Long-term study confirms the safety and effectiveness of rivaroxaban for children

Long-term study confirms the safety and effectiveness of rivaroxaban for children

Venous thromboembolism (VTE) is a life-threatening complication in children with serious underlying medical conditions such as heart defects or cancer. Treating or preventing thrombosis represents an additional challenge in daily clinical practice. A therapy using the active ingredient rivaroxaban, which was specifically tailored to children, was successfully tested for the first time in 2020. Now long-term data confirm the advantages of this drug treatment for expanded use. The study was carried out by an international research team led by Meduni Vienna and published in the journal “The Lancet Hematology”.

The long-term data, led by the research team of Christoph Male from the Department of Pediatrics and Adolescent Medicine at Meduni Vienna, provides the first reliable evidence for extended anticoagulation in children. The study assessed extended treatment in a cohort of around 500 children and adolescents from the EINSTEIN Jr study, whose data on acute phase anticoagulation was already published in 2020. Those study results, also published under the leadership of MedUni Vienna, showed that the anticoagulant rivaroxaban is at least as effective and safe as the standard anticoagulants used to date in children with venous thromboembolism, but also offers a number of advantages for young patients. The positive results paved the way for global approval of rivaroxaban for children in 2021. To date, there has been a lack of research into extended anticoagulation in children with VTE, and with rivaroxaban in particular a gap that has now been filled by recently published long-term study: Research shows that long-term treatment of up to one year with one year with the low is a long-term risk. Rivaroxaban is therefore the first scientifically proven age-appropriate alternative to the standard anticoagulation therapies currently available for children.

Specially adapted to children

Venous thromboembolism (VTE) occurs when blood clots form in deep veins, causing local blockage or embolization of the clot to the lungs - a potentially life-threatening condition. While this condition has been well researched in adults, there has long been a lack of solid data for children. Until recently, treatment with anticoagulant medications relied on the use of off-label drugs originally developed for adults such as heparin or vitamin K antagonists. These medications have some disadvantages that are particularly problematic for children, such as administration by injection and the need for regular blood tests. Direct oral anticoagulants such as rivaroxaban, which have several advantages in practical use, were originally developed for adults as well. However, in recent years they have been adapted specifically for children and tested in clinical trials.

Our Einstein Jr. study and now available long-term research show that rivaroxaban is an effective and safe option for preventing recurrent thrombosis in children, not only during acute treatment but also for extended treatment - providing the first science-based, age-appropriate alternative to existing standard therapies. “

Christoph male, study guide

The drug's importance for anticoagulation in children is also highlighted in an accompanying editorial in Lancet Hematology.

Sources: