Dabigatran Etexilate: A Review in Pediatric Venous Thromboembolism.

Julia Paik

Paediatric drugs 2022 Jul

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Although rare in children, venous thromboembolism (VTE) is markedly more likely in hospitalized patients, particularly with the use of central venous access devices. Dabigatran etexilate (Pradaxa®) is one of the first direct non-vitamin K antagonist oral anticoagulants (DOAC) approved for use in pediatric patients. It is approved in the EU and USA for the treatment of VTE in patients who have been treated with a parenteral anticoagulant for ≥ 5 days, and for the prevention of recurrent VTE. In an open-label, phase 2b/3 clinical trial in pediatric patients with acute VTE treated for ≈ 3 months, dabigatran etexilate was non-inferior to standard of care (SOC) treatment for the primary composite endpoint of complete thrombus resolution, freedom from recurrent VTE and VTE-related death. In a single-arm phase 3 safety study, few patients experienced recurrent VTE with ≤ 12 months of anticoagulation with dabigatran etexilate. Dabigatran etexilate was generally well tolerated in both studies; bleeding events were mostly minor and, in the phase 2b/3 study, occurred at a similar incidence to SOC. Although further data will be useful, dabigatran etexilate is a valuable and convenient treatment option in pediatric VTE. © 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.