BRANDAO, L. R., M. ALBISETTI, J. HALTON, L. BOMGAARS, E. CHALMERS, L. G. MITCHELL, I. NURMEEV, P. SVIRIN, Tomáš KUHN, Ondřej ZAPLETAL, I. TARTAKOVSKY, M. SIMETZBERGER, F. L. HUANG, Z. C. SUN, J. KREUZER, S. GROPPER, M. BRUECKMANN and M. LUCIANI. Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. Blood. Washington DC: American Society of Hematology, 2020, vol. 135, No 7, p. 491-504. ISSN 0006-4971. Available from: https://dx.doi.org/10.1182/blood.2019000998.
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Basic information
Original name Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children
Authors BRANDAO, L. R. (124 Canada), M. ALBISETTI (756 Switzerland), J. HALTON (124 Canada), L. BOMGAARS (840 United States of America), E. CHALMERS (826 United Kingdom of Great Britain and Northern Ireland), L. G. MITCHELL (124 Canada), I. NURMEEV, P. SVIRIN (643 Russian Federation), Tomáš KUHN (203 Czech Republic), Ondřej ZAPLETAL (203 Czech Republic, belonging to the institution), I. TARTAKOVSKY (276 Germany), M. SIMETZBERGER (40 Austria), F. L. HUANG (840 United States of America), Z. C. SUN (840 United States of America), J. KREUZER (276 Germany), S. GROPPER (276 Germany), M. BRUECKMANN (276 Germany) and M. LUCIANI (380 Italy, guarantor).
Edition Blood, Washington DC, American Society of Hematology, 2020, 0006-4971.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30205 Hematology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 22.113
RIV identification code RIV/00216224:14110/20:00116026
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1182/blood.2019000998
UT WoS 000522643100005
Keywords in English DEEP-VEIN THROMBOSIS; RISK THROMBOPHILIA STATUS; POSTTHROMBOTIC SYNDROME; CLINICAL-TRIALS; ANTITHROMBOTIC THERAPY; MULTICENTER; WARFARIN; PHARMACOKINETICS; EFFICACY; VTE
Tags 14110317, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 14/7/2021 07:02.
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 >= 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).
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