Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comparative Study
. 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

Luisa Ibáñez  1   2   3 , Mònica Sabaté  1   2   3 , Xavier Vidal  1   2   3 , Elena Ballarin  1   2 , Marietta Rottenkolber  4 , Sven Schmiedl  5   6 , Andreas Heeke  7 , Consuelo Huerta  8 , Elisa Martin Merino  8 , Dolores Montero  8 , Luz María Leon-Muñoz  8 , Christiane Gasse  9 , Nicholas Moore  10 , Cécile Droz  10 , Régis Lassalle  10 , Mia Aakjaer  11 , Morten Andersen  11 , Marie Louise De Bruin  12 , Rolf Groenwold  13 , Hendrika A van den Ham  14 , Patrick Souverein  14 , Olaf Klungel  14   15 , Helga Gardarsdottir  15   16   17
Affiliations
Comparative Study

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

Luisa Ibáñez et al. Br J Clin Pharmacol. 2019 Nov.

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.

PubMed Disclaimer

Conflict of interest statement

N.M.: Bordeaux PharmacoEpi has done 2 postauthorisation studies of comparative effectiveness and safety of DOAC compared to VKA, requested by the French regulatory authorities and financed by the respective marketing authorisation holders. These studies do not concern drug utilisation and do not represent a conflict of interest.

O.K. has provided an educational lecture (nonproduct related) for Roche in May 2017.

M.An. reports research grants from AstraZeneca, H. Lundbeck & Mertz, Janssen, Merck Sharp & Dohme, Novartis, Nycomed, and Pfizer, received by the institutions at which he has been employed. M.An. has received fees for organising and teaching pharmacoepidemiology courses at Medicademy, the Danish Association for the Pharmaceutical Industry. M.An.'s professorship is supported by a grant from the Novo Nordisk Foundation to the University of Copenhagen (NNF15SA0018404).

Figures

Figure 1
Figure 1
Distribution of the total standardized incidence by individual direct oral anticoagulant (DOAC; 2011–2015)
Figure 2
Figure 2
Standardized incidences by individual direct oral anticoagulant in each database
Figure 3
Figure 3
Standardized and crude incidence for all direct oral anticoagulants per year and database
See this image and copyright information in PMC

References

    1. Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016;37:2893‐2962. 10.1093/eurheartj/ehw210 - DOI - PubMed
    1. Björck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population‐based study. Stroke. 2013;44(11):3103‐3108. 10.1161/STROKEAHA.113.002329 - DOI - PubMed
    1. Haim M, Hoshen M, Reges O, Rabi Y, Balicer R, Leibowitz M. Prospective national study of the prevalence, incidence, management and outcome of a large contemporary cohort of patients with incident non‐valvular atrial fibrillation. J am Heart Assoc. 2015;4(1):e001486 10.1161/JAHA.114.001486 - DOI - PMC - PubMed
    1. Stewart S, Hart CL, Hole DJ, McMurray JJ. A population‐based study of the long‐term risks associated with atrial fibrillation: 20‐year follow‐up of the Renfrew/Paisley study. Am J Med. 2002;113(5):359‐364. 10.1016/s0002-9343(02)01236-6 - DOI - PubMed
    1. Hart RG, Pearce LA, Aguilar MI. Meta‐analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007;146(12):857‐867. 10.7326/0003-4819-146-12-200706190-00007 - DOI - PubMed

Publication types

MeSH terms

LinkOut - more resources