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Safety of levocetirizine treatment in young atopic children: An 18-month study

Authors

  • F. Estelle R. Simons,

    1. Departments of Pediatrics and Child Health, and Immunology, Canadian Institutes of Health Research National Training Program in Allergy and Asthma, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
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  • on Behalf of the Early Prevention of Asthma in Atopic Children (EPAAC) Study Group*

    1. Departments of Pediatrics and Child Health, and Immunology, Canadian Institutes of Health Research National Training Program in Allergy and Asthma, Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
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  • *

    See Appendix.

F. Estelle .R. Simons, 820 Sherbrook Street, Winnipeg, Manitoba R3A 1R9 Canada
Tel.: +1 204 787 2537
Fax: +1 204 787 5040
E-mail: lmcniven@hsc.mb.ca

Abstract

There are more than 40 H1-antihistamines available worldwide. Most of these medications have never been optimally studied in prospective, randomized, double-masked, placebo-controlled trials in children. The aim was to perform a long-term study of levocetirizine safety in young atopic children. In the randomized, double-masked Early Prevention of Asthma in Atopic Children Study, 510 atopic children who were age 12–24 months at entry received either levocetirizine 0.125 mg/kg or placebo twice daily for 18 months. Safety was assessed by: reporting of adverse events, numbers of children discontinuing the study because of adverse events, height and body mass measurements, assessment of developmental milestones, and hematology and biochemistry tests. The population evaluated for safety consisted of 255 children given levocetirizine and 255 children given placebo. The treatment groups were similar demographically, and with regard to number of children with: one or more adverse events (levocetirizine, 96.9%; placebo, 95.7%); serious adverse events (levocetirizine, 12.2%; placebo, 14.5%); medication-attributed adverse events (levocetirizine, 5.1%; placebo, 6.3%); and adverse events that led to permanent discontinuation of study medication (levocetirizine, 2.0%; placebo, 1.2%). The most frequent adverse events related to: upper respiratory tract infections, transient gastroenteritis symptoms, or exacerbations of allergic diseases. There were no significant differences between the treatment groups in height, mass, attainment of developmental milestones, and hematology and biochemistry tests. The long-term safety of levocetirizine has been confirmed in young atopic children.

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