1. Apixaban for Prevention of Thromboembolism in Pediatric Heart Disease
- Author
-
Payne, R Mark, Burns, Kristin M, Glatz, Andrew C, Male, Christoph, Donti, Andrea, Brandão, Leonardo R, Balling, Gunter, VanderPluym, Christina J, Bu'Lock, Frances, Kochilas, Lazaros K, Stiller, Brigitte, Cnota, James F, Rahkonen, Otto, Khan, Asra, Adorisio, Rachele, Stoica, Serban, May, Lindsay, Burns, Jane C, Saraiva, Jose Francisco K, McHugh, Kimberly E, Kim, John S, Rubio, Agustin, Chía-Vazquez, Nadia G, Meador, Marcie R, Dyme, Joshua L, Reedy, Alison M, Ajavon-Hartmann, Toni, Jarugula, Praneeth, Carlson-Taneja, Lauren E, Mills, Donna, Wheaton, Olivia, and Monagle, Paul
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Sciences ,Orphan Drug ,Heart Disease ,Hematology ,Pediatric ,Clinical Research ,Women's Health ,Rare Diseases ,Prevention ,Patient Safety ,Cardiovascular ,Clinical Trials and Supportive Activities ,6.1 Pharmaceuticals ,Child ,Humans ,Infant ,Newborn ,Anticoagulants ,Fibrinolytic Agents ,Heart Diseases ,Hemorrhage ,Heparin ,Low-Molecular-Weight ,Pyridones ,Quality of Life ,Venous Thromboembolism ,Vitamin K ,anticoagulation ,apixaban ,congenital ,heart ,pediatric ,thromboembolism ,Cardiorespiratory Medicine and Haematology ,Public Health and Health Services ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
BackgroundChildren with heart disease frequently require anticoagulation for thromboprophylaxis. Current standard of care (SOC), vitamin K antagonists or low-molecular-weight heparin, has significant disadvantages.ObjectivesThe authors sought to describe safety, pharmacokinetics (PK), pharmacodynamics, and efficacy of apixaban, an oral, direct factor Xa inhibitor, for prevention of thromboembolism in children with congenital or acquired heart disease.MethodsPhase 2, open-label trial in children (ages, 28 days to
- Published
- 2023