title: 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.
  
  
  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.
authors.affiliation: Massachusetts General Hospital, Harvard Medical School, Boston 02114, USA. jbiederman@partners.org
authors.forename: Joseph
authors.initials: J
authors.lastname: Biederman
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Spencer
authors.forename: Timothy E
authors.initials: TE
authors.lastname: Wilens
authors.forename: Richard H
authors.initials: RH
authors.lastname: Weisler
authors.forename: Stephanie C
authors.initials: SC
authors.lastname: Read
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Tulloch
mesh_terms: 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
chemical_list: D000662:Amphetamines; D003692:Delayed-Action Preparations