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Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children
LR. Brandão, M. Albisetti, J. Halton, L. Bomgaars, E. Chalmers, LG. Mitchell, I. Nurmeev, P. Svirin, T. Kuhn, O. Zapletal, I. Tartakovsky, M. Simetzberger, F. Huang, Z. Sun, J. Kreuzer, S. Gropper, M. Brueckmann, M. Luciani, DIVERSITY Study Investigators,
Language English Country United States
Document type Clinical Trial, Phase III, Journal Article, Research Support, Non-U.S. Gov't
NLK
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from 1946 to 1 year ago
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- MeSH
- Time Factors MeSH
- Dabigatran adverse effects pharmacokinetics therapeutic use MeSH
- Child MeSH
- Kaplan-Meier Estimate MeSH
- Infant MeSH
- Humans MeSH
- Adolescent MeSH
- Follow-Up Studies MeSH
- Child, Preschool MeSH
- Risk Factors MeSH
- Secondary Prevention * MeSH
- Endpoint Determination MeSH
- Venous Thromboembolism drug therapy prevention & control MeSH
- Check Tag
- Child MeSH
- Infant MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
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 ≥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 end points included VTE recurrence, bleeding events, and mortality at 6 and 12 months. Overall, 203 children received dabigatran, with median exposure being 36.3 weeks (range, 0-57 weeks); 171 of 203 (84.2%) and 32 of 203 (15.8%) took capsules and pellets, respectively. Overall, 2 of 203 children (1.0%) experienced on-treatment VTE recurrence, and 3 of 203 (1.5%) experienced major bleeding events, with 2 (1.0%) reporting clinically relevant nonmajor bleeding events, and 37 (18.2%) minor bleeding events. There were no on-treatment deaths. On-treatment postthrombotic syndrome was reported for 2 of 162 children (1.2%) 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). This trial was registered at www.clinicaltrials.gov as #NCT02197416.
Biostatistics and Data Sciences Boehringer Ingelheim Pharmaceuticals Inc Ridgefield CT
Boehringer Ingelheim Singapore Pte Ltd Singapore
Children's Hospital of Eastern Ontario University of Ottawa Ottawa ON Canada
Department of Clinical Development Boehringer Ingelheim RCV GmbH and Co KG Vienna Austria
Department of Pediatrics University of Alberta Edmonton AB Canada
Hematology Department University Children's Hospital Zürich Switzerland
Pediatric Hematology Department Municipal Children's Hospital Morozovskaya Moscow Russian Federation
Pediatric Hematology Oncology Department Pediatric Hospital Bambino Gesù Rome Italy
Pediatric Hospital Republic of Tatarstan Kazan Medical University Kazan Russian Federation
Royal Hospital for Children Glasgow Scotland United Kingdom
References provided by Crossref.org
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