Analysis of Electrocardiographic Data Following Use of Paroxetine in Pediatric Depression and Obsessive-Compulsive Disorder

Autor/inn/en	Krulewicz, Stan; Carpenter, David J.; Fong, Regan; Horrigan, Joseph P.; Lipschitz, Alan; Perera, Philip; Wagner, Karen Dineen
Titel	Analysis of Electrocardiographic Data Following Use of Paroxetine in Pediatric Depression and Obsessive-Compulsive Disorder
Quelle	In: Journal of the American Academy of Child and Adolescent Psychiatry, 45 (2006) 4, S.422-430 (9 Seiten) PDF als Volltext Verfügbarkeit
Sprache	englisch
Dokumenttyp	gedruckt; online; Zeitschriftenaufsatz
ISSN	0890-8567
Schlagwörter	Foreign Countries; Patients; Metabolism; Intervals; Pediatrics; Depression (Psychology); Drug Therapy; Diagnostic Tests; Screening Tests; Children; Canada; United States + Suchen Sie Ihr Suchwort? Ausland; Patient; Stoffwechsel; Klinische Sozialpädiatrie; Diagnostic test; Diagnostischer Test; Screening-Verfahren; Child; Kind; Kinder; Kanada; USA
Abstract	Objective: This retrospective analysis of electrocardiographic (ECG) data investigated the cardiovascular effects of paroxetine 10-50 mg/day in pediatric patients (7-18 years of age). Data were collected from three 8- to 10-week, randomized, placebo-controlled, double-blind trials of paroxetine in pediatric patients with major depressive disorder or obsessive-compulsive disorder. Method: Electrocardiograms (ECGs) were retrospectively retrieved from 63 study sites in the United States and Canada. Only patients with at least one screening and one on-treatment ECG were included. ECGs were analyzed for heart rate, QT interval corrected using Bazett's formula (QTcB) and Fridericia's formula (QTcF), at screening and while being treated. PR, R-R, and QRS intervals and the maximum change in QTcB and QTcF from screening to endpoint were determined. Clinically significant thresholds were defined a priori. Results: A total of 1,451 ECGs from 449 patients receiving placebo (n = 207), paroxetine (n = 200), or imipramine (n = 42) were analyzed. Treatment with paroxetine did not significantly increase QTcB or QTcF or any ECG parameters compared with placebo. Treatment with imipramine significantly increased heart rate and QTcB, R-R, and QRS intervals compared with either paroxetine or placebo. Conclusions: Data from this retrospective study indicate that paroxetine (10-50 mg/day) is unlikely to be associated with significant ECG changes in medically healthy pediatric patients. (Contains 4 tables.) (Author).
Anmerkungen	Lippincott Williams & Wilkins. P.O. Box 1600, Hagerstown, MD 21741. Tel: 800-638-3030; Tel: 301-223-2300; Fax: 301-223-2400; Web site: http://www.lww.com/product/?0890-8567
Erfasst von	ERIC (Education Resources Information Center), Washington, DC
Update	2017/4/10