Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment

Michael Huss,1 Vanja Sikirica,2 Amaia Hervas,3,4 Jeffrey H Newcorn,5 Valerie Harpin,6 Brigitte Robertson71Child and Adolescent Psychiatry, Johannes Gutenberg University Mainz, Mainz, Germany; 2Global Health Economics, Outcomes Research and Epidemiology, Shire, Wayne, PA, USA; 3Child and Adolescent M...

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Autores principales:	Huss M, Sikirica V, Hervas A, Newcorn JH, Harpin V, Robertson B
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	ADHD guanfacine atomoxetine methylphenidate child and adolescent inadequate responders effectiveness trial Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/e65a69e988d04e9195362dbd9342ad01
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spelling	oai:doaj.org-article:e65a69e988d04e9195362dbd9342ad012021-12-02T06:32:18ZGuanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment1178-2021https://doaj.org/article/e65a69e988d04e9195362dbd9342ad012016-05-01T00:00:00Zhttps://www.dovepress.com/guanfacine-extended-release-for-children-and-adolescents-with-attentio-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Michael Huss,1 Vanja Sikirica,2 Amaia Hervas,3,4 Jeffrey H Newcorn,5 Valerie Harpin,6 Brigitte Robertson71Child and Adolescent Psychiatry, Johannes Gutenberg University Mainz, Mainz, Germany; 2Global Health Economics, Outcomes Research and Epidemiology, Shire, Wayne, PA, USA; 3Child and Adolescent Mental Health Unit, University Hospital Mútua de Terressa, Barcelona, Spain; 4Developmental Disorders Unit (UETD), Hospital San Juan de Dios, Barcelona, Spain; 5Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 6Ryegate Children’s Centre, Sheffield Children’s NHS Foundation Trust, Sheffield, UK; 7Global Clinical Development, Shire, Wayne, PA, USAAbstract: Guanfacine extended release (GXR) and atomoxetine (ATX) are nonstimulant treatments for attention-deficit/hyperactivity disorder (ADHD). As nonstimulant treatments are often used after stimulants in ADHD, GXR was assessed relative to prior stimulant treatment in a randomized controlled trial (RCT), in which ATX was included as a reference arm, and in the open-label phase of a randomized-withdrawal study (RWS). Participants were 6–17 years old with ADHD Rating Scale version IV (ADHD-RS-IV) scores ≥32 and Clinical Global Impressions – Severity scores ≥4. RCT participants received dose-optimized GXR (1–7 mg/day), ATX (10–100 mg/day), or placebo for 10–13 weeks. RWS participants received dose-optimized GXR (1–7 mg/day) for 13 weeks. Participants’ last stimulant medication prior to enrolment, and reasons for stopping this medication, were collected at baseline. Change from baseline ADHD-RS-IV score and the proportion of responders were assessed by prior stimulant exposure. Of 163 RCT and 296 RWS participants who had previously received stimulant treatment, 142 and 224, respectively, had received methylphenidate (MPH); due to the low number of participants and the heterogeneity of non-MPH treatments, we only report data for prior MPH treatment. The most frequent reasons for stopping MPH were lack of effectiveness or side effects. Placebo-adjusted ADHD-RS-IV changes from baseline were significant in participants receiving GXR (prior MPH, −9.8, P<0.001, effect size [ES] 0.85; stimulant-naïve, −7.6, P<0.001, ES 0.65). In ATX-treated participants, significant placebo-adjusted differences were seen in stimulant-naïve (−5.0, P=0.022, ES 0.43) but not prior MPH-treated (−1.8, P>0.05, ES 0.15) participants. More participants met responder criteria with GXR versus placebo, regardless of prior treatment. GXR response was unaffected by prior stimulant treatment; ATX produced improvement only in stimulant-naïve participants relative to placebo. These findings may be relevant to clinical decision-making regarding sequencing of ADHD treatments. Keywords: ADHD, atomoxetine, GXR, inadequate responders, effectiveness, trialHuss MSikirica VHervas ANewcorn JHHarpin VRobertson BDove Medical PressarticleADHDguanfacineatomoxetinemethylphenidatechild and adolescentinadequate responderseffectivenesstrialNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2016, Iss Issue 1, Pp 1085-1101 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	ADHD guanfacine atomoxetine methylphenidate child and adolescent inadequate responders effectiveness trial Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	ADHD guanfacine atomoxetine methylphenidate child and adolescent inadequate responders effectiveness trial Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Huss M Sikirica V Hervas A Newcorn JH Harpin V Robertson B Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment
