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.

Základní údaje

Originální název

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

Autoři

BRANDAO, L. R. (124 Kanada), M. ALBISETTI (756 Švýcarsko), J. HALTON (124 Kanada), L. BOMGAARS (840 Spojené státy), E. CHALMERS (826 Velká Británie a Severní Irsko), L. G. MITCHELL (124 Kanada), I. NURMEEV, P. SVIRIN (643 Rusko), Tomáš KUHN (203 Česká republika), Ondřej ZAPLETAL (203 Česká republika, domácí), I. TARTAKOVSKY (276 Německo), M. SIMETZBERGER (40 Rakousko), F. L. HUANG (840 Spojené státy), Z. C. SUN (840 Spojené státy), J. KREUZER (276 Německo), S. GROPPER (276 Německo), M. BRUECKMANN (276 Německo) a M. LUCIANI (380 Itálie, garant)

Vydání

Blood, Washington DC, American Society of Hematology, 2020, 0006-4971

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30205 Hematology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 22.113

Kód RIV

RIV/00216224:14110/20:00116026

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1182/blood.2019000998

UT WoS

000522643100005

Klíčová slova anglicky

DEEP-VEIN THROMBOSIS; RISK THROMBOPHILIA STATUS; POSTTHROMBOTIC SYNDROME; CLINICAL-TRIALS; ANTITHROMBOTIC THERAPY; MULTICENTER; WARFARIN; PHARMACOKINETICS; EFFICACY; VTE

Štítky

14110317, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 14. 7. 2021 07:02, Mgr. Tereza Miškechová

Anotace

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 a M. LUCIANI. Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. Blood. Washington DC: American Society of Hematology, 2020, roč. 135, č. 7, s. 491-504. ISSN 0006-4971. Dostupné z: 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 a M. LUCIANI. Safety of dabigatran etexilate for the secondary prevention of venous thromboembolism in children. \textit{Blood}. Washington DC: American Society of Hematology, 2020, roč.~135, č.~7, s.~491-504. ISSN~0006-4971. Dostupné z: https://dx.doi.org/10.1182/blood.2019000998.

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