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Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change.
J Child Adolesc Psychopharmacol. 2013 Oct; 23(8):572-6.JC

Abstract

OBJECTIVE

The purpose of this study was to evaluate the impact of prior antipsychotic exposure (PAE) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment.

METHODS

This study was a post-hoc analysis of pooled data from two 8-week, double-blind, randomized, placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder, aged 6-17 years. Subjects were stratified by PAE; adverse events (AEs), and changes in weight, and metabolic measures were evaluated. For subjects receiving aripiprazole, regardless of PAE, baseline weight, age, gender, and symptom severity were evaluated in a regression model predicting body weight change.

RESULTS

Of 316 randomized subjects, 259 (82.0%) were antipsychotic naïve (AN) and 57 (18.0%) had a PAE. Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence (11.9% vs. 2.8%), sedation (22.7% vs. 11.1%), or fatigue (17.0% vs. 13.9%). Rates of extrapyramidal disorder and drooling, but not akathisia or tremor, were marginally higher in AN subjects. Overall, 10.8% of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3% of aripiprazole-treated PAE subjects. AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo (1.9 vs. 0.7 kg; treatment difference 1.2 kg, 95% CI: 0.5, 1.9) than PAE subjects receiving aripiprazole compared with subjects receiving placebo (0.4 vs. -0.4 kg; treatment difference 0.9 kg, 95% CI: -0.6, 2.4). Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain. There were no significant changes in metabolic measures compared with placebo in either group.

CONCLUSIONS

Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score. AN subjects were more likely to experience AEs related to somnolence. However, based on discontinuations rates from AEs, overall tolerability was good for both AN and PAE groups.

CLINICAL TRIAL REGISTRATION

Study of aripiprazole in the treatment of children and adolescents with autistic disorder. Registry: www.clinicaltrials.gov . Identifiers: NCT00332241 and NCT00337571.

Authors+Show Affiliations

1 Bristol-Myers Squibb , Plainsboro, NJ.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24138011

Citation

Mankoski, Raymond, et al. "Aripiprazole Treatment of Irritability Associated With Autistic Disorder and the Relationship Between Prior Antipsychotic Exposure, Adverse Events, and Weight Change." Journal of Child and Adolescent Psychopharmacology, vol. 23, no. 8, 2013, pp. 572-6.
Mankoski R, Stockton G, Manos G, et al. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. J Child Adolesc Psychopharmacol. 2013;23(8):572-6.
Mankoski, R., Stockton, G., Manos, G., Marler, S., McQuade, R., Forbes, R. A., & Marcus, R. (2013). Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. Journal of Child and Adolescent Psychopharmacology, 23(8), 572-6. https://doi.org/10.1089/cap.2012.0075
Mankoski R, et al. Aripiprazole Treatment of Irritability Associated With Autistic Disorder and the Relationship Between Prior Antipsychotic Exposure, Adverse Events, and Weight Change. J Child Adolesc Psychopharmacol. 2013;23(8):572-6. PubMed PMID: 24138011.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. AU - Mankoski,Raymond, AU - Stockton,Gwen, AU - Manos,George, AU - Marler,Sabrina, AU - McQuade,Robert, AU - Forbes,Robert A, AU - Marcus,Ronald, PY - 2013/10/22/entrez PY - 2013/10/22/pubmed PY - 2014/5/27/medline SP - 572 EP - 6 JF - Journal of child and adolescent psychopharmacology JO - J Child Adolesc Psychopharmacol VL - 23 IS - 8 N2 - OBJECTIVE: The purpose of this study was to evaluate the impact of prior antipsychotic exposure (PAE) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment. METHODS: This study was a post-hoc analysis of pooled data from two 8-week, double-blind, randomized, placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder, aged 6-17 years. Subjects were stratified by PAE; adverse events (AEs), and changes in weight, and metabolic measures were evaluated. For subjects receiving aripiprazole, regardless of PAE, baseline weight, age, gender, and symptom severity were evaluated in a regression model predicting body weight change. RESULTS: Of 316 randomized subjects, 259 (82.0%) were antipsychotic naïve (AN) and 57 (18.0%) had a PAE. Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence (11.9% vs. 2.8%), sedation (22.7% vs. 11.1%), or fatigue (17.0% vs. 13.9%). Rates of extrapyramidal disorder and drooling, but not akathisia or tremor, were marginally higher in AN subjects. Overall, 10.8% of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3% of aripiprazole-treated PAE subjects. AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo (1.9 vs. 0.7 kg; treatment difference 1.2 kg, 95% CI: 0.5, 1.9) than PAE subjects receiving aripiprazole compared with subjects receiving placebo (0.4 vs. -0.4 kg; treatment difference 0.9 kg, 95% CI: -0.6, 2.4). Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain. There were no significant changes in metabolic measures compared with placebo in either group. CONCLUSIONS: Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score. AN subjects were more likely to experience AEs related to somnolence. However, based on discontinuations rates from AEs, overall tolerability was good for both AN and PAE groups. CLINICAL TRIAL REGISTRATION: Study of aripiprazole in the treatment of children and adolescents with autistic disorder. Registry: www.clinicaltrials.gov . Identifiers: NCT00332241 and NCT00337571. SN - 1557-8992 UR - https://www.unboundmedicine.com/medline/citation/24138011/Aripiprazole_treatment_of_irritability_associated_with_autistic_disorder_and_the_relationship_between_prior_antipsychotic_exposure_adverse_events_and_weight_change_ L2 - https://www.liebertpub.com/doi/full/10.1089/cap.2012.0075?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -