Absence of QTcProlongation with Cetirizine in Children Aged 6 to 11 Years

Abstract

In previous clinical trials, cetirizine has been shown to be efficacious in the treatment of seasonal allergic rhinitis (SAR), perennial allergic rhinitis, and chronic idiopathic urticaria when given once daily. As significant QT prolongation and cardiac arrhythmias have been reported with some of the newer antihistamines, the electrocardiographic effects of cetirizine were evaluated. A previous study in normal, healthy, adult volunteers had demonstrated that cetirizine does not prolong the QT interval at up to six times the maximum clinical dose. The intent of this study was to evaluate the electrocardiographic effects of cetirizine in children. As part of a randomized, 4-week, controlled clinical trial, electrocardiograms (ECGs) were obtained for 119 children aged 6 to 11 years with SAR. Participants in this trial received either a placebo (N = 40), 10 mg of cetirizine (N = 44), or 5 mg of cetirizine (N = 35). The QT interval was measured on a 12-lead ECG at the baseline visit (day 1) and at visit 2 (days 11-17). The QT interval was determined by a digitizing method and corrected for heart rate by the Hodges' formula for corrected QT interval (QTc). Five and 10 mg of cetirizine did not result in changes in the QTc interval that were significantly different statistically from those of a placebo. Furthermore, the number of patients with a 10% to 20% increase in QTc interval was comparable across all treatment groups. Finally, no patients had a QTc interval increase of greater than 20% from baseline. The study demonstrates that cetirizine, up to 10 mg once daily, did not prolong the QTc interval in pediatric patients with SAR.