Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation
For more information on this project, please contact the EU PE&PV Research Network at eupepv@uu.nl.
Project information
- EU PE&PV research network
- EUPAS16014
- Specific Contract 01 implementing Framework service contract EMA/2015/27/PH
Full title
Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU
Principal investigator
Prof. Dr. Helga Gardarsdottir, Utrecht University
Participating organisations
- Utrecht University, The Netherlands - coordinator, consortium lead
- Aarhus University, Denmark
- University of Copenhagen, Denmark
- Klinikum der Universität München, Germany
- Universität Witten/Herdecke, Germany
- AEMPS, Spain
- FICF, Spain
Status
Completed (2018)
Deliverables
Peer-reviewed scientific publications
- Incidence of direct oral anticoagulant use in patients with nonvalvular atrial fibrillation and characteristics of users in 6 European countries (2008-2015): A cross-national drug utilization study.
Ibáñez L, Sabaté M, Vidal X, Ballarin E, Rottenkolber M, Schmiedl S, Heeke A, Huerta C, Martin Merino E, Montero D, Leon-Muñoz LM, Gasse C, Moore N, Droz C, Lassalle R, Aakjaer M, Andersen M, De Bruin ML, Groenwold R, van den Ham HA, Souverein P, Klungel O, Gardarsdottir H. Br J Clin Pharmacol. 2019 Nov;85(11):2524-2539. doi: 10.1111/bcp.14071. Epub 2019 Sep 4. PMID: 31318059 - Comparing risk of major bleeding between users of different oral anticoagulants in patients with nonvalvular atrial fibrillation.
Souverein PC, van den Ham HA, Huerta C, Merino EM, Montero D, León-Muñoz LM, Schmiedl S, Heeke A, Rottenkolber M, Andersen M, Aakjaer M, De Bruin ML, Klungel OH, Gardarsdottir H. Br J Clin Pharmacol. 2021 Mar;87(3):988-1000. doi: 10.1111/bcp.14450. Epub 2020 Jul 13. PMID: 32627222 - Prescribers' compliance with summary of product characteristics of dabigatran, rivaroxaban and apixaban-A European comparative drug utilization study.
Rottenkolber M, Schmiedl S, Ibánez L, Sabaté M, Ballarín E, Vidal X, Leon-Muñoz LM, Huerta C, Martin Merino E, Montero D, Gasse C, Andersen M, Aakjaer M, De Bruin ML, Gerlach R, Tauscher M, Souverein PC, van den Ham R, Klungel O, Gardarsdottir H; PE&PV consortium. Basic Clin Pharmacol Toxicol. 2021 Mar;128(3):440-454. doi: 10.1111/bcpt.13517. Epub 2020 Nov 2. PMID: 33037766 - Major bleeding in users of direct oral anticoagulants in atrial fibrillation: A pooled analysis of results from multiple population-based cohort studies.
van den Ham HA, Souverein PC, Klungel OH, Platt RW, Ernst P, Dell'Aniello S, Schmiedl S, Grave B, Rottenkolber M, Huerta C, Martín Merino E, León-Muñoz LM, Montero D, Andersen M, Aakjaer M, De Bruin ML, Gardarsdottir H. Pharmacoepidemiol Drug Saf. 2021 Oct;30(10):1339-1352. doi: 10.1002/pds.5317. Epub 2021 Jul 22. PMID: 34173286 - Adherence to Direct Oral Anticoagulants in Patients With Non-Valvular Atrial Fibrillation: A Cross-National Comparison in Six European Countries (2008-2015).
Sabaté M, Vidal X, Ballarin E, Rottenkolber M, Schmiedl S, Grave B, Huerta C, Martin-Merino E, Montero D, Leon-Muñoz LM, Gasse C, Moore N, Droz C, Lassalle R, Aakjær M, Andersen M, De Bruin ML, Souverein P, Klungel OH, Gardarsdottir H, Ibáñez L. Front Pharmacol. 2021 Nov 3;12:682890. doi: 10.3389/fphar.2021.682890. eCollection 2021. PMID: 34803665