Dabigatran Etexilate: A Review in Pediatric Venous Thromboembolism

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.Venous thromboembolism (VTE) is rare in children, but its risk is markedly increased in hospitalized patients. Oral dabigatran etexilate (Pradaxa®) is one of the first of its class to be approved to treat acute VTE and for the secondary prevention of VTE in pediatric patients. In clinical trials conducted in children (aged < 18 years), dabigatran etexilate had similar efficacy to standard of care treatments (other anticoagulants) in acute VTE, and prevented recurrent VTE with longer-term anticoagulation. Dabigatran etexilate was generally well tolerated; most bleeding events during treatment were minor. Although further data will be useful, dabigatran etexilate is a valuable and convenient treatment option in pediatric VTE.