Key result
Direct-acting oral anticoagulants (dabigatran and rivaroxaban) appear safe and efficacious compared to standard of care for treating and preventing venous thromboembolism in pediatric patients.
Why the study?
To provide an overview of current literature regarding direct-acting oral anticoagulant use in pediatric patients and summarize ongoing trials.
Are direct-acting oral anticoagulants (DOACs) safe and effective compared to standard of care for the treatment and prevention of venous thromboembolism in pediatric patients?
Are direct-acting oral anticoagulants (DOACs) safe and effective compared to standard of care for the treatment and prevention of venous thromboembolism in pediatric patients?
DOACs such as dabigatran and rivaroxaban appear safe and effective for VTE treatment and prophylaxis in pediatric patients, though formal guidelines and long-term data are still needed.
May support DOAC consideration for pediatric VTE; leaves open need for guidelines and long-term prospective data.
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.
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Mills et al. (2023) conducted a review in Venous thromboembolism (VTE). Direct-acting oral anticoagulants (DOACs) vs. Standard of care (SOC) was evaluated. Direct-acting oral anticoagulants (dabigatran and rivaroxaban) appear safe and efficacious compared to standard of care for treating and preventing venous thromboembolism in pediatric patients.
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