title: Efficacy and safety of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder and recent methylphenidate use.
abstract: BACKGROUND
  Lisdexamfetamine dimesylate (LDX) is a long-acting prodrug stimulant for the treatment of attention-deficit/hyperactivity disorder (ADHD). Post hoc subgroup analyses were performed from two studies in children with ADHD to compare the efficacy of LDX in participants who had received prior methylphenidate (MPH) treatment with that of the overall study populations.
  
  
  METHODS
  Study 1 (7-week; open-label design) and study 2 (randomized, double-blind, placebo-controlled, crossover, laboratory school design) enrolled children aged 6-12 years with ADHD and baseline ADHD Rating Scale IV (ADHD-RS-IV) total score ≥28. Both studies excluded children whose prestudy ADHD treatment provided effective control of ADHD symptoms with an acceptable safety profile. Post hoc efficacy analyses were performed in children who had received MPH within 6 months of study enrollment. Efficacy measures included the following scales: ADHD-RS-IV, Clinical Global Impressions-Improvement (CGI-I), Expression and Emotion Scale for Children (EESC), Behavior Rating Inventory of Executive Function (BRIEF), Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP), and Permanent Product Measure of Performance (PERMP).
  
  
  RESULTS
  In studies 1 and 2, 83/318 (26%) and 67/129 (52%) participants, respectively, had received MPH within 6 months and were not adequately controlled on current medication with acceptable tolerability; most of these participants had received long-acting MPH. In prior MPH participants, efficacy assessments demonstrated improvements from baseline (study 1) and versus placebo (study 2) that were comparable with those seen in the respective overall study population. Safety profiles were consistent with long-acting stimulant use.
  
  
  CONCLUSIONS
  In two studies, children who had received prior MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study populations. For children with ADHD who were previously treated with MPH, LDX may, therefore, be an efficacious treatment option.
authors.affiliation: R/D Clinical Research, Inc, 461 This Way, Lake Jackson, TX 77566, USA. jaintexas@gmail.com
authors.forename: Rakesh
authors.initials: R
authors.lastname: Jain
authors.forename: Thomas
authors.initials: T
authors.lastname: Babcock
authors.forename: Teodor
authors.initials: T
authors.lastname: Burtea
authors.forename: Bryan
authors.initials: B
authors.lastname: Dirks
authors.forename: Ben
authors.initials: B
authors.lastname: Adeyi
authors.forename: Brian
authors.initials: B
authors.lastname: Scheckner
authors.forename: Robert
authors.initials: R
authors.lastname: Lasser
authors.forename: John
authors.initials: J
authors.lastname: Renna
authors.forename: Don
authors.initials: D
authors.lastname: Duncan
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D018592:Cross-Over Studies; D003913:Dextroamphetamine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use; D011355:Prodrugs / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D011355:Prodrugs; D008774:Methylphenidate; D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine