Long-Term Improvement and Safety of Aripiprazole for Irritability and Adaptive Function in Asian Children and Adolescents with Autistic Disorder: A 52-Week, Multinational, Multicenter, Open-Label Study
- Authors
- Kim, B.-U.[Kim, B.-U.]; Kim, H.-W.[Kim, H.-W.]; Park, E.J.[Park, E.J.]; Kim, J.-H.[Kim, J.-H.]; Boon-Yasidhi, V.[Boon-Yasidhi, V.]; Tarugsa, J.[Tarugsa, J.]; Reyes, A.[Reyes, A.]; Manalo, S.G.[Manalo, S.G.]; Joung, Y.-S.[Joung, Y.-S.]
- Issue Date
- 1-Sep-2022
- Publisher
- Mary Ann Liebert Inc.
- Keywords
- adaptive function; aripiprazole; children and adolescents; irritability; longterm effect
- Citation
- Journal of Child and Adolescent Psychopharmacology, v.32, no.7, pp.390 - 399
- Indexed
- SCIE
SCOPUS
- Journal Title
- Journal of Child and Adolescent Psychopharmacology
- Volume
- 32
- Number
- 7
- Start Page
- 390
- End Page
- 399
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/100857
- DOI
- 10.1089/cap.2022.0004
- ISSN
- 1044-5463
- Abstract
- Objective: Evaluate the long-term improvement and safety of aripiprazole in treating irritability in Asian children and adolescents (6–17 years) with autistic disorder. Methods: A 52-week, open-label, flexibly dosed (2–15 mg/day) study on the improvement and safety of aripiprazole in patients with autistic disorder who had completed an antecedent 12-week open-label study. The evaluation of efficacy was conducted using the Aberrant Behavior Checklist (ABC), Clinical Global Impression (CGI) scale, Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS), Vineland Adaptive Behavior Scale (VABS), and the Parenting Stress Index-Short Form (PSI-SF). Safety and tolerability measurements included adverse events, vital signs, electrocardiography, laboratory tests, body weight, and extrapyramidal symptoms (EPSs). Results: During the 52-week treatment, all effectiveness variables, including ABC, CGI, CY-BOCS, VABS, and PSI-SF scores, showed improvement. Regarding safety, the proportion of patients who experienced any treatment-emergent adverse events (TEAEs) was 58.62% (34/58 subjects, 75 cases). The most common TEAE was nasopharyngitis reported in 20.69% (15/58 subjects, 15 cases) and the other TEAE with an incidence of ‡10% was weight increases in 18.97% (11/58 subjects, 11 cases). Of them, 27.59% (16/58 subjects, 28 cases) experienced adverse drug reactions (ADRs). The most common ADR was weight increase reported in 15.52% (9/58 subjects, nine cases). The incidence of serious adverse events (SAEs) was 5.17% (3/ 58 subjects, three cases), which were epiphysiolysis, seizure, and a suicide attempt, but these were not ADRs. There were no clinically significant changes found in the evaluation of EPSs. Conclusions: Aripiprazole showed improvement for behavioral problems and adaptive functioning and was well tolerated in patients with autistic disorder until nearly a year after drug use. ª Mary Ann Liebert, Inc.
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