In vitro assessment of edoxaban anticoagulant effect in pediatric plasma

Epub ahead of printINTRODUCTION: Anticoagulant therapy in pediatric patients remains an issue and safer therapies, such as direct oral anticoagulants could overcome the limitations of conventional anticoagulant treatments in this population. Edoxaban, a factor Xa inhibitor, is used for the prevention and treatment of venous thromboembolism. Due to its pharmacokinetic characteristics, edoxaban is a promising candidate molecule for children. This study compared edoxaban in vitro effect in children and adults. MATERIALS AND METHODS: Blood samples were prospectively collected from 87 adults and 97 children (n=12: <2year-old; n=8: 2-4year-old; n=9: 5-7year-old; n=14: 8-9year-old; n=10: 10-13year-old; n=15: 14-15year-old; and n=29: 16-18year-old). Plasma samples were supplemented in vitro with edoxaban to a final concentration of 50, 150 or 300ng/mL, and then edoxaban effect on prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen (Clauss assay), specific anti-factor Xa activity and thrombin generation assay (TGA) (with 5pM tissue factor and 4nM phospholipids) was evaluated. RESULTS: PT, aPTT, and specific anti-Xa activity exhibited similar dose-dependent responses to edoxaban in the different age groups. The reduction of thrombin peak, the most edoxaban-sensitive TGA parameter, was similar in adults and children, but for the youngest group (<2year-old) where the peak value reduction (median [Q1-Q3]) was higher than in adults (51% [44-59] versus 40% [32-46], p<0.01; 74% [63-80] versus 65% [58-70], p<0.05; and 84% [73-88] versus 76% [70-80], p<0.05 for 50, 150 and 300ng/mL edoxaban, respectively). CONCLUSIONS: Edoxaban in vitro effect are comparable in children and adults except in the <2-year-old group

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