Analysis of Electrocardiographic Data Following Use of Paroxetine in Pediatric Depression and Obsessive-Compulsive Disorder
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| Title: | Analysis of Electrocardiographic Data Following Use of Paroxetine in Pediatric Depression and Obsessive-Compulsive Disorder |
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| Language: | English |
| Authors: | Krulewicz, Stan, Carpenter, David J., Fong, Regan, Horrigan, Joseph P., Lipschitz, Alan, Perera, Philip, Wagner, Karen Dineen |
| Source: | Journal of the American Academy of Child and Adolescent Psychiatry. Apr 2006 45(4):422-430. |
| Availability: | 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 |
| Peer Reviewed: | Y |
| Page Count: | 9 |
| Publication Date: | 2006 |
| Document Type: | Journal Articles Reports - Research |
| Descriptors: | Foreign Countries, Patients, Metabolism, Intervals, Pediatrics, Depression (Psychology), Drug Therapy, Diagnostic Tests, Screening Tests, Children |
| Geographic Terms: | Canada, United States |
| ISSN: | 0890-8567 |
| 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.) |
| Abstractor: | Author |
| Number of References: | 29 |
| Entry Date: | 2007 |
| Access URL: | https://www.lww.com/product/?0890-8567 |
| Accession Number: | EJ754400 |
| Database: | ERIC |
| 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.) |
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| ISSN: | 0890-8567 |
