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Growth and Sexual Maturation in a 2-year, Open-label Clinical Study of Lisdexamfetamine Dimesylate in Children and Adolescents with ADHD

Published online by Cambridge University Press:  23 March 2020

I. Hernández Otero ,
T. Banaschewski ,
M. Johnson ,
P. Nagy ,
C.A. Soutullo ,
A. Zuddas ,
B. Yan  and
D.R. Coghill
I. Hernández Otero*
Affiliation:
Hospital Virgen de la Victoria, Unit of Child and Adolescent Mental Health USMIJ, Malaga, 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
M. Johnson
Affiliation:
Gillberg Neuropsychiatry Centre, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden
P. Nagy
Affiliation:
Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic, Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic, 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 Science, Child and Adolescent Neuropsychiatric Unit, Cagliari, Italy
B. Yan
Affiliation:
Shire, Lexington, MA, USA
D.R. Coghill
Affiliation:
University of Dundee, Division of Neuroscience, Dundee, United Kingdom
*
*Corresponding author.

Abstract

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Introduction

Individuals with attention-deficit/hyperactivity disorder (ADHD) may require long-term medication.

Objectives

To measure growth and sexual maturation of children and adolescents with ADHD receiving lisdexamfetamine dimesylate (LDX) in a 2-year trial (SPD489-404).

Aims

To investigate the impact of long-term LDX treatment on growth and maturation.

Methods

Participants (6–17 years) received dose-optimized, open-label LDX (30–70 mg/day) for 104 weeks. Weight, height and BMI z-scores were derived using the Centers for Disease Control and Prevention norms [1]. Sexual maturation was assessed using the Tanner scale (participant-rated as closest to their stage of development based on standardized drawings).

Results

Of 314 enrolled participants, 191 (60.8%) completed the study. Mean z-scores at baseline and last on-treatment assessment (LOTA) were 0.53 (standard deviation, 0.963) and 0.02 (1.032) for weight, 0.61 (1.124) and 0.37 (1.131) for height, and 0.32 (0.935) and–0.27 (1.052) for BMI. In general, z-scores shifted lower over the first 36 weeks and then stabilized. At LOTA, most participants remained at their baseline Tanner stage or shifted higher, based on development of hair (males, 95.5%; females, 92.1%) or genitalia/breasts (males, 94.7%; females, 98.4%).

Conclusions

Consistent with previous studies of stimulants used to treat ADHD [2], z-scores for weight, height and BMI decreased, mostly in the first year, then stabilized. No clinically concerning trends of LDX treatment on sexual maturation or the onset of puberty were observed.

Disclosure of interest

Study funded by Shire Development LLC.

Dr Isabel Hernández Otero (Alicia Koplowitz Foundation, Eli Lilly, Forest, Janssen-Cilag, Junta de Andalucia, Roche, Shire, Shire Pharmaceuticals Iberica S.L., and Sunovion).

Type
e-Poster walk: Child and adolescent psychiatry–part 2
Information
European Psychiatry , Volume 41 , Issue S1: Abstract of the 25th European Congress of Psychiatry , April 2017 , pp. S130
Copyright
Copyright © European Psychiatric Association 2017

References

Kuczmarski, R.J., et al.Vital Health Stat 112462002 1190Google Scholar
Faraone, S.V., et al.J Am Acad Child Adolesc Psychiatry 2010; 49: 24–32Google Scholar
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