1. Characteristics of patients initiated on edoxaban in Europe: baseline data from edoxaban treatment in routine clinical practice for patients with atrial fibrillation (AF) in Europe (ETNA-AF-Europe).
- Author
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De Caterina R, Kelly P, Monteiro P, Deharo JC, de Asmundis C, López-de-Sá E, Weiss TW, Waltenberger J, Steffel J, de Groot JR, Levy P, Bakhai A, Zierhut W, Laeis P, Kerschnitzki M, Reimitz PE, and Kirchhof P
- Subjects
- Administration, Oral, Aged, Aged, 80 and over, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Drug Labeling, Drug Utilization, Europe epidemiology, Factor Xa Inhibitors adverse effects, Female, Guideline Adherence, Hemorrhage chemically induced, Hemorrhage epidemiology, Humans, Male, Middle Aged, Practice Guidelines as Topic, Product Surveillance, Postmarketing, Pyridines adverse effects, Registries, Risk Assessment, Risk Factors, Stroke diagnosis, Stroke epidemiology, Thiazoles adverse effects, Time Factors, Treatment Outcome, Atrial Fibrillation drug therapy, Factor Xa Inhibitors administration & dosage, Practice Patterns, Physicians', Pyridines administration & dosage, Stroke prevention & control, Thiazoles administration & dosage
- Abstract
Background: Non-vitamin K antagonist (VKA) oral anticoagulants (NOACs) have substantially improved anticoagulation therapy for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). The available routine care data have demonstrated the safety of different NOACs; however, such data for edoxaban are scarce. Here, we report baseline characteristics of 13,638 edoxaban-treated patients with AF enrolled between November 2016 and February 2018., Methods: ETNA-AF-Europe is a multinational, multi-centre, post-authorisation, observational study conducted in 825 sites in 10 European countries. Patients will be followed up for four years., Results: Overall, 13,980 patients were enrolled of which 342 patients were excluded from the analysis. Mean patient age was 73.6 years with an average creatinine clearance of 69.4 mL/min. 56.6% were male. The calculated CHA
2 DS2 -VASc and HAS-BLED mean scores were 3.1 and 2.6, respectively. Overall, 3.3, 14.6 and 82.0% of patients had low (CHA2 DS2 -VASc = 0), intermediate (CHA2 DS2 -VASc = 1) and high (CHA2 DS2 -VASc≥2) risks of stroke, respectively. High-risk patients (those with prior stroke, prior major bleeding, prior intracranial bleed or CHA2 DS2 -VASc ≥4) comprised 38.4% of the overall population. For 75.1% of patients edoxaban was their first anticoagulant prescription, whilst 16.9% switched from a VKA and 8.0% from another NOAC. A total of 23.4% of patients in ETNA-AF-Europe received the reduced dose of edoxaban 30 mg. Overall, 83.8% of patients received an edoxaban dose in line with the criteria outlined in the label., Conclusion: Edoxaban was predominantly initiated in older, often anticoagulation-naïve, unselected European patients with AF, with a good overall adherence to the approved label., Trial Registration: NCT02944019; Date of registration: October 24, 2016.- Published
- 2019
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