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

J 2020

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

BRANDAO, L. R., M. ALBISETTI, J. HALTON, L. BOMGAARS, E. CHALMERS et. al.

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

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

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

Abstract

V originále

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).

Citovat

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.

@article{1670612,
   author = {Brandao, L. R. and Albisetti, M. and Halton, J. and Bomgaars, L. and Chalmers, E. and Mitchell, L. G. and Nurmeev, I. and Svirin, P. and Kuhn, Tomáš and Zapletal, Ondřej and Tartakovsky, I. and Simetzberger, M. and Huang, F. L. and Sun, Z. C. and Kreuzer, J. and Gropper, S. and Brueckmann, M. and Luciani, M.},
   article_location = {Washington DC},
   article_number = {7},
   doi = {http://dx.doi.org/10.1182/blood.2019000998},
   keywords = {DEEP-VEIN THROMBOSIS; RISK THROMBOPHILIA STATUS; POSTTHROMBOTIC SYNDROME; CLINICAL-TRIALS; ANTITHROMBOTIC THERAPY; MULTICENTER; WARFARIN; PHARMACOKINETICS; EFFICACY; VTE},
   language = {eng},
   issn = {0006-4971},
   journal = {Blood},
   title = {Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children},
   url = {https://watermark.silverchair.com/bloodbld2019000998.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA-cwggPjBgkqhkiG9w0BBwagggPUMIID0AIBADCCA8kGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMw-3e0CJJawRicbJVAgEQgIIDmsR14TKvPR0YxTM32ezJHDLRAtNrsy-0VtZ},
   volume = {135},
   year = {2020}
}

TY  - JOUR
ID  - 1670612
AU  - Brandao, L. R. - Albisetti, M. - Halton, J. - Bomgaars, L. - Chalmers, E. - Mitchell, L. G. - Nurmeev, I. - Svirin, P. - Kuhn, Tomáš - Zapletal, Ondřej - Tartakovsky, I. - Simetzberger, M. - Huang, F. L. - Sun, Z. C. - Kreuzer, J. - Gropper, S. - Brueckmann, M. - Luciani, M.
PY  - 2020
TI  - Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children
JF  - Blood
VL  - 135
IS  - 7
SP  - 491-504
EP  - 491-504
PB  - American Society of Hematology
SN  - 00064971
KW  - DEEP-VEIN THROMBOSIS
KW  - RISK THROMBOPHILIA STATUS
KW  - POSTTHROMBOTIC SYNDROME
KW  - CLINICAL-TRIALS
KW  - ANTITHROMBOTIC THERAPY
KW  - MULTICENTER
KW  - WARFARIN
KW  - PHARMACOKINETICS
KW  - EFFICACY
KW  - VTE
UR  - https://watermark.silverchair.com/bloodbld2019000998.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA-cwggPjBgkqhkiG9w0BBwagggPUMIID0AIBADCCA8kGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMw-3e0CJJawRicbJVAgEQgIIDmsR14TKvPR0YxTM32ezJHDLRAtNrsy-0VtZ
L2  - https://watermark.silverchair.com/bloodbld2019000998.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA-cwggPjBgkqhkiG9w0BBwagggPUMIID0AIBADCCA8kGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMw-3e0CJJawRicbJVAgEQgIIDmsR14TKvPR0YxTM32ezJHDLRAtNrsy-0VtZ
N2  - 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).
ER  -

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. \textit{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.

Detailed Information on Publication Record