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The effects of aripiprazole on electrocardiography in children with pervasive developmental disorders.
J Child Adolesc Psychopharmacol. 2012 Aug; 22(4):277-83.JC

Abstract

OBJECTIVES

Psychotropic medications, including the atypical antipsychotics, have historically been scrutinized for cardiac effects and risk of sudden death. Aripiprazole is an atypical antipsychotic approved for pediatric use in schizophrenia, bipolar I disorder, and autistic disorder. Adult studies have evaluated aripiprazole's effects on electrocardiograms, but no pediatric studies have been published to date.

METHODS

Electrocardiographic data were collected from children and adolescents participating in a 14-week, prospective, open-label study (n=25) of aripiprazole for irritability in pervasive developmental disorder not otherwise specified and Asperger's disorder. A 12-lead electrocardiogram was obtained at the baseline and end point visits. The electrocardiograms were evaluated for abnormal findings, and the PR, QRS, QT(c), and RR intervals were recorded. The QT interval was corrected using Bazett's, United States Food and Drug Administration (FDA) Pharmacology Division, and Fridericia's formulas.

RESULTS

Twenty-four subjects received both baseline and posttreatment electrocardiograms. The mean age was 8.6 years (range 5-17 years). The average final aripiprazole dose was 7.8 mg/day (range 2.5-15 mg/day). There were no significant differences noted with the PR, QRS, RR, and QT(c) intervals after aripiprazole therapy. Also, there was no significant correlation between the dose given and the percent change in the QT(c). No post-treatment QT(c) exceeded 440 ms.

CONCLUSIONS

To our knowledge, this is the first systematic evaluation of the cardiac effects of aripiprazole in children and adolescents. The results are consistent with previously published literature in adults that aripiprazole has no significant cardiac effects and can be deemed a low risk for causing sudden death. It will be important to confirm these findings in a randomized controlled trial.

Authors+Show Affiliations

Section of Pediatric Cardiology, Department of Pediatrics, James Whitcomb Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, Indiana 46202-5200, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Controlled Clinical Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22849533

Citation

Ho, Jason G., et al. "The Effects of Aripiprazole On Electrocardiography in Children With Pervasive Developmental Disorders." Journal of Child and Adolescent Psychopharmacology, vol. 22, no. 4, 2012, pp. 277-83.
Ho JG, Caldwell RL, McDougle CJ, et al. The effects of aripiprazole on electrocardiography in children with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2012;22(4):277-83.
Ho, J. G., Caldwell, R. L., McDougle, C. J., Orsagh-Yentis, D. K., Erickson, C. A., Posey, D. J., & Stigler, K. A. (2012). The effects of aripiprazole on electrocardiography in children with pervasive developmental disorders. Journal of Child and Adolescent Psychopharmacology, 22(4), 277-83. https://doi.org/10.1089/cap.2011.0129
Ho JG, et al. The Effects of Aripiprazole On Electrocardiography in Children With Pervasive Developmental Disorders. J Child Adolesc Psychopharmacol. 2012;22(4):277-83. PubMed PMID: 22849533.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of aripiprazole on electrocardiography in children with pervasive developmental disorders. AU - Ho,Jason G, AU - Caldwell,Randall L, AU - McDougle,Christopher J, AU - Orsagh-Yentis,Danielle K, AU - Erickson,Craig A, AU - Posey,David J, AU - Stigler,Kimberly A, Y1 - 2012/07/31/ PY - 2012/8/2/entrez PY - 2012/8/2/pubmed PY - 2013/1/17/medline SP - 277 EP - 83 JF - Journal of child and adolescent psychopharmacology JO - J Child Adolesc Psychopharmacol VL - 22 IS - 4 N2 - OBJECTIVES: Psychotropic medications, including the atypical antipsychotics, have historically been scrutinized for cardiac effects and risk of sudden death. Aripiprazole is an atypical antipsychotic approved for pediatric use in schizophrenia, bipolar I disorder, and autistic disorder. Adult studies have evaluated aripiprazole's effects on electrocardiograms, but no pediatric studies have been published to date. METHODS: Electrocardiographic data were collected from children and adolescents participating in a 14-week, prospective, open-label study (n=25) of aripiprazole for irritability in pervasive developmental disorder not otherwise specified and Asperger's disorder. A 12-lead electrocardiogram was obtained at the baseline and end point visits. The electrocardiograms were evaluated for abnormal findings, and the PR, QRS, QT(c), and RR intervals were recorded. The QT interval was corrected using Bazett's, United States Food and Drug Administration (FDA) Pharmacology Division, and Fridericia's formulas. RESULTS: Twenty-four subjects received both baseline and posttreatment electrocardiograms. The mean age was 8.6 years (range 5-17 years). The average final aripiprazole dose was 7.8 mg/day (range 2.5-15 mg/day). There were no significant differences noted with the PR, QRS, RR, and QT(c) intervals after aripiprazole therapy. Also, there was no significant correlation between the dose given and the percent change in the QT(c). No post-treatment QT(c) exceeded 440 ms. CONCLUSIONS: To our knowledge, this is the first systematic evaluation of the cardiac effects of aripiprazole in children and adolescents. The results are consistent with previously published literature in adults that aripiprazole has no significant cardiac effects and can be deemed a low risk for causing sudden death. It will be important to confirm these findings in a randomized controlled trial. SN - 1557-8992 UR - https://www.unboundmedicine.com/medline/citation/22849533/The_effects_of_aripiprazole_on_electrocardiography_in_children_with_pervasive_developmental_disorders_ L2 - https://www.liebertpub.com/doi/10.1089/cap.2011.0129?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -