Just DOAC: Use of direct-acting oral anticoagulants in pediatrics

Am J Health Syst Pharm. 2023 Mar 21;80(7):412-422. doi: 10.1093/ajhp/zxac387.

Abstract

Purpose: The aim of this article is to provide an overview of the current literature for direct-acting oral anticoagulant (DOAC) use in pediatric patients and summarize ongoing trials.

Summary: In treatment of venous thromboembolism (VTE) in pediatric patients, evidence supports use of both dabigatran and rivaroxaban. Dabigatran has been shown to be noninferior to standard of care (SOC) in terms of efficacy, with similar bleeding rates. Similarly, treatment with rivaroxaban in children with acute VTE resulted in a low recurrence risk and reduced thrombotic burden, without increased risk of bleeding, compared to SOC. Treatment of pediatric cerebral venous thrombosis as well as central venous catheter-related VTE with rivaroxaban appeared to be both safe and efficacious and similar to that with SOC. Dabigatran also has a favorable safety profile for prevention of VTE, and rivaroxaban has a favorable safety profile for VTE prevention in children with congenital heart disease. Many studies with several different DOACs are ongoing to evaluate both safety and efficacy in unique patient populations, as well as VTE prevention.

Conclusion: The literature regarding pediatric VTE treatment and prophylaxis is growing, but the need for evidence-based pediatric guidelines remains. Additional long-term, postauthorization studies are warranted to further elucidate safety and efficacy in clinical scenarios excluded in clinical trials. Additional data on safety, efficacy, and dosing strategies for reversal agents are also necessary, especially as the use of DOACs becomes more common in the pediatric population.

Keywords: anticoagulants; pediatrics; thromboembolism; thrombosis.

MeSH terms

  • Administration, Oral
  • Anticoagulants / adverse effects
  • Child
  • Dabigatran / adverse effects
  • Factor Xa Inhibitors / adverse effects
  • Hemorrhage / chemically induced
  • Humans
  • Rivaroxaban* / adverse effects
  • Venous Thromboembolism* / drug therapy
  • Venous Thromboembolism* / prevention & control

Substances

  • Rivaroxaban
  • Anticoagulants
  • Factor Xa Inhibitors
  • Dabigatran