Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial.

摘要: Abstract Objective This study compared the efficacy of guanfacine extended release (GXR), a selective α 2A -adrenoceptor agonist, with placebo in children and adolescents attention-deficit/hyperactivity disorder (ADHD). Method double-blind, 9-week, dose-ranging, parallel-design, multicenter trial randomized 6- to 17-year-olds ADHD once-daily oral GXR 1 -, 2-, 3-, 4-mg doses or placebo. Primary outcome was change total Rating Scale–IV score from baseline endpoint. Secondary outcomes included changes scores hyperactive/impulsive inattentive subscales; clinician parent ratings; duration clinical effect; safety measures. Results Statistically significant reductions Scale-IV were observed endpoint at all GXR, effect sizes ranging 0.43 0.62. In subjects receiving mean heart rate systolic diastolic blood pressure decreased as dose increased then returned toward during dose-maintenance dose-tapering phases trial. Most frequent treatment-emergent adverse events (≥ 5%) somnolence, headache, fatigue, sedation, dizziness, irritability, upper abdominal pain, nausea. Somnolence, fatigue emerged within first 2 weeks dosing generally resolved by end. Conclusions Guanfacine extended-release effective reducing symptoms ADHD. Adverse mild moderate, did not interfere improvements attention, rarely led discontinuation.