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Anticoagulant Effects of Dabigatran in Paediatric Patients Compared with Adults: Combined Data from Three Paediatric

Hugo Maas1, Savion Gropper2, Fenglei Huang3

  • 1Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.

Thrombosis and Haemostasis
|August 17, 2018
PubMed

Insights

Physiological age-related changes minimally impact dabigatran etexilate (DE) anticoagulant assay responses in children versus adults. Further pediatric trials are needed to confirm these findings on coagulation assay results.

Area of Science:

  • Pharmacology
  • Hematology
  • Pediatrics

Background:

  • Physiological changes in hemostasis and coagulation systems affect anticoagulant responses.
  • Investigated age-related differences in anticoagulant assay responses to dabigatran etexilate (DE).

Purpose of the Study:

  • To assess the relationship between plasma dabigatran concentration and coagulation assay results in children and adults.
  • To understand the impact of dabigatran on diluted thrombin time (dTT), ecarin clotting time (ECT), and activated partial thromboplastin time (aPTT) across different age groups.

Main Methods:

  • Compared data from pediatric clinical trials using DE with adult clinical trial data.
  • Analyzed the effects of dabigatran concentration on dTT, ECT, and aPTT using graphical and modeling approaches.

Main Results:

  • Concentration-dTT relationships were consistent between children and adults.
  • ECT and aPTT showed similar ratio-based relationships across ages, but absolute clotting times varied in infants <1 year.
  • Modeling indicated largely comparable concentration-clotting time relationships, with minor shifts in ECT and aPTT for infants <2 months.

Conclusions:

  • Developmental hemostatic changes appear to have minimal impact on dabigatran etexilate response.
  • Further pediatric clinical trials are necessary to validate these findings and assess clinical outcomes.
Abstract

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