Background: Despite a tremendous increase in prescribing of direct oral anticoagulants (DOACs) in recent years limited data is available on prescribers' adherence to registered indications (ICs), contraindications (CIs), special warnings/precautions (SW/PCs), and potential drug-drug interactions (pDDIs). Objectives: The aim of this study was to assess in six European databases prescribers' adherence to the Summary of Product Characteristics (SmPC) of three DOAC compounds (dabigatran, rivaroxaban, and apixaban) with a special focus on IC, CI, SW/PC, and pDDI. Methods: This retrospective cohort study was conducted in databases covering regionally/nationally representative populations in five European countries (Denmark, Germany, Spain, the Netherlands, and United Kingdom). The study cohort consisted of adult patients (≥18 years) initiating dabigatran, rivaroxaban or apixaban between 2008 and 2015. ICs, CIs, SW/Ps and pDDIs as registered in the SmPC of the DOACs were mapped to respective coding systems. Results: 407,576 patients initiated DOACs during the study period (rivaroxaban: 240,985 [59.1%], dabigatran: 95,303 [23.4%], apixaban: 71,288 [17.5%]). In 2015, non-valvular atrial fibrillation was the most common IC registered, representing more than 60% of incident DOAC users in most databases. For the whole study period, a substantial variety between the databases was found regarding the proportion of patients with at least one CI (interdatabase range [IDR]: 8.2% to 55.7%), with at least one SW/PC (IDR: 35.8% - 75.2%), and with at least one pDDI (22.4% to 54.1%). In 2015, the most frequent CI was 'malignant neoplasm' (IDR: 0.7% - 21.3%) whereas the most frequent SW/Pc were 'prescribing to the elderly (75 years or older)' with an IDR from 25.0% to 66.4%. The most common single compound class pDDI was 'concomitant use of nonsteroidal antinflammatory drugs' with an IDR between 3.0% to 25.3%. Conclusions: CIs, SW/Ps, and pDDIs were present in a significant number of new DOAC users. Differences between all databases might be related to 'true' differences in prescription behaviour, but could also be partially due to differences in database characteristics.
Original languageEnglish
Pages (from-to)148-149
Number of pages2
JournalPharmacoepidemiology and Drug Safety
Issue numberS2
Publication statusPublished - Aug 2019
Event35th International conference on Pharmacoepidemiology & therapeutic risk management. - Pennsylvania Convention Center, Philapdelphia, United States
Duration: 24 Aug 201928 Aug 2019


  • apixaban
  • dabigatran
  • rivaroxaban
  • adult
  • aged
  • atrial fibrillation
  • cohort analysis
  • conference abstract
  • contraindication
  • controlled study
  • Denmark
  • drug therapy
  • drug utilization
  • female
  • Germany
  • human
  • major clinical study
  • male
  • malignant neoplasm
  • Netherlands
  • prescription
  • retrospective study
  • Spain
  • United Kingdom


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