Analysis of electrocardiographic data following use of paroxetine in pediatric depression and obsessive-compulsive disorder.
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.


METHODS
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.
Krulewicz
Stan
S
GlaxoSmithKline Pharmaceuticals, King of Prussia, PA 19406-2772, USA. stan.krulewicz@gsk.com
Carpenter
David J
DJ
Fong
Regan
R
Horrigan
Joseph P
JP
Lipschitz
Alan
A
Perera
Philip
P
Wagner
Karen Dineen
KD
D000293:Adolescent; D002170:Canada; D002648:Child; D003866:Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects*; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D017374:Paroxetine / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D014481:United States
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors