Apixaban drug utilization study in Stroke prevention in atrial fibrillation (SPAF)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01A) ANTITHROMBOTIC AGENTS

  ANTITHROMBOTIC AGENTS
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Individuals diagnosed with non-valvular atrial fibrillation (NVAF) from source population who had a new prescription for apixaban, VKA (warfarin or acenocoumarol), dabigatran or rivaroraban from August 2013 until December 2015 and a previously recorded diagnostic of NVAF.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Atrial fibrillation patients
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  The primary research question is to evaluate the apixaban utilization according to the approved SPAF indication and recommendations by EMA.In addition a comparison with a cohort of NVAF patients treated with VKA, dabigatran and rivaroxaban for the SPAF indication will also be performed.
• Outcomes:
  To characterize patients using apixaban according to demographics, comorbidity, risk of thromboembolic events (CHADS2 and CHA2DS2-Vasc scores), risk of bleeding events (HAS-BLED score), comedications and compare it with the profile of patients treated with VKA, dabigatran and rivaroxaban. Describe the level of appropriate usage according to the posology recommended in the apixaban SmPCDescribe the potential interactions with other drugs prescribed concomintatly according with the SmPC recommendationsEstimate the level of apixaban adherence by the medication possession ratio (MPR) and discontinuation rates and compare it with VKA, dabigatran and rivaroxabanTo analyze INR
• Data analysis plan:
  The use and patterns of use of Apixaban and VKA will be summarised by the total number of users, prescriptions, and number of DDDs, and by the number of users according to daily dose and duration of use. Characteristics of users, comorbidity, comedications, use of interacting drugs will be described as number and percentage of patients with each condition. The number and percentage of all variables will be calculated by apixaban VKA, dabigatran and rivaroxaban group. In general, frequencies will be used to describe the study sample characteristics and characteristics of each category group. