Original article
Safety and Efficacy of Clopidogrel in Children with Heart Disease

https://doi.org/10.1016/j.jpeds.2007.12.050Get rights and content

Objective

To evaluate the efficiency and safety of clopidogrel treatment in children with heart disease.

Study design

We conducted single center retrospective chart review of children with heart disease at the University Hospital, Leuven, Belgium, in whom clopidogrel was used. The indication, dosage, duration of therapy, and adverse events were examined. Clinical efficacy was defined by an absence of thrombotic events.

Results

46 children were identified. The mean age of first clopidogrel dose was 4.9 ± 4.1 years. The study dosage ranged from 0.1 to 0.7 mg/kg/day clopidogrel. Almost all patients received concomitant aspirin therapy. No thrombotic events developed. Skin bruising developed in almost every patient, suggesting that clopidogrel has an anti-platelet effect. 2 patients who were treated with concomitant warfarin had bleeding complications (severe epistaxis and gastrointestinal bleeding). Hematological abnormalities were documented in 1 patient who received clopidogrel for 1 year; they reversed with medication cessation.

Conclusion

Clopidogrel therapy in a pediatric population appears to be relatively safe and effective; however, randomized, controlled prospective studies are needed to determine the true efficacy and safety of clopidogrel in children.

Section snippets

Methods

The data gathered for this analysis is retrospective. This report has been prepared in accordance with the ICH Harmonized Tripartite Guideline on the Structure and Content of Clinical Study Reports, dated July 1996. Patient confidentiality was ensured by using patient initials on the case report form in lieu of the patient's name.

Patients in the study were selected when they had received clopidogrel in our cardiology unit since 2000, and the parent or guardian of the child had given prior

Results

46 children (29 male, 17 female) were included in this study. Most patients were Caucasian (n = 45); 1 patient was of unknown race/ethnicity. The mean age at the first dose was 4.9 ± 4.1 years (median age, 3.9 years; age range, 7 days-15 years). The mean weight at first administration of the drug was 19.0 ± 14.9 kg (median weight, 15 kg; weight range, 3.6-72 kg). Most patients (44/46) were treated because of congenital heart disease: 36 patients had a functionally univentricular heart, 3

Discussion

We report on the use of clopidogrel (for a mean duration of 3 months) in 46 children at a relatively low dose (initially 0.5-1.0 mg/kg/day, then 0.2-0.3 mg/kg/day), and another study used considerably higher doses (1-6 mg/kg/day).9 Additionally, almost all patients in our study received concomitant ASA. Our study indicates that clopidogrel should be used cautiously in children, and that adult dosing of clopidogrel cannot be extrapolated to children on the basis of physiologic and metabolic

References (15)

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The data collection for this study was financially supported by Bristol-Myers Squibb and sanofi-aventis. The sponsor provided financial support for the data collection. The authors are responsible for the study design, the data collection, analysis, writing of the report, and the decision to submit the paper for publication. No money was received for writing the report.

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