Medications approved for adults often have additional uses in pediatric patients. Such is the case — as described by Wessel and colleagues — for clopidogrel, an agent that blocks the P2Y12 component of adenosine diphosphate (ADP) receptors on the surface of platelets. ADP receptors prevent the activation of the glycoprotein IIb/IIIa receptor complex, thereby reducing aggregation. Clopidogrel is used most commonly as a prophylactic antiplatelet therapy in adults with atherosclerotic cardiovascular disease, but is increasingly employed in the pediatric population, particularly in those with cardiac disease. Pediatric cardiovascular practitioners are using clopidogrel (along with the standard aspirin) to prevent the thrombosis of systemic-to-pulmonary-artery shunts in patients with complex cyanotic heart disease; however, the safety and efficacy of this practice have never been looked at prospectively. In the June 20 issue of The New England Journal of Medicine, investigators created a multicenter, event-driven trial to evaluate clopidogrel’s effect on infants.
A total of 906 subjects were enrolled, 467 in the clopidogrel group and 439 in the placebo group. The authors found that adding clopidogrel to conventional therapies (i.e., aspirin) did not affect mortality from any cause or shunt-thrombosis-related morbidity. Although no statistically significant differences were detected in total subjects with adverse events, the authors found more neurologic events in the clopidogrel group versus the placebo group. Read the full Concise Critical Appraisal.