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

Published online by Cambridge University Press:  07 November 2014

Daniel F. Connor  and
Thomas J. Spencer
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Abstract

Objective

Assess cardiovascular effects of mixed amphetamine salts extended release (MAS XR) in children and adolescents (6–17 years of age) with oppositional defiant disorder (ODD).

Methods

A 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.

Findings

At 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.

Conclusion

Cardiovascular effects of MAS XR (10–40 mg) were minimal and comparable to those with placebo in children and adolescents with ODD.

Type
Academic Supplement
Information
CNS Spectrums , Volume 10 , Issue S15: Mixed Amphetamine Salts Extended Release for the Treatment of ADHD in Adolescents: Current Evidence , October 2005 , pp. 31 - 38
Copyright
Copyright © Cambridge University Press 2005

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