Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children

Leonardo R Brandao, Manuela Albisetti, Jacqueline Halton, Lisa Bomgaars, Elizabeth Chalmers, Lesley G Mitchell, Ildar Nurmeev, Pavel Svirin, Tomas Kuhn, Ondrej Zapletal, Igor Tartakovsky, Monika Simetzberger, Fenglei Huang, Zhichao Sun, Jörg Kreuzer, Savion Gropper, Martina Brueckmann, Matteo Luciani

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This open-label, single-arm, prospective cohort trial is the first phase 3 safety study to describe outcomes in children treated with dabigatran etexilate for secondary venous thromboembolism (VTE) prevention. Eligible children aged 12 to <18 years (age stratum 1), 2 to <12 years (stratum 2), and >3 months to <2 years (stratum 3) had an objectively confirmed diagnosis of VTE treated with standard of care (SOC) for {greater than or equal to}3 months, or had completed dabigatran or SOC treatment in the DIVERSITY trial (NCT01895777) and had an unresolved clinical thrombosis risk factor requiring further anticoagulation. Children received dabigatran for up to 12 months, or less if the identified VTE clinical risk factor resolved. Primary endpoints included VTE recurrence, bleeding events, and mortality at 6 and 12 months. Overall, 203 children received dabigatran, with median exposure being 36.3 (range 0-57) weeks; 171/203 (84.2%) and 32/203 (15.8%) took capsules and pellets, respectively. Overall, 2/203 (1.0%) children experienced on-treatment VTE recurrence, and 3/203 (1.5%) experienced major bleeding events, with 2 (1.0%) reporting clinically relevant non-major bleeding events, and 37 (18.2%) minor bleeding events. There were no on-treatment deaths. On-treatment postthrombotic syndrome was reported for 2/162 (1.2%) children who had deep vein thrombosis or central line thrombosis as their most recent VTE. Pharmacokinetic/pharmacodynamic relationships of dabigatran were similar to those in adult VTE patients. In summary, dabigatran showed a favorable safety profile for secondary VTE prevention in children aged from >3 months to <18 years with persistent VTE risk factor(s).

Original languageEnglish
Publication statusE-pub ahead of print - Dec 5 2019


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