title: Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA).
abstract: In contrast to vitamin K antagonists, no routine coagulation monitoring is required in patients taking non-vitamin-K oral anticoagulants (NOACs). However, dosing must take into account factors such as patient age, renal function, and accompanying haemorrhagic risk. There has been considerable debate about when laboratory measurement might be appropriate and which tests should be used. A workshop at the European Medicines Agency recently discussed the evidence about laboratory measurement from formal studies, clinical experience, and the multiple perspectives on NOAC treatment, and considered how our knowledge might be further enhanced.
authors.affiliation: Committee Chair, Committee for Medicinal Products for Human Use, EMA, London E14 5EU, UK.
authors.forename: Tomas
authors.initials: T
authors.lastname: Salmonson
authors.affiliation: Committee Member, Pharmacovigilance Risk Assessment Committee, EMA, London E14 5EU, UK.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Dogné
authors.affiliation: Head of Office, Endocrinology, Metabolism & Cardiovascular Office, EMA, London E14 5EU, UK.
authors.forename: Heidi
authors.initials: H
authors.lastname: Janssen
authors.affiliation: Head of Service, Medical and Health Information Service, EMA, London E14 5EU, UK.
authors.forename: Juan
authors.initials: J
authors.lastname: Garcia Burgos
authors.affiliation: Scientific Officer, Medical and Health Information Service, EMA, London E14 5EU, UK paul.blake@ema.europa.eu.
authors.forename: Paul
authors.initials: P
authors.lastname: Blake
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage*; D001777:Blood Coagulation / Q000187:drug effects*; D002309:Cardiology / Q000193:education*; D004501:Education, Medical; D005060:Europe; D006801:Humans; D012955:Societies, Medical; D020521:Stroke / Q000097:blood / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants
keywords: Anticoagulation ; Coagulation tests; DOACs; Direct Oral Anticoagulants; NOACs ; Non-vitamin-K oral anticoagulants 