Original articleSafety and Efficacy of Clopidogrel in Children with Heart Disease
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
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2013, International Journal of CardiologyCitation Excerpt :As many as 25% of clinical thromboembolic events in patients with Fontan surgery are fatal [16,18]. While the prevention of thromboembolic events is a desirable clinical goal, controversy exists as to the optimal prophylaxis strategy [16,18–25]. Given the paucity of evidence regarding prophylactic therapy with newer antithrombotic regimens in this patient population [24], aspirin (ASA) or warfarin remain the mainstay of antiplatelet or anticoagulant therapy.
Efficacy and safety of clopidogrel in children with diarrhea associated hemolytic uremic syndrome
2012, Thrombosis ResearchCitation Excerpt :Fear of bleeding may limit use of PAI in children with HUS [4]. The incidence of significant bleeding events in children treated with clopidogrel for cardiac and neurologic indications varies from 0-12%; in all cases, children were receiving multiple anti-thrombotic agents [15–18]. Fear of bleeding may be heightened in patients with HUS due to thrombocytopenia.
Antithrombotic therapy in neonates and children: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines
2012, ChestCitation Excerpt :High rates of excessive skin bruising have been reported when clopidogrel is used in combination with aspirin, and major bleeding is reported in children receiving concomitant warfarin therapy.207 Other studies have reported lower rates, but all studies to date have been small and retrospective.208 Overdose has been reported with minimal adverse effects.209
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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.