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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.
Clin Ther. 2012 Apr; 34(4):980-92.CT

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+Show Affiliations

Department of Pediatrics, College of Medicine, Texas A&M University, College Station, Texas.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22444782

Citation

Varni, James W., et al. "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." Clinical Therapeutics, vol. 34, no. 4, 2012, pp. 980-92.
Varni JW, Handen BL, Corey-Lisle PK, et al. 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. Clin Ther. 2012;34(4):980-92.
Varni, J. W., Handen, B. L., Corey-Lisle, P. K., Guo, Z., Manos, G., Ammerman, D. K., Marcus, R. N., Owen, R., McQuade, R. D., Carson, W. H., Mathew, S., & Mankoski, R. (2012). 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. Clinical Therapeutics, 34(4), 980-92. https://doi.org/10.1016/j.clinthera.2012.02.023
Varni JW, et al. 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. Clin Ther. 2012;34(4):980-92. PubMed PMID: 22444782.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Varni,James W, AU - Handen,Benjamin L, AU - Corey-Lisle,Patricia K, AU - Guo,Zhenchao, AU - Manos,George, AU - Ammerman,Diane K, AU - Marcus,Ronald N, AU - Owen,Randall, AU - McQuade,Robert D, AU - Carson,William H, AU - Mathew,Suja, AU - Mankoski,Raymond, Y1 - 2012/03/22/ PY - 2012/02/23/accepted PY - 2012/3/27/entrez PY - 2012/3/27/pubmed PY - 2012/8/7/medline SP - 980 EP - 92 JF - Clinical therapeutics JO - Clin Ther VL - 34 IS - 4 N2 - 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. SN - 1879-114X UR - https://www.unboundmedicine.com/medline/citation/22444782/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(12)00102-6 DB - PRIME DP - Unbound Medicine ER -