| An open-label study of the tolerability of mixed amphetamine salts in adults with attention-deficit/hyperactivity disorder and treated primary essential hypertension. | |
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MedLine Citation:
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PMID: 16841618 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Timothy E Wilens; Randall M Zusman; Paul G Hammerness; Amy Podolski; Julia Whitley; Thomas J Spencer; Martin Gignac; Joseph Biederman |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Journal of clinical psychiatry Volume: 67 ISSN: 0160-6689 ISO Abbreviation: J Clin Psychiatry Publication Date: 2006 May |
Date Detail:
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Created Date: 2006-07-17 Completed Date: 2006-08-02 Revised Date: 2007-11-14 |
Medline Journal Info:
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Nlm Unique ID: 7801243 Medline TA: J Clin Psychiatry Country: United States |
Other Details:
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Languages: eng Pagination: 696-702 Citation Subset: IM |
Affiliation:
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Pediatric Psychopharmacology Unit, Massachusetts General Hospital, Boston 02114, USA. twilens@partners.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Age Factors Amphetamines / adverse effects, pharmacology, therapeutic use* Antihypertensive Agents / therapeutic use Attention Deficit Disorder with Hyperactivity / diagnosis, drug therapy*, epidemiology Blood Pressure / drug effects* Blood Pressure Determination Central Nervous System Stimulants / adverse effects, pharmacology, therapeutic use* Comorbidity Delayed-Action Preparations Drug Therapy, Combination Electrocardiography / statistics & numerical data Female Heart Rate / drug effects Humans Hypertension / drug therapy*, epidemiology Male Mental Disorders / diagnosis, epidemiology Psychiatric Status Rating Scales Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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K24 DA016264/DA/NIDA NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Amphetamines; 0/Antihypertensive Agents; 0/Central Nervous System Stimulants; 0/Delayed-Action Preparations; 0/SLI381 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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