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Eur Neuropsychopharmacol. 2014 Dec;24(12):1861-72. doi: 10.1016/j.euroneuro.2014.09.014. Epub 2014 Oct 23.

Efficacy and safety of extended-release guanfacine hydrochloride in children and adolescents with attention-deficit/hyperactivity disorder: a randomized, controlled, phase III trial.

Author information

1
Child and Adolescent Mental Health Unit, University Hospital Mútua de Terrassa, UETD, Hospital Sant Joan de Deu, Barcelona, Spain. Electronic address: 32989ahz@comb.cat.
2
Child and Adolescent Psychiatry, Johannes Gutenberg-University Mainz, Mainz, Germany.
3
The Gillberg Neuropsychiatry Centre at the Sahlgrenska Academy, University of Gothenburg, Sweden.
4
Department of Child and Adolescent Psychiatry, Our Lady׳s Children׳s Hospital, Dublin, Ireland.
5
Center for Pediatric Excellence, Ottawa, ON, Canada.
6
Shire, Eysins, Switzerland.
7
Shire, Basingstoke, UK.
8
Shire, Wayne, PA, USA.

Abstract

Guanfacine extended-release (GXR), a selective α2A-adrenergic agonist, is a non-stimulant treatment for attention-deficit/hyperactivity disorder (ADHD). This study assessed the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD. An atomoxetine (ATX) arm was included to provide reference data against placebo. Patients (6-17 years) were randomized at baseline to dose-optimized GXR (0.05-0.12mg/kg/day - 6-12 years: 1-4mg/day; 13-17 years: 1-7mg/day), ATX (10-100mg/day) or placebo for 4 or 7 weeks. The primary efficacy measure was change from baseline in ADHD Rating Scale version IV (ADHD-RS-IV). Key secondary measures were Clinical Global Impression-Improvement (CGI-I) and the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P; learning and school, and family domains). Safety assessments included treatment-emergent adverse events (TEAEs), electrocardiograms and vital signs. A total of 272 (80.5%) patients from Europe, the USA and Canada completed the study. Significant differences were observed in least squares mean change from baseline in ADHD-RS-IV total score (placebo-adjusted differences) (GXR: [-8.9, p<0.001]; ATX: [-3.8, p<0.05]), the difference from placebo in the percentage of patients showing improvement (1 ['very much improved'] or 2 ['much improved']) for CGI-I (GXR: [23.7, p<0.001]; ATX: [12.1, p<0.05]), WFIRS-P learning and school domain (GXR: [-0.22, p<0.01]; ATX: [-0.16, p<0.05]) and WFIRS-P family domain (GXR: [-0.21, p<0.01]; ATX: [-0.09, p=0.242]). Most common TEAEs for GXR were somnolence, headache and fatigue; 70.1% of GXR subjects reported mild-to-moderate TEAEs. GXR was effective and well tolerated in children and adolescents with ADHD.

KEYWORDS:

Attention-deficit/hyperactivity disorder; Function; Guanfacine; Safety; Treatment efficacy

PMID:
25453486
DOI:
10.1016/j.euroneuro.2014.09.014
[Indexed for MEDLINE]
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