Short-Term Cardiovascular Effects of Mixed Amphetamine Salts Extended Release in Children and Adolescents With Oppositional Defiant Disorder

Abstract

AbstractObjectiveAssess cardiovascular effects of mixed amphetamine salts extended release (MAS XR) in children and adolescents (6–17 years of age) with oppositional defiant disorder (ODD).MethodsA 4-week, double-blind, randomized, placebo-controlled, forced dose-titration study of once-daily 10-, 20-, 30-, or 40-mg MAS XR (n=308). Resting/sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse were measured at baseline and weekly thereafter. Electrocardiograms (ECGs) were obtained at screening and study end point.FindingsAt study end point, mean changes in SBP and DBP were minimal with MAS XR (SBP: -0.2 to 1.1 mm Hg; DBP: -1.0 to 2.1 mm Hg) and comparable to placebo (SBP: -0.6 mm Hg; DBP: -0.4 mm Hg). Mean end point pulse was similar with MAS XR (80.6–84.7 bpm) and placebo (81.8 bpm). No dose-related trends in blood pressure and pulse changes were observed. No clinically significant changes in ECG parameters were seen with MAS XR. Changes in QTcB (Bazett's formula) interval with MAS XR were small (0.5 to 3.9 msec). No patient discontinued due to a cardiovascular adverse event.ConclusionCardiovascular effects of MAS XR (10–40 mg) were minimal and comparable to those with placebo in children and adolescents with ODD.