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Hamostaseologie 2022; 42(01): 046-053
DOI: 10.1055/a-1703-0821
Review Article

Anticoagulation in Pediatric Patients

Christoph Male
1   Department of Paediatrics, Medical University of Vienna, Vienna, Austria
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Abstract

Special aspects of anticoagulation in children include the different epidemiology of thrombosis, developmental changes in the coagulation system, age-dependent pharmacokinetics of anticoagulants, risk of bleeding, and practical hurdles to anticoagulation. The classical anticoagulants so far used in children have several limitations, resulting in the need for regular monitoring. The pharmacological properties of direct oral anticoagulants (DOACs) and the special challenges of anticoagulation in children make the DOACs particularly attractive for children. All DOACs have pediatric development programs, targeting various indications for prevention and treatment of thrombosis. Child-appropriate formulations have been developed, age-specific dosing information generated, and safety and efficacy evaluated in ongoing phase 3 trials. Rivaroxaban and dabigatran have already been authorized for children for treatment of acute venous thrombosis and for extended secondary prevention. Their safety and efficacy have been demonstrated comparable to that of standard-of-care anticoagulants, without need for monitoring. Further studies are ongoing, which are expected to lead to pediatric authorizations of DOACs for primary venous thromboembolic event prevention in some high-risk settings. More real-life data will be necessary from postmarketing studies and registries to complement the evidence base for DOAC use in children, particularly in the youngest age groups and special disease populations.

Zusammenfassung

Spezielle Aspekte der Antikoagulation bei Kindern umfassen die unterschiedliche Epidemiologie von Thrombosen, entwicklungsbedingte Veränderungen im Gerinnungssystem, altersabhängige Pharmakokinetik von Antikoagulantien, Blutungsrisiko und praktische Hürden für die Antikoagulation. Die bislang bei Kindern eingesetzten klassischen Antikoagulantien haben zahlreiche Limitationen, weswegen sie regelmäßiges Monitoring erfordern.

Die pharmakologischen Eigenschaften der direkten oralen Antikoagulantien (DOAKs) und die speziellen Herausforderungen von Antikoagulation bei Kindern machen die DOAKs für Kinder besonders attraktiv. Alle DOAKs haben pädiatrische Entwicklungsprogramme, die auf verschiedene Indikationen von Prävention und Behandlung von Thrombosen abzielen. Kindergerechte pharmazeutische Formulierungen wurden entwickelt, altersspezifische Dosisinformation generiert, und Sicherheit und Wirksamkeit werden in laufenden Phase 3 Studien evaluiert.

Rivaroxaban und Dabigatran erhielten bereits Zulassungen für Kinder für die Behandlung der akuten Venenthrombose und längerfristige sekundäre Prophylaxe. Ihre Sicherheit und Wirksamkeit zeigten sich jener von Standardantikoagulantien vergleichbar, ohne die Notwendigkeit für Monitoring. Weitere Studien sind noch am Laufen, welche voraussichtlich zu pädiatrischen Zulassungen von DOAKs für primäre Thromboprophylaxe in verschiedenen Hochrisikosituationen führen werden. Im Weiteren werden noch mehr Daten aus der Anwendung in der Praxis aus Postmarketing-Studien und Registern erforderlich sein, um die Evidenzbasis für die Anwendung von DOAKs bei Kindern zu erweitern, besonders für die jüngsten Altersgruppen und Kinder mit speziellen Erkrankungen.

Keywords

children - anticoagulation - thromboprophylaxis - direct oral anticoagulants

Schlüsselwörter

Kinder - Antikoagulation - Thromboprophylaxe - direkte orale Antikoagulantien


Publication History

Received: 20 October 2021

Accepted: 21 November 2021

Article published online:
18 January 2022

© 2022. Thieme. All rights reserved.

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Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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