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Separating efficacy and sedative effects of guanfacine extended release in children and adolescents with ADHD from four randomized, controlled, phase 3 clinical trials

Published online by Cambridge University Press:  23 March 2020

M. Huss ,
K. McBurnett ,
A.J. Cutler ,
A. Hervás ,
J. Gu ,
B. Dirks  and
J.H. Newcorn
M. Huss*
Affiliation:
Johannes Gutenberg University Mainz, Child and Adolescent Psychiatry, Mainz, Germany
K. McBurnett
Affiliation:
University of California, Department of Psychiatry, San Francisco, USA
A.J. Cutler
Affiliation:
Florida Clinical Research Center, Child and Adolescent Psychiatry, Bradenton, USA
A. Hervás
Affiliation:
University Hospital Mútua de Terrassa, UEDT, Hospital Sant Joan de Deu, Child and Adolescent Mental Health Unit, Barcelona, Spain
J. Gu
Affiliation:
Shire, Biostatistics, Wayne, USA
B. Dirks
Affiliation:
Shire, Neuroscience, Wayne, USA
J.H. Newcorn
Affiliation:
Icahn School of Medicine at Mount Sinai, Department of Psychiatry, New York, USA
*
*Corresponding author.

Abstract

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Introduction

Guanfacine extended release (GXR) is a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD).

Objective

To separate efficacy and sedative treatment-emergent adverse events (TEAEs) associated with GXR in four randomized, controlled trials in children (6–12 years) and adolescents (13–17 years) with ADHD.

Methods

SPD503-301 (n = 345) and SPD503-304 (n = 324) were 8 and 9 week studies of fixed-dose GXR (≤ 4 mg/day). SPD503-312 (n = 314; adolescents only) and SPD503-316 (n = 338) were 10–13 week studies of dose-optimized GXR (1–7 mg/day).

Results

In fixed-dose studies, pooled incidences of sedative TEAEs with GXR were highest at week 1 (GXR, 13.9–18.7%; placebo, 8.7%) and decreased to placebo levels at week 8 (0–1.4%; placebo, 0%). In contrast, proportions of responders (≥ 30% reduction from baseline in ADHD Rating Scale IV [ADHD-RS-IV] total score) increased from week 1 (GXR, 29.6–34.8%; placebo, 25.0%) through endpoint (GXR, 66.7–72.2%; placebo, 42.6%). Incidences of sedative TEAEs, but not proportions of responders, increased with GXR dosing. GXR was associated with a statistically significant reduction in ADHD-RS-IV total score from baseline to endpoint in patients without sedative TEAEs in both fixed-dose and dose-optimized studies (GXR versus placebo, effect size = 0.49 and 0.67, respectively; P < 0.001). GXR was associated with statistically significant improvements compared with placebo in both ADHD-RS-IV Hyperactivity/Impulsivity and Inattentiveness subscale scores (P < 0.001).

Conclusion

These data from pooled GXR clinical trials indicate that incident sedative TEAEs do not contribute to increased treatment response over time, and that sedation and symptomatic improvement are distinct effects of GXR.

Disclosure of interest

The authors have not supplied their declaration of competing interest.

Type
FC14
Information
European Psychiatry , Volume 33 , Issue S1: Abstracts of the 24th European Congress of Psychiatry , March 2016 , pp. S76 - S77
Copyright
Copyright © European Psychiatric Association 2016
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