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


RESULTS
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.


CONCLUSIONS
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.
Biederman
Joseph
J
Massachusetts General Hospital, Harvard Medical School, Boston 02114, USA. jbiederman@partners.org
Spencer
Thomas J
TJ
Wilens
Timothy E
TE
Weisler
Richard H
RH
Read
Stephanie C
SC
Tulloch
Simon J
SJ
D000284:Administration, Oral; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000662:Amphetamines / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008134:Long-Term Care; D008297:Male; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome
D000662:Amphetamines; D003692:Delayed-Action Preparations