Impact of the COVID-19 pandemic in a cohort of anticoagulant users: a descriptive drug utilization study based on data from the Tuscany Healthcare administrative database

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  dabigatran etexilate

  (B01AF01) rivaroxaban

  rivaroxaban

  (B01AF02) apixaban

  apixaban

  (B01AF03) edoxaban

  edoxaban

  (B01AA) Vitamin K antagonists

  Vitamin K antagonists

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  130000

Study design details

• Main study objective:
  The aim of the study is to conduct a time-trend analysis in order to observe: 1. Possible changes in prevalence and incidence of VKAs and DOACs use potentially associated with COVID-19 pandemic2. Possible changes in the secular trends of switch from VKAs to DOACs potentially associated with COVID-19 pandemic
• Outcomes:
  1) number of switchers during follow-up, 2) number of interrupters during follow-up
• Data analysis plan:
  The prevalent/incident users, switchers and interrupters will be calculated on a weekly basis during the entire observation period (01/01/2019-30/06/2020). To evaluate the effect of COVID-19 pandemic prescribing patterns of VKAs/DOACs before and after the 9th of March 2020, which is the date of the official lockdown, an interrupted time series (ITS) analysis will be carried out.