Dabigatran Etexilate: A Review in Pediatric Venous Thromboembolism

<p><strong>Declarations</strong></p> <p><strong>Funding</strong> The preparation of this review was not supported by any external funding.</p> <p><strong>Authorship and Conflict of interest</strong> Julia Paik is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.</p> <p><strong>Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability</strong> not applicable</p> <p>Additional information about this Adis Drug Review can be found _{<a href="http://www.springer.com/gp/adis/products-services/adis-journals-newsletters/adis-drug-reviews" target="_blank">here</a>}</p> <p>Abstract</p> <p>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 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.</p> <p>© Springer Nature Switzerland AG 2022</p>