By Deborah Brauser
HONOLULU -- November 5, 2009 -- Guanfacine extended release (ER) significantly reduces oppositional symptoms – such as anger, hostility, irritability, arguing, and refusing to comply with rules set by adults -- in children with attention-deficit/hyperactivity disorder (ADHD), according to a new randomised study presented at the American Academy of Child and Adolescent Psychiatry (AACAP) 56th Annual Meeting.
Approximately 60% of ADHD patients have accompanying oppositional symptoms, reported Floyd R. Sallee, MD, PhD, University of Cincinnati, Cincinnati, Ohio, during a poster session here on October 29. "But few studies have evaluated change in oppositional symptoms in children with ADHD as a primary endpoint."
In this 9-week study, 214 children aged 6 to 12 years were randomised 2:1 to receive either a flexible dose (1 to 4 mg per day) of guanfacine (n = 136; 64% male; mean age, 9.4 years) or matching placebo (n = 78; 76.9% male; mean age, 9.3).
The primary outcome was the change from baseline to endpoint on the oppositional subscale from the Conners' Parent Rating Scale-Revised Long Form (CPRS-RL). The secondary outcome was the effect on ADHD symptoms, measured by the change from baseline to endpoint on the ADHD Rating Scale IV (ADHD-RS-IV). The investigators also conducted safety assessments.
Study results demonstrated that the guanfacine group was associated with significantly greater improvements in the CPRS-RL oppositional subscale with a mean change from baseline of -10.9 versus -6.8 for the placebo group (effect size, 0.59; P < .001).
Patients treated with guanfacine also experienced a greater mean reduction from baseline in the ADHD-RS-IV total score of -23.8 versus -11.5 for subjects given placebo (effect size, 0.92; P < .001).
A total of 83.8% of the guanfacine patients and 57.7% of the placebo subjects reported treatment-emergent adverse events (TEAEs), with most being mild to moderate. The most commonly reported TEAEs in the guanfacine group were somnolence (50.7%), headache (22.1%), sedation (13.2%), upper abdominal pain (11.8%), and fatigue (11.0%). No serious TEAEs were reported in either group.
"These results support the efficacy of guanfacine in the treatment of children with ADHD with oppositional symptoms, with generally mild to moderate adverse events, and warrants further investigation," Dr. Sallee summarised.
Funding for this study was provided by Shire Development Inc.
[Presentation title: Effects of Guanfacine Extended Release in Children Aged 6 to 12 With Oppositional Symptoms and a Diagnosis of ADHD. Abstract P-3.8]
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