title: Adverse events in medication treatment-naïve children with attention-deficit/hyperactivity disorder: results from a small, controlled trial of lisdexamfetamine dimesylate.
abstract: OBJECTIVE
  To evaluate the type, frequency, duration, and severity of treatment emergent adverse events (TEAEs) of the prodrug lisdexamfetamine dimesylate (LDX) in children with and without previous exposure to stimulant medication in the treatment of attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  This single-blind, modified laboratory school study used open-label, dose optimization of children aged 6-12 years. LDX, initiated at 30 mg, was dose titrated in 20 mg increments to a possible 70 mg over 4-5 weeks. Safety was assessed using adverse effects and LDX levels.
  
  
  RESULTS
  Twenty-eight subjects enrolled in the study, with 27 safety protocol completers (n=14 previous stimulant exposure; n=13 stimulant naïve). The stimulant-naïve group reported more trouble sleeping, stomach pain, and hyperfocus, but only previous-exposure subjects experienced dizziness. Previous-exposure subjects showed trends of more decreased appetite, less talkativeness, and less lip sucking. There were no differences in the mean duration of TEAEs. The epidemiological method of percent person-weeks applied to ADHD treatment offers a novel approach to interpreting the pattern of TEAEs.
  
  
  CONCLUSIONS
  LDX reduced the core symptoms of ADHD with more severe adverse events in stimulant-naïve than previous-exposure subjects. Future controlled studies with larger samples should address the impact of previous stimulant exposure on other ADHD treatments.
authors.affiliation: Child Development Center, Department of Pediatrics, University of California, Irvine, Irvine, California 92612, USA. sbwigal@uci.edu
authors.forename: Sharon B
authors.initials: SB
authors.lastname: Wigal
authors.forename: Amanda A
authors.initials: AA
authors.lastname: Wong
authors.forename: Angela
authors.initials: A
authors.lastname: Jun
authors.forename: Annamarie
authors.initials: A
authors.lastname: Stehli
authors.forename: Robin
authors.initials: R
authors.lastname: Steinberg-Epstein
authors.forename: Marc A
authors.initials: MA
authors.lastname: Lerner
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D003913:Dextroamphetamine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D016037:Single-Blind Method
chemical_list: D000697:Central Nervous System Stimulants; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine