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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.

AbstractBACKGROUND:
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.
AuthorsJames W Varni, Benjamin L Handen, Patricia K Corey-Lisle, Zhenchao Guo, George Manos, Diane K Ammerman, Ronald N Marcus, Randall Owen, Robert D McQuade, William H Carson, Suja Mathew, Raymond Mankoski
JournalClinical therapeutics (Clin Ther) Vol. 34 Issue 4 Pg. 980-92 (Apr 2012) ISSN: 1879-114X [Electronic] United States
PMID22444782 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2012 Elsevier HS Journals, Inc. All rights reserved.
Chemical References
  • Antipsychotic Agents
  • Piperazines
  • Quinolones
  • Aripiprazole
Topics
  • Adolescent
  • Antipsychotic Agents (administration & dosage, therapeutic use)
  • Aripiprazole
  • Autistic Disorder (drug therapy)
  • Child
  • Dose-Response Relationship, Drug
  • Humans
  • Irritable Mood (drug effects)
  • Piperazines (administration & dosage, therapeutic use)
  • Quality of Life
  • Quinolones (administration & dosage, therapeutic use)
  • Randomized Controlled Trials as Topic

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