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Blood. 2019 Dec 5. pii: blood.2019000998. doi: 10.1182/blood.2019000998. [Epub ahead of print]

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

Author information

1
The Hospital for Sick Children, Toronto, District of Columbia, Canada.
2
University Children's Hospital, Zürich, Switzerland.
3
University of Ottawa, Ottawa, Ontario, Canada.
4
Texas Children's Cancer Center, Houston, Texas, United States.
5
Royal Hospital for Sick Children, Glasgow, Glasgow, United Kingdom.
6
University of Alberta, Edmonton, Alberta, Canada.
7
Pediatric Hospital, Kazan, Republic of Tatarstan, Russian Federation.
8
Municipal Children's Hospital 'Morozovskaya', Moscow, Russian Federation.
9
University Hospital Ostrava and Faculty of Medicine University of Ostrava, Ostrava, Czech Republic.
10
University Hospital and Masaryk University Brno, Brno, Czech Republic.
11
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
12
Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria.
13
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, United States.
14
Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Alabama, United States.
15
Boehringer Ingelheim Singapore Pte. Ltd, Singapore, Singapore.
16
Pediatric Hospital Bambino Gesù, Rome, Italy.

Abstract

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).

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