Effects of Guanfacine Extended Release on Oppositional Symptoms in Children Aged 6-12 Years with Attention-Deficit Hyperactivity Disorder and Oppositional Symptoms

Connor, Daniel F.; Findling, Robert L.; Kollins, Scott H.; Sallee, Floyd; Lopez, Frank A.; Lyne, Andrew; Tremblay, Gerald
September 2010
CNS Drugs;2010, Vol. 24 Issue 9, p755
Academic Journal
Objective: To evaluate the efficacy and safety of guanfacine extended release (XR, Intunivâ„¢; Shire Development Inc., Wayne, PA, USA) in the treatment of oppositional symptoms in children aged 6-12 years with a diagnosis of attention-deficit hyperactivity disorder (ADHD) and the presence of oppositional symptoms. Subjects and Methods: In this randomized, double-blind, placebo-controlled, multicentre, flexible-dose, dose-optimization study, children aged 6-12 years were randomized to receive guanfacine XR (1-4 mg/day) or placebo for 9 weeks. Screening and washout periods were followed by a 5-week dose-optimization period, a 3-week dose-maintenance period and a 1-week tapering period. The primary efficacy measure was change from baseline to endpoint in the oppositional subscale of the Conners' Parent Rating Scale-Revised: Long Form (CPRS-R:L) score. Change in ADHD Rating Scale IV (ADHD-RS-IV) total score was a secondary efficacy measure. Safety assessments included adverse events (AEs), vital signs, ECG readings and laboratory studies. Results: A total of217 children were enrolled: 138 were randomized to receive guanfacine XR and 79 to receive placebo. Least-squares mean reductions from baseline to endpoint in CPRS-R:L oppositional subscale scores were 10.9 in the guanfacine XR group compared with 6.8 in the placebo group (p<0.00l; effect size=0.59). A significantly greater reduction in ADHDRS-IV total score from baseline to endpoint was also seen in the.guanfacinetreated group compared with the placebo group (23.8 vs 11.5, respectively; p


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