dc.contributor |
Háskóli Íslands |
dc.contributor |
University of Iceland |
dc.contributor.author |
Ibáñez, Luisa |
dc.contributor.author |
Sabaté, Mònica |
dc.contributor.author |
Vidal, Xavier |
dc.contributor.author |
Ballarin, Elena |
dc.contributor.author |
Rottenkolber, Marietta |
dc.contributor.author |
Schmiedl, Sven |
dc.contributor.author |
Heeke, Andreas |
dc.contributor.author |
Huerta, Consuelo |
dc.contributor.author |
Martin Merino, Elisa |
dc.contributor.author |
Montero, Dolores |
dc.contributor.author |
Leon‐Muñoz, Luz María |
dc.contributor.author |
Gasse, Christiane |
dc.contributor.author |
Moore, Nicholas |
dc.contributor.author |
Droz, Cécile |
dc.contributor.author |
Lassalle, Régis |
dc.contributor.author |
Aakjær, Mia |
dc.contributor.author |
Andersen, Morten |
dc.contributor.author |
De Bruin, Marie Louise |
dc.contributor.author |
Groenwold, Rolf |
dc.contributor.author |
Ham, Hendrika A. |
dc.contributor.author |
Souverein, Patrick |
dc.contributor.author |
Klungel, Olaf |
dc.contributor.author |
Gardarsdottir, Helga |
dc.date.accessioned |
2020-03-11T15:47:07Z |
dc.date.available |
2020-03-11T15:47:07Z |
dc.date.issued |
2019-09-04 |
dc.identifier.citation |
Ibáñez, L, Sabaté, M, Vidal, X, et al. 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. Br J Clin Pharmacol. 2019; 85: 2524– 2539. https://doi.org/10.1111/bcp.14071 |
dc.identifier.issn |
0306-5251 |
dc.identifier.issn |
1365-2125 (eISSN) |
dc.identifier.uri |
https://hdl.handle.net/20.500.11815/1586 |
dc.description |
Publisher's version (útgefin grein). |
dc.description.abstract |
Aims: To estimate the incidence of direct oral anticoagulant drug (DOAC) use in patients with nonvalvular atrial fibrillation and to describe user and treatment characteristics in 8 European healthcare databases representing 6 European countries. Methods: Longitudinal drug utilization study from January 2008 to December 2015. A common protocol approach was applied. Annual period incidences and direct standardisation by age and sex were performed. Dose adjustment related to change in age and by renal function as well as concomitant use of potentially interacting drugs were assessed. Results: A total of 186 405 new DOAC users (age ≥18 years) were identified. Standardized incidences varied from 1.93–2.60 and 0.11–8.71 users/10 000 (2011–2015) for dabigatran and rivaroxaban, respectively, and from 0.01–8.12 users/10 000 (2012–2015) for apixaban. In 2015, the DOAC incidence ranged from 9 to 28/10 000 inhabitants in SIDIAP (Spain) and DNR (Denmark) respectively. There were differences in population coverage among the databases. Only 1 database includes the total reference population (DNR) while others are considered a population representative sample (CPRD, BIFAP, SIDIAP, EGB, Mondriaan). They also varied in the type of drug data source (administrative, clinical). Dose adjustment ranged from 4.6% in BIFAP (Spain) to 15.6% in EGB (France). Concomitant use of interacting drugs varied between 16.4% (SIDIAP) and 70.5% (EGB). Cardiovascular comorbidities ranged from 25.4% in Mondriaan (The Netherlands) to 82.9% in AOK Nordwest (Germany). Conclusion: Overall, apixaban and rivaroxaban increased its use during the study period while dabigatran decreased. There was variability in patient characteristics such as comorbidities, potentially interacting drugs and dose adjustment. (EMA/2015/27/PH). |
dc.description.sponsorship |
The research leading to these results was conducted as part of the
activities of the PE‐PV Consortium (Pharmacoepidemiology and
Pharmacovigilance Consortium), which is a public academic partnership coordinated by the University of Utrecht. The project has
received support from the European Medicines Agency under the
Framework service contract (nr EMA/2015/27/PH) with regard to
the reopening of competition no3.
K. Janhsen (Witten/Herdecke University, Alfred‐Herrhausen‐
Straße 50, 58448 Witten, Germany (UW/H)) and B. Grave (AOK
NORDWEST, Kopenhagener Straße 1, 44269 Dortmund, Germany).
R. Gerlach and M. Tauscher (National Association of Statutory Health
Insurance Physicians of Bavaria, Elsenheimerstr. 39, D‐80687 Munich,
Germany).
The authors of the BIFAP database would like to acknowledge the
excellent collaboration of the primary care general practitioners and
pediatricians, and also the support of the regional governments to
the database. This study is based in part on data from the BIFAP fully
financed by the Spanish Agency on Medicines and Medical Devices
(AEMPS).
The views and opinions expressed in this article are those of the
authors and do not necessarily reflect the official policy or position
of the EMA (European Medicines Agency) or one of its committees
or working parties, or AEMPS (Agencia Española de Medicamentos y
Productos Sanitarios). |
dc.format.extent |
2524-2539 |
dc.language.iso |
en |
dc.publisher |
Wiley |
dc.relation.ispartofseries |
British Journal of Clinical Pharmacology;85(11) |
dc.rights |
info:eu-repo/semantics/openAccess |
dc.subject |
Anticoagulants |
dc.subject |
Arrhythmia |
dc.subject |
Cardiovascular |
dc.subject |
Drug utilization |
dc.subject |
Pharmacoepidemiology |
dc.subject |
Hjartsláttartruflanir |
dc.subject |
Blóðrásarsjúkdómar |
dc.subject |
Lyfjanotkun |
dc.title |
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 |
dc.type |
info:eu-repo/semantics/article |
dcterms.license |
This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
dc.description.version |
Peer Reviewed |
dc.identifier.journal |
British Journal of Clinical Pharmacology |
dc.identifier.doi |
10.1111/bcp.14071 |
dc.contributor.department |
Faculty of Pharmaceutical Sciences (UI) |
dc.contributor.department |
Lyfjafræðideild (HÍ) |
dc.contributor.school |
Heilbrigðisvísindasvið (HÍ) |
dc.contributor.school |
School of Health Sciences (UI) |