title: Effect of aripiprazole 2 to 15 mg/d on health-related quality of life in the treatment of irritability associated with autistic disorder in children: a post hoc analysis of two controlled trials.
abstract: BACKGROUND
  There are limited published data on the impact of treatment on the health-related quality of life (HRQOL) in individuals with autistic disorder.
  
  
  OBJECTIVE
  The aim of this study was to evaluate the impact of aripiprazole on HRQOL in the treatment of irritability in pediatric patients (aged 6-17 years) with autistic disorder.
  
  
  METHODS
  This post hoc analysis assessed data from two 8-week, double-blind, randomized, placebo-controlled studies that compared the efficacy of aripiprazole (fixed-dose study, 5, 10, and 15 mg/d; flexible-dose study, 2-15 mg/d) with placebo in the treatment of irritability associated with autistic disorder. HRQOL was assessed at baseline and week 8 using 3 Pediatric Quality of Life Inventory (PedsQL™) scales. Clinically relevant improvement in HRQOL was determined using an accepted distribution-based criterion-1 standard error of measurement.
  
  
  RESULTS
  In total, 316 patients were randomly assigned to receive treatment with aripiprazole (fixed-dose study, 166; flexible-dose study, 47) or placebo (fixed-dose study, 52; flexible-dose study, 51). Aripiprazole was associated with significantly greater improvement than placebo in PedsQL combined-scales total score (difference, 7.8; 95% CI, 3.8-11.8; P < 0.001) and in 3 PedsQL scale scores (differences [95% CI]: Emotional Functioning, 7.8 [3.4-12.2]; Social Functioning, 6.2 [0.7-11.8]; Cognitive Functioning, 9.3 [3.8-14.9]; all, P < 0.05). Patients who received aripiprazole were significantly more likely than those who received placebo to have a clinically meaningful improvement on the combined-scales total score (odds ratio [OR] = 1.9; 95% CI, 1.0-3.3; P < 0.05), Emotional Functioning scale (OR = 2.2; 95% CI, 1.2-4.0; P < 0.05) and Social Functioning scale (OR = 2.2; 95% CI, 1.2-4.1; P < 0.05), and were significantly less likely to experience deterioration (OR: 0.3, 95% CI: 0.1-0.8; P < 0.05) when "Stable" was used as the reference group.
  
  
  CONCLUSIONS
  The findings from the present post hoc analysis suggest that aripiprazole was associated with improved HRQOL, as assessed using 3 PedsQL scales, in pediatric patients with irritability associated with autistic disorder.
authors.affiliation: Department of Pediatrics, College of Medicine, Texas A&M University, College Station, Texas.
authors.forename: James W
authors.initials: JW
authors.lastname: Varni
authors.forename: Benjamin L
authors.initials: BL
authors.lastname: Handen
authors.forename: Patricia K
authors.initials: PK
authors.lastname: Corey-Lisle
authors.forename: Zhenchao
authors.initials: Z
authors.lastname: Guo
authors.forename: George
authors.initials: G
authors.lastname: Manos
authors.forename: Diane K
authors.initials: DK
authors.lastname: Ammerman
authors.forename: Ronald N
authors.initials: RN
authors.lastname: Marcus
authors.forename: Randall
authors.initials: R
authors.lastname: Owen
authors.forename: Robert D
authors.initials: RD
authors.lastname: McQuade
authors.forename: William H
authors.initials: WH
authors.lastname: Carson
authors.forename: Suja
authors.initials: S
authors.lastname: Mathew
authors.forename: Raymond
authors.initials: R
authors.lastname: Mankoski
mesh_terms: D000293:Adolescent; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068180:Aripiprazole; D001321:Autistic Disorder / Q000188:drug therapy*; D002648:Child; D004305:Dose-Response Relationship, Drug; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects*; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D015363:Quinolones / Q000008:administration & dosage / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
chemical_list: D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole