Long-term safety and effectiveness of mixed amphetamine salts extended release in adults with ADHD.

Abstract

OBJECTIVE:

Assess the long-term safety and effectiveness of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD) combined subtype.

METHODS:

A 24-month, open-label extension of a 4-week, multicenter, double-blind, placebo-controlled, parallel-group, forced-dose-escalation study of MAS XR in adults (>or=18 years of age) with ADHD. The 223 enrolled subjects started treatment at 20 mg/day for 1 week, with subsequent titration up to 60 mg/day for optimal therapeutic effects. At monthly visits, efficacy was assessed based on the ADHD Rating Scale IV (ADHD-RS-IV). Safety assessments included spontaneously reported adverse events, laboratory assessments, and monitoring of vital signs.

FINDINGS:

ADHD symptoms significantly improved for all subjects as measured by change from baseline in mean ADHD-RS-IV total scores (-7.2+/-13.04 unit points; P<.001); this was sustained for up to 24 months. The most common treatment-related adverse events were dry mouth (43% of subjects reporting at least one occurrence), infection (33%), insomnia (32%), anorexia/decreased appetite (32%), headache (30%), and nervousness (26%). Most adverse events were mild to moderate in intensity.

CONCLUSION:

Treatment with MAS XR 20-60 mg/day for adult ADHD was generally well tolerated and was associated with sustained symptomatic improvement for up to 24 months.

• Authors: Joseph Biederman, Thomas J Spencer, Timothy E Wilens, Richard H Weisler, Stephanie C Read, Simon J Tulloch, SLI381.304 study group
• Journal: CNS spectrums (CNS Spectr) Vol. 10 Issue 12 Suppl 20 Pg. 16-25 (Dec 2005) ISSN: 1092-8529 [Print] United States
• PMID: 16344837 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Amphetamines
• Delayed-Action Preparations

Topics

• Administration, Oral
• Adult
• Adverse Drug Reaction Reporting Systems
• Amphetamines (adverse effects, therapeutic use)
• Attention Deficit Disorder with Hyperactivity (drug therapy, psychology)
• Delayed-Action Preparations
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Long-Term Care
• Male
• Quality of Life (psychology)
• Treatment Outcome