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Time-course of treatment-emergent adverse events in a long-term safety study of lisdexamfetamine dimesylate in children and adolescents with ADHD

Published online by Cambridge University Press:  23 March 2020

I. Hernández Otero ,
T. Banaschewski ,
P. Nagy ,
C.A. Soutullo ,
A. Zuddas ,
B. Caballero ,
B. Geibel ,
B. Yan  and
D.R. Coghill
I. Hernández Otero*
Affiliation:
University Hospital Virgen de la Victoria–Maritime Hospital, Unit of Child and Adolescent Mental Health USMIJ, Torremolinos, Spain
T. Banaschewski
Affiliation:
Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Department of Child and Adolescent Psychiatry and Psychotherapy, Mannheim, Germany
P. Nagy
Affiliation:
Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic, Child and Adolescent Psychiatry, Budapest, Hungary
C.A. Soutullo
Affiliation:
University of Navarra Clinic, Child and Adolescent Psychiatry Unit, Department of Psychiatry and Medical Psychology, Pamplona, Spain
A. Zuddas
Affiliation:
University of Cagliari, Department of Biomedical Sciences, Section of Neuroscience and Clinical Pharmacology, Cagliari, Italy
B. Caballero
Affiliation:
Shire, Neuroscience, Zug, Switzerland
B. Geibel
Affiliation:
Shire, Neuroscience, Wayne, USA
B. Yan
Affiliation:
Shire, Biostatistics, Wayne, USA
D.R. Coghill
Affiliation:
University of Dundee, Division of Neuroscience, Dundee, United Kingdom
*
* Corresponding author.

Abstract

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Introduction

The long-term safety and efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with attention deficit/hyperactivity disorder (ADHD) was evaluated in a European 2-year, open-label study (SPD489-404).

Objective

To evaluate the time-course of treatment-emergent adverse events (TEAEs) in SPD489-404.

Methods

Participants aged 6–17 years received open-label LDX (30, 50 or 70 mg/day) for 104 weeks (4 weeks dose-optimization; 100 weeks dose-maintenance).

Results

All enrolled participants (n = 314) were included in the safety population and 191 (60.8%) completed the study. TEAEs occurred in 282 (89.8%) participants; most were mild or moderate. TEAEs considered by the investigators as related to LDX were reported by 232 (73.9%) participants with the following reported for ≥ 10% of participants: decreased appetite (49.4%), weight decreased (18.2%), insomnia (13.1%). TEAEs leading to discontinuation and serious TEAEs occurred in 39 (12.4%) and 28 (8.9%) participants, respectively. The median (range) time to first onset and duration, respectively, of TEAEs identified by the sponsor as being of special interest were: insomnia (insomnia, initial insomnia, middle insomnia, terminal insomnia), 17.0 (1–729) and 42.8 (1–739) days; weight decreased, 29.0 (1–677) and 225.0 (26–724) days; decreased appetite, 13.5 (1–653) and 169.0 (1–749) days; headache, 22.0 (1–718) and 2.0 (1–729) days. Reports of insomnia, weight decreased, decreased appetite and headache were highest in the first 4–12 weeks.

Conclusions

TEAEs associated with long-term LDX treatment were characteristic of stimulant medications, with the greatest incidence observed during the first 4–12 weeks.

Disclosure of interest

The authors have not supplied their declaration of competing interest.

Type
EW80
Information
European Psychiatry , Volume 33 , Issue S1: Abstracts of the 24th European Congress of Psychiatry , March 2016 , pp. S132
Copyright
Copyright © European Psychiatric Association 2016
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