Acute and Long-Term Cardiovascular Effects of Stimulant, Guanfacine, and Combination Therapy for Attention-Deficit/Hyperactivity Disorder

By Sayer, Gregory R.; McGough, James J. et al. | Journal of Child and Adolescent Psychopharmacology, December 2016 | Go to article overview

Acute and Long-Term Cardiovascular Effects of Stimulant, Guanfacine, and Combination Therapy for Attention-Deficit/Hyperactivity Disorder


Sayer, Gregory R., McGough, James J., Levitt, Jennifer, Cowen, Jennifer, Sturm, Alexandra, Castelo, Edward, McCracken, James T., Journal of Child and Adolescent Psychopharmacology


[Author Affiliation]

Gregory R. Sayer. Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California.

James J. McGough. Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California.

Jennifer Levitt. Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California.

Jennifer Cowen. Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California.

Alexandra Sturm. Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California.

Edward Castelo. Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California.

James T. McCracken. Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, Los Angeles, California.

Funding: This project was conducted under an NIMH Grant P50MH77248 (J.T.M., PI).

Address correspondence to: James J. McGough, MD, Division of Child and Adolescent Psychiatry, UCLA Semel Institute for Neuroscience and Human Behavior, 300 UCLA Medical Plaza, Suite 1524C, Los Angeles, CA 90095, E-mail: jmcgough@mednet.ucla.edu

Introduction

Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral disorder of childhood, with an estimated prevalence in the range of 9% of school-age youth (Polanczyk et al. 2007; Wolraich et al. 2012). ADHD is not isolated to childhood and persists in 30%-70% of patients into adulthood. Treating ADHD is compelled by studies showing that symptoms impact nearly all domains of functioning (Barkley et al. 2006; Kessler et al. 2006; Biederman et al. 2012; Miller et al. 2013).

Psychostimulant medications, including various formulations of methylphenidate (MPH) or amphetamine (AMPH), continue to be the mainstay of ADHD pharmacotherapy, with an estimated 3.5 million children receiving prescriptions annually in 2011 (Visser et al. 2014). Psychostimulants as monotherapy produce a robust improvement in symptoms in the short term with responder rates of 65%-75% (Steele et al. 2006; Heal et al. 2012) and approximately full syndrome remission described in roughly half of treated youth (Swanson et al. 2001). Second-tier options for ADHD monotherapy include the norepinephrine reuptake inhibitor atomoxetine as well as the alpha-2 agonists, guanfacine (GUAN) and clonidine. FDA has granted approval for GUAN extended-release (GUAN-XR) and clonidine extended-release formulations as ADHD therapies. Controlled trials of GUAN-XR suggest response rates of 50%-65% during acute treatment (Biederman et al. 2008; Sallee et al. 2009).

Recognition of the negative impact of untreated ADHD symptoms (Biederman et al. 1998) and concomitant wishes to maximize treatment response and higher rates of remission have led investigators to examine possible benefits of adjunctive alpha-2 agonist therapy in patients exhibiting partial stimulant responses (Spencer et al. 2009; Wilens et al. 2012). Efficacy and safety data from these studies are largely limited to short-term trials conducted with extended-release formulations in stimulant-refractory samples.

Despite their long history of frequent use, there have been ongoing concerns raised about the cardiovascular (CV) safety of ADHD medications, particularly for psychostimulants (Martinez-Raga et al. 2013). Specifically, the possible association of stimulant medication use and increased risk for sudden cardiac death, potential links to corrected QT (QTc) interval prolongation on electrocardiogram (EKG), and risk of arrhythmia have prompted U.S. Food and Drug Administration (FDA) reviews and several independent reports. A black box warning on potential cardiac risks was debated, but ultimately not implemented by the FDA due to lack of support for an association. …

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