An Open-Label Study of the Tolerability of Mixed Amphetamine Salts in Adults With Attention-Deficit/Hyperactivity Disorder and Treated Primary Essential Hypertension
J Clin Psychiatry 2006;67(5):696-702
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Objective: To evaluate the short-term
tolerability of an extended-release preparation of the
stimulant medication mixed amphetamine salts (MAS XR)
in adults with attention-deficit/hyperactivity
disorder (ADHD) whose hypertension has been
successfully treated with antihypertensive medications.
Method: An 8-week, 2-phase, open-label
study design was implemented. All adults had ADHD (DSM-IV diagnosis) and essential hypertension
and were required to be normotensive (blood
pressure < 135/85 mm Hg, treated) for at least 4 weeks
at entry into the study. MAS XR was given for a 6-week period, titrated once each week to a
target maximum dose of 60 mg/day given once daily
in the morning (phase 1), and then discontinued for
2 weeks at the end of the study (phase 2). At
baseline, subjects underwent a comprehensive clinical
assessment, medical history, vital signs assessment,
and electrocardiogram (ECG). Rating scales were
used throughout the study to assess response to
treatment, and blood pressure was measured manually
at each study visit. The primary outcome was the
effect of MAS XR on blood pressure and the development of hypertension.
Results: Thirteen subjects receiving
antihypertensive therapy were entered and placed on
MAS XR treatment and completed the trial. There
were no serious adverse events. No sustained
elevated blood pressure (> 140/90 mm Hg at 2
consecutive visits) was observed in the subjects treated
with MAS XR. Similar rates of single episodes of
hypertension were observed in phases 1 and 2.
Similarly, there was no group mean increase in systolic or
diastolic blood pressure or pulse during treatment
with MAS XR. No clinically significant changes in
the ECG were observed. During the 6-week
medication phase, significant improvement was found on
rating scales assessing ADHD symptoms and severity
that reversed with discontinuation of MAS XR.
Conclusion: The results of this open study
suggest that adults with ADHD and controlled hypertension can be safely treated with MAS XR.