Attention-deficit/Hyperactivity Disorder: Response to Stimulant Treatment

Published online by Cambridge University Press:  15 April 2020

P. Hodgkins
Affiliation:
Global Health Economics and Outcomes Research, Shire Development LLC, Wayne, USA
J. Setyawan
Affiliation:
Global Health Economics and Outcomes Research, Shire Development LLC, Wayne, USA
T. Banaschewski
Affiliation:
Department of Child and Adolescent Psychiatry and Psychotherapy, University of Heidelberg, Mannheim, Germany
C. Soutullo
Affiliation:
Department of Psychiatry and Medical Psychology, University of Navarra, Pamplona, Spain
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
M. Johnson
Affiliation:
Child Neuropsychiatry Unit, Queen Silvia Children's Hospital, Gothenburg, Sweden
A. Zuddas
Affiliation:
Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy
B. Adeyi
Affiliation:
Global Biostatistics, Shire Development LLC, Wayne, USA
L.A. Squires
Affiliation:
Global Clinical Development and Innovation, Shire Development LLC, Wayne, USA
D.R. Coghill
Affiliation:
Division of Neuroscience, University of Dundee, Dundee, United Kingdom

Abstract

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Introduction:

The Health Utilities Index-Mark 2 (HUI2), a generic instrument for assessing health status, is an important effectiveness input for pharmacoeconomic modelling. It has not previously been used in patients with attention deficit/hyperactivity disorder (ADHD).

Objective:

To use HUI2 to assess health utility in patients aged 6–17 years with ADHD receiving the prodrug stimulant lisdexamfetamine dimesylate (LDX).

Methods:

SPD489-325 was a 7-week, randomized, double-blind, placebo-controlled trial of LDX, with osmotic-release oral system methylphenidate (OROSMPH) as a reference treatment. Patients’ parents or guardians completed HUI2 questionnaires at baseline and weeks 4 and 7. Utilities were estimated for treatment responders and non-responders, with response defined as a Clinical Global Impressions-Improvement (CGI-I) score of 1 or 2, or a ≥25% or ≥30% reduction in ADHD Rating Scale IV (ADHD-RS-IV) total score.

Results:

Of 336 patients randomized, 317 were included in the full analysis set (LDX, n=104; OROS-MPH, n=107; placebo, n=106) and 196 completed the study. At endpoint, mean HUI2 utility scores across all treatment groups were higher for responders than non-responders when response was based on CGI-I score (responders: 0.896 [SD, 0.0990]; non-responders: 0.838 [0.1421]), on a ≥25% reduction in ADHD-RS-IV score from baseline (responders, 0.899 [0.0969]; non-responders, 0.809 [0.1474]), or on a ≥30% reduction in ADHD-RS-IV score from baseline (responders, 0.902 [0.0938]; non-responders 0.814 [0.1477]).

Conclusions:

The HUI2 instrument is sensitive to treatment response in the child and adolescent ADHD patient population. Health utilities generated using HUI2 are therefore suitable for cost effectiveness evaluations of ADHD medications.

Supported by funding from Shire

Type
S537 - Effectiveness of stimulant treatment in attention-deficit/hyperactivity disorder: functional, health-related quality of life and health utility outcome measures
Copyright
Copyright © European Psychiatric Association 2014
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