description	Michael Huss,1 Vanja Sikirica,2 Amaia Hervas,3,4 Jeffrey H Newcorn,5 Valerie Harpin,6 Brigitte Robertson71Child and Adolescent Psychiatry, Johannes Gutenberg University Mainz, Mainz, Germany; 2Global Health Economics, Outcomes Research and Epidemiology, Shire, Wayne, PA, USA; 3Child and Adolescent Mental Health Unit, University Hospital Mútua de Terressa, Barcelona, Spain; 4Developmental Disorders Unit (UETD), Hospital San Juan de Dios, Barcelona, Spain; 5Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 6Ryegate Children’s Centre, Sheffield Children’s NHS Foundation Trust, Sheffield, UK; 7Global Clinical Development, Shire, Wayne, PA, USAAbstract: Guanfacine extended release (GXR) and atomoxetine (ATX) are nonstimulant treatments for attention-deficit/hyperactivity disorder (ADHD). As nonstimulant treatments are often used after stimulants in ADHD, GXR was assessed relative to prior stimulant treatment in a randomized controlled trial (RCT), in which ATX was included as a reference arm, and in the open-label phase of a randomized-withdrawal study (RWS). Participants were 6–17 years old with ADHD Rating Scale version IV (ADHD-RS-IV) scores ≥32 and Clinical Global Impressions – Severity scores ≥4. RCT participants received dose-optimized GXR (1–7 mg/day), ATX (10–100 mg/day), or placebo for 10–13 weeks. RWS participants received dose-optimized GXR (1–7 mg/day) for 13 weeks. Participants’ last stimulant medication prior to enrolment, and reasons for stopping this medication, were collected at baseline. Change from baseline ADHD-RS-IV score and the proportion of responders were assessed by prior stimulant exposure. Of 163 RCT and 296 RWS participants who had previously received stimulant treatment, 142 and 224, respectively, had received methylphenidate (MPH); due to the low number of participants and the heterogeneity of non-MPH treatments, we only report data for prior MPH treatment. The most frequent reasons for stopping MPH were lack of effectiveness or side effects. Placebo-adjusted ADHD-RS-IV changes from baseline were significant in participants receiving GXR (prior MPH, −9.8, P<0.001, effect size [ES] 0.85; stimulant-naïve, −7.6, P<0.001, ES 0.65). In ATX-treated participants, significant placebo-adjusted differences were seen in stimulant-naïve (−5.0, P=0.022, ES 0.43) but not prior MPH-treated (−1.8, P>0.05, ES 0.15) participants. More participants met responder criteria with GXR versus placebo, regardless of prior treatment. GXR response was unaffected by prior stimulant treatment; ATX produced improvement only in stimulant-naïve participants relative to placebo. These findings may be relevant to clinical decision-making regarding sequencing of ADHD treatments. Keywords: ADHD, atomoxetine, GXR, inadequate responders, effectiveness, trial
format	article
author	Huss M Sikirica V Hervas A Newcorn JH Harpin V Robertson B
author_facet	Huss M Sikirica V Hervas A Newcorn JH Harpin V Robertson B
author_sort	Huss M
title	Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment
title_short	Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment
title_full	Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment
title_fullStr	Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment
title_full_unstemmed	Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment
title_sort	guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/e65a69e988d04e9195362dbd9342ad01
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Guanfacine extended release for children and adolescents with attention-deficit/hyperactivity disorder: efficacy following prior methylphenidate treatment

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