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Br J Clin Pharmacol. 2019 Nov;85(11):2524-2539. doi: 10.1111/bcp.14071. Epub 2019 Sep 4.

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.

Author information

1
Fundació Institut Català de Farmacologia (FICF), Hospital Vall d'Hebron, Barcelona, Spain.
2
Department of Clinical Pharmacology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
3
Department of Pharmacology, Toxicology and Therapeutics, Universitat Autònoma de Barcelona, Spain.
4
Diabetes Research Group, Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, Germany.
5
Department of Clinical Pharmacology, School of Medicine, Faculty of Health, Witten/Herdecke University, Witten, Germany.
6
Philipp Klee-Institute for Clinical Pharmacology, Helios University Hospital Wuppertal, Wuppertal, Germany.
7
AOK NORDWEST, Dortmund, Germany.
8
Pharmacoepidemiology and Pharmacovigilance Division, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.
9
Aarhus University, Aarhus C, Denmark.
10
Bordeaux PharmacoEpi, INSERM CIC1401, Université de Bordeaux, CHU de Bordeaux, Bordeaux, France.
11
Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
12
Copenhagen Centre for Regulatory Science (CORS), Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
13
Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
14
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Faculty of Science, Universiteit Utrecht, David de Wiedgebouw, Utrecht, The Netherlands.
15
Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands.
16
Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands.
17
Faculty of Pharmaceutical Sciences, University of Iceland, Reykjavik, Iceland.

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).

KEYWORDS:

anticoagulants; arrhythmia; cardiovascular; drug utilization; pharmacoepidemiology

PMID:
31318059
DOI:
10.1111/bcp.14071

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