Key result
A literature review of 13 clinical trials found that phase III studies support the use of rivaroxaban and dabigatran for the prophylaxis and treatment of thrombotic events in children.
Why the study?
Do DOACs (dabigatran and rivaroxaban) effectively treat and prevent thrombotic events in neonates, children, and adolescents?
Do DOACs (dabigatran and rivaroxaban) effectively treat and prevent thrombotic events in neonates, children, and adolescents?
Recent phase III trials support the use of rivaroxaban and dabigatran for treating and preventing thrombosis in pediatric patients.
Supports rivaroxaban and dabigatran for pediatric thrombosis; extends adult phase III data to children.
Thrombotic events are an increasing challenge in pediatrics. Standard-of-care anticoagulants for pediatric thrombosis have several disadvantages which could be overcome by using direct oral anticoagulants (DOACs). Until recently, there was not enough evidence from clinical trials to recommend for or against the use of any of the four DOACs in children with thrombosis. In this literature review, we looked at the latest clinical trials in this field. On clinicaltrials.gov, we found 13 current studies with published results. For two of the four DOACs, namely dabigatran and rivaroxaban, we found successful phase III studies which led to the approval for the use in children. The results of these pivotal phase III studies allow to finally recommend rivaroxaban and dabigatran for the prophylaxis and treatment of thrombotic events in children.
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Halimeh et al. (2022) conducted a review in pediatric thrombosis. Direct oral anticoagulants (DOACs) vs. Standard-of-care anticoagulants was evaluated. A literature review of 13 clinical trials found that phase III studies support the use of rivaroxaban and dabigatran for the prophylaxis and treatment of thrombotic events in children.
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