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

LR Brandão, M Albisetti, J Halton… - Blood, The Journal …, 2020 - ashpublications.org
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 …

Safety, tolerability and clinical pharmacology of dabigatran etexilate in adolescents

JML Halton, T Lehr, L Cronin… - Thrombosis and …, 2016 - thieme-connect.com
Venous thromboembolism (VTE) incidence is increasing among children owing to many
factors, including improved diagnosis of VTE. There is a need for alternative treatment …

[HTML][HTML] Phase IIa study of dabigatran etexilate in children with venous thrombosis: pharmacokinetics, safety, and tolerability

JML Halton, M Albisetti, B Biss, L Bomgaars… - Journal of Thrombosis …, 2017 - Elsevier
Essentials• Dabigatran etexilate may provide a new treatment option for pediatric venous
thromboembolism.• Children aged 1 to< 12 years were given dabigatran etexilate in an …

Dabigatran etexilate for the treatment of acute venous thromboembolism in children (DIVERSITY): a randomised, controlled, open-label, phase 2b/3, non-inferiority …

J Halton, LR Brandão, M Luciani, L Bomgaars… - The Lancet …, 2021 - thelancet.com
Background Dabigatran etexilate is a direct oral anticoagulant with potential to overcome the
limitations of standard of care in children with venous thromboembolism. The aims of this …

Extended use of dabigatran, warfarin, or placebo in venous thromboembolism

S Schulman, C Kearon, AK Kakkar… - … England Journal of …, 2013 - Mass Medical Soc
Background Dabigatran, which is administered in a fixed dose and does not require
laboratory monitoring, may be suitable for extended treatment of venous thromboembolism …

[HTML][HTML] Assessing the anticoagulant effect of dabigatran in children: an in vitro study

K Dietrich, L Stang, J van Ryn, LG Mitchell - Thrombosis Research, 2015 - Elsevier
Objectives Age-related changes in the hemostatic system result in variation in response to
anticoagulants and coagulation assays over childhood. This study used in vitro methods to …

Current clinical trials on the use of direct oral anticoagulants in the pediatric population

E von Vajna, R Alam, TY So - Cardiology and Therapy, 2016 - Springer
Common treatment options for deep vein thrombosis and venous thromboembolism in the
pediatric population include unfractionated heparin, low molecular weight heparin, and …

Dabigatran etexilate in clinical practice: confronting challenges to improve safety and effectiveness

MP Gulseth, AK Wittkowsky, J Fanikos… - … : The Journal of …, 2011 - Wiley Online Library
A number of novel anticoagulants are moving through various stages of drug development.
Recently, the United States Food and Drug Administration approved the oral direct thrombin …

[PDF][PDF] Efficacy and safety of dabigatran in a" real-life" population at high thromboembolic and hemorrhagic risk: data from MonaldiCare registry.

V Russo, V Bianchi, C Cavallaro… - European Review for …, 2015 - researchgate.net
OBJECTIVE: Dabigatran is a nov-el target specific oral anticoagulant for stroke prevention in
non valvular atrial fibrillation. Little is still known about its real-world effectiveness and safety …

Pharmacokinetics and pharmacodynamics of anticoagulants in paediatric patients

DL Yee, SH O'Brien, G Young - Clinical pharmacokinetics, 2013 - Springer
Given the rising incidence of thrombotic complications in paediatric patients, understanding
of the pharmacologic behaviour of anticoagulant drugs in children has gained importance …