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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F20%3AA2102940" target="_blank" >RIV/61988987:17110/20:A2102940 - isvavai.cz</a>

Alternative codes found

RIV/00216224:14110/20:00116026 RIV/65269705:_____/20:00072665 RIV/00843989:_____/20:E0108389 RIV/00064203:_____/20:10412680

Result on the web

<a href="https://watermark.silverchair.com/bloodbld2019000998.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA8UwggPBBgkqhkiG9w0BBwagggOyMIIDrgIBADCCA6cGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMZD0RPuAbrKSWgwAdAgEQgIIDeOb4wxLbO_zM6MIH9Z5f3tpX6pzgMkAtmd1" target="_blank" >https://watermark.silverchair.com/bloodbld2019000998.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA8UwggPBBgkqhkiG9w0BBwagggOyMIIDrgIBADCCA6cGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMZD0RPuAbrKSWgwAdAgEQgIIDeOb4wxLbO_zM6MIH9Z5f3tpX6pzgMkAtmd1</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1182/blood.2019000998" target="_blank" >10.1182/blood.2019000998</a>

Result language

angličtina

Original language name

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

Original language description

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. (Blood. 2020;135(7):491-504) © 2020 by The American Society of Hematology

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30205 - Hematology

Project

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Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2020

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Blood

ISSN

0006-4971

e-ISSN

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Volume of the periodical

135

Issue of the periodical within the volume

7

Country of publishing house

US - UNITED STATES

Number of pages

14

Pages from-to

491-504

UT code for WoS article

000522643100005

EID of the result in the Scopus database

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