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

BackgroundThere are limited published data on the impact of treatment on the health-related quality of life (HRQOL) in individuals with autistic disorder.ObjectiveThe 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.MethodsThis 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.ResultsIn 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.ConclusionsThe 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.