title: A community assessment, open-label study of the safety, tolerability, and effectiveness of mixed amphetamine salts extended release in school-age children with ADHD.
abstract: OBJECTIVE
  To assess the safety, tolerability, and effectiveness of mixed amphetamine salts extended release (MAS XR) in school-age children with attention-deficit/hyperactivity disorder (ADHD) treated in a community practice setting.
  
  
  METHODS
  Children aged 6-12 years (N = 2968) with DSM-IV-defined ADHD entered a 9-week prospective, open-label, non-comparative study of MAS XR at 386 sites. For at least 2 weeks before enrollment, subjects with well-controlled ADHD received their consistent dose of previously prescribed psychostimulant. Subsequently, this regimen was converted to an equivalent once-daily dose of 10-, 20-, or 30-mg MAS XR, according to a conversion algorithm. Tolerability and safety were assessed based on reported treatment-emergent adverse events and observed changes in vital signs and body weight. Effectiveness was assessed using a parent-completed Conners' Global Index Scale (CGIS-P) measured 8 and 12 h postdose and a clinician-scored Clinical Global Impressions-Improvement (CGI-I) scale after 1, 3, and 7 weeks of treatment. The dose of study medication could be adjusted at weeks 1 and 3 to a maximum of 40 mg/day. Outcome analyses used an intent-to-treat methodology, with last observations carried forward.
  
  
  RESULTS
  Statistically significant improvement in ADHD behavior 8 and 12 h postdose occurred during the first week of treatment and was maintained through study endpoint (p < 0.0001). Results of the investigator-rated CGI-I at weeks 1, 3, and 7 were consistent with the parent-rated CGIS-P results, indicating that MAS XR treatment significantly improved symptoms compared with the baseline stimulant regimen (p < 0.0001). The incidence of treatment-related adverse events was low, and most AEs were mild in intensity.
  
  
  CONCLUSIONS
  MAS XR 10-40 mg is a safe and effective once-daily medication for treatment of children with ADHD in a community practice setting. ADHD symptoms may be further reduced by converting from current pharmacotherapy to an optimally titrated dose of MAS XR.
authors.affiliation: Drexel University College of Medicine, Philadelphia, PA 19124, USA. paul.ambrosini@drexelmed.edu
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Ambrosini
authors.forename: Floyd R
authors.initials: FR
authors.lastname: Sallee
authors.forename: Frank A
authors.initials: FA
authors.lastname: Lopez
authors.forename: Li
authors.initials: L
authors.lastname: Shi
authors.forename: M Alex
authors.initials: MA
authors.lastname: Michaels
mesh_terms: D000662:Amphetamines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D003153:Community Health Services; D003692:Delayed-Action Preparations; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome; D014481:United States
chemical_list: D000662:Amphetamines; D003692:Delayed-Action Preparations