Header

UZH-Logo

Maintenance Infos

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


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).

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).

Statistics

Citations

Dimensions.ai Metrics

Altmetrics

Downloads

10 downloads since deposited on 16 Jan 2020
10 downloads since 12 months
Detailed statistics

Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Children's Hospital Zurich > Medical Clinic
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Life Sciences > Biochemistry
Life Sciences > Immunology
Health Sciences > Hematology
Life Sciences > Cell Biology
Uncontrolled Keywords:Immunology, Cell Biology, Biochemistry, Hematology
Language:English
Date:13 February 2020
Deposited On:16 Jan 2020 07:06
Last Modified:01 Jan 2021 19:15
Publisher:American Society of Hematology
ISSN:0006-4971
OA Status:Hybrid
Free access at:PubMed ID. An embargo period may apply.
Publisher DOI:https://doi.org/10.1182/blood.2019000998
PubMed ID:31805182

Download

Hybrid Open Access

Download PDF  'Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children'.
Preview
Content: Accepted Version
Filetype: PDF
Size: 2MB
View at publisher