Risk Profiles of New Users of Oral Anticoagulants Between 2011 and 2019 in Germany

Annemarie Voss; Bianca Kollhorst; Katharina Platzbecker; Ute Amann; Ulrike Haug

doi:10.2147/CLEP.S405585

Risk Profiles of New Users of Oral Anticoagulants Between 2011 and 2019 in Germany

Clin Epidemiol. 2023 Jul 18:15:827-837. doi: 10.2147/CLEP.S405585. eCollection 2023.

Authors

Annemarie Voss¹, Bianca Kollhorst², Katharina Platzbecker¹, Ute Amann¹, Ulrike Haug^{1

3}

Affiliations

¹ Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
² Department of Biometry and Data Management, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
³ Faculty of Human and Health Sciences, University of Bremen, Bremen, Germany.

Abstract

Purpose: Over the last decade, the use of direct oral anticoagulants (DOACs) has strongly increased. We aimed to describe and compare risk profiles including potential changes over time among persons with non-valvular atrial fibrillation initiating treatment with different DOACs or phenprocoumon (vitamin K antagonist) between 2011 and 2019 in Germany.

Patients and methods: Using the German Pharmacoepidemiological Research Database (GePaRD; claims data of ~20% of the German population), we identified persons with a first dispensing of phenprocoumon or a DOAC and a diagnosis of non-valvular atrial fibrillation between August 2011 and December 2019. We described the morbidity of included patients prior to treatment initiation, stratified by year of treatment initiation.

Results: Overall, we included 448,028 new users (phenprocoumon: N = 118,117, rivaroxaban: N = 130,997, apixaban: N = 130,300, edoxaban: N = 38,128, dabigatran: N = 30,486). Comparing new DOAC users in 2019, the proportion with prior ischemic stroke was highest for dabigatran (17%) and lowest for rivaroxaban (8%). The proportion with prior major bleeding was also highest for dabigatran (25%) and lowest for edoxaban (20%). New users of apixaban were oldest and, eg, showed the highest prevalence of congestive heart failure. Changes over time were most pronounced for phenprocoumon. For example, among persons initiating phenprocoumon in 2012 vs 2019, the proportion with prior major bleeding increased from 18% to 35%; the proportion with renal disease increased from 20% to 36% and the proportion with liver disease from 18% to 24%.

Conclusion: This study demonstrated differences in risk profiles between new users of different oral anticoagulants and substantial changes over time among new phenprocoumon users. These differences have to be considered in head-to-head comparisons of these drugs based on observational data, especially regarding potential unmeasured confounding.

Keywords: DOACs; atrial fibrillation; direct oral anticoagulants; oral anticoagulants; risk profiles.