Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in children.
OBJECTIVE
To assess the short- and long-term cardiovascular effects of once-daily treatment with a mixed amphetamine salts extended-release formulation (MAS XR; Adderall XR(R)) in children age 6 to 12 years with attention-deficit/hyperactivity disorder (ADHD).


METHODS
Short-term cardiovascular effects were assessed during a 4-week, double-blind, randomized, placebo-controlled, forced-dose-titration study of once-daily 10, 20, and 30 mg MAS XR (n = 580). Long-term cardiovascular effects were assessed in 568 subjects during a 2-year, open-label extension study of MAS XR (10 to 30 mg/day). Resting sitting blood pressure and pulse were measured at baseline and weekly during the short-term study, then monthly during long-term treatment.


RESULTS
Changes in blood pressure, pulse, and QT interval corrected by Bazett's formula (QTcB) in children receiving MAS XR were not statistically significantly different than those changes seen in children receiving placebo during short-term treatment. Mean increases in blood pressure after 2 years of MAS XR treatment (systolic, 3.5 mm Hg; diastolic, 2.6 mm Hg) and pulse (3.4 bpm) were clinically insignificant, and there was no apparent dose-response relationship.


CONCLUSIONS
Cardiovascular effects of short- and long-term MAS XR were minimal during short- and long-term MAS XR treatment at doses of </= 30 mg/day in otherwise healthy children.
Findling
Robert L
RL
University Hospitals of Cleveland, Cleveland, Ohio 44106-5080, USA. Robert.Findling@uhhs.com
Biederman
Joseph
J
Wilens
Timothy E
TE
Spencer
Thomas J
TJ
McGough
James J
JJ
Lopez
Frank A
FA
Tulloch
Simon J
SJ
D000662:Amphetamines / Q000008:administration & dosage*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy / Q000503:physiopathology*; D001794:Blood Pressure / Q000187:drug effects*; D002648:Child; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004562:Electrocardiography; D005260:Female; D006339:Heart Rate / Q000187:drug effects*; D006801:Humans; D008297:Male
D000662:Amphetamines; D003692:Delayed-Action Preparations; C449521:SLI381