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Dabigatran Etexilate: A Review in Pediatric Venous Thromboembolism

Julia Paik1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.

Paediatric Drugs
|June 14, 2022
PubMed

Insights

Dabigatran etexilate is a safe and effective oral anticoagulant for treating pediatric venous thromboembolism (VTE). Studies show it is non-inferior to standard care and well-tolerated, offering a convenient option for children.

Area of Science:

  • Pediatric Hematology
  • Pharmacology
  • Clinical Trials

Background:

  • Venous thromboembolism (VTE) is rare but more common in hospitalized children, especially with central venous access.
  • Direct oral anticoagulants (DOACs) offer new treatment avenues for pediatric VTE.
  • Dabigatran etexilate is approved for VTE treatment and prevention in pediatric patients.

Purpose of the Study:

  • To evaluate the efficacy and safety of dabigatran etexilate in pediatric patients with acute VTE.
  • To compare dabigatran etexilate with standard of care (SOC) for VTE treatment outcomes.
  • To assess the long-term safety and recurrence rates of VTE with dabigatran etexilate.

Main Methods:

  • An open-label, phase 2b/3 clinical trial was conducted for VTE treatment.
  • A single-arm phase 3 study assessed safety and recurrence over 12 months.
  • Primary endpoint included thrombus resolution, freedom from recurrent VTE, and VTE-related death.

Main Results:

  • Dabigatran etexilate demonstrated non-inferiority to SOC for the primary composite endpoint in acute VTE treatment.
  • Recurrent VTE events were infrequent in the phase 3 safety study over 12 months.
  • The drug was generally well-tolerated, with mostly minor bleeding events comparable to SOC.

Conclusions:

  • Dabigatran etexilate is a valuable and convenient treatment option for pediatric VTE.
  • It offers comparable efficacy and safety to standard treatments.
  • Further data will continue to support its role in managing pediatric VTE.

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