Efficacy and Safety of Non-Vitamin K Antagonist Oral Anticoagulants in Pediatric Venous Thromboembolism Treatment and Thromboprophylaxis: A Systematic Review of the Literature.

Autor:	Branstetter JW; Department of Pharmacy, Children's Healthcare of Atlanta, Atlanta, Georgia., Kiskaddon AL; Department of Pharmacy, The Johns Hopkins All Children's Hospital, St. Petersburg, Florida.; Johns Hopkins All Children's Institute for Clinical and Translational Research, St. Petersburg, Florida., King MA; Department of Pharmacy, C.S. Mott Children's Hospital, Ann Arbor, Michigan., Coalter C; College of Pharmacy, Union University, Jackson, Tennessee., Grubbs KM; Department of Pharmacy, Medical University of South Carolina, Charleston, South Carolina., Fly H; Department of Pharmacy, Le Bonheur Children's Hospital, Memphis, Tennessee., Male C; Department of Paediatrics, Medical University of Vienna, Austria., Brandão L; Division of Haematology/Oncology, Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.; Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada., Goldenberg NA; Johns Hopkins All Children's Institute for Clinical and Translational Research, St. Petersburg, Florida.; Thrombosis Program, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.; Department of Pediatrics and Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Jazyk:	angličtina
Zdroj:	Seminars in thrombosis and hemostasis [Semin Thromb Hemost] 2021 Sep; Vol. 47 (6), pp. 643-653. Date of Electronic Publication: 2021 May 10.
DOI:	10.1055/s-0041-1725944
Abstrakt:	Venous thromboembolism (VTE) in children can lead to significant morbidity and mortality. Traditionally, treatment for thrombotic events in pediatric patients has been limited mainly to unfractionated heparin, low-molecular-weight heparin (LMWH), or vitamin K antagonists. Since the first non-vitamin K antagonist oral anticoagulant (NOAC) was approved for adult use, these agents have gained popularity for a variety of indications. This is largely due to their ease of administration, favorable pharmacokinetic and pharmacodynamic profile, decreased food interactions, and decreased need for therapeutic drug monitoring. Treating and preventing VTE with traditional anticoagulants in pediatric patients presents many challenges. This systematic review evaluated the current literature regarding pediatric NOAC trials. Additionally, based on an up-to-date query of clinicaltrials.gov , we detail current ongoing and as-yet unpublished clinical trials, study outcomes, and projected completion dates. Published pediatric NOAC trials have included 1,007 total children to date and have ranged from phase 1 to 4, with "indications" including both thromboembolism prophylaxis and VTE treatment. Three recent phase 3 trials, specifically involving rivaroxaban and dabigatran, have shown the agents to be at least as effective as traditional anticoagulants for acute and/or extended VTE treatment, with low frequency of recurrent thrombosis and clinically significant bleeding rates. Additionally, specially developed and tested pediatric formulations have allowed for accurate and reliable dosing, oral administration, stable pharmacokinetics and pharmacodynamics, and fewer drug or food interactions. Ongoing trials, anticipated for completion in the next few years, will reveal important information with regard to thromboembolism prophylaxis in special pediatric subpopulations and settings. Competing Interests: L.B. reports other from Boehringer Ingelheim (BI), specifying research support and participation as a board study member; C.M. reports grants and personal fees from Bayer AG, Boehringer-Ingelheim, Bristol Myers Squibb, and Pfizer; N.A.G. reports other from Bayer, outside the submitted work; and N.A.G. receives research support and salary support from the National Institutes of Health, National Heart Lung, and Blood Institute for clinical and translational investigation in venous thromboembolism in patients younger than 21 years. N.A.G. receives consultancy fees from Daiici Sankyo Inc., Anthos Therapeutics Inc., and the Academic Research Organization CPC Clinical Research for roles in clinical trial oversight committees (e.g., steering, data and safety monitoring) in pharmaceutical industry–sponsored pediatric clinical trials of antithrombotic agents. J.W.B., C.C., H.F., K.M.G., M.A.K., and A.L.K. do not have any conflicts of interest to disclose. (Thieme. All rights reserved.)
Databáze:	MEDLINE
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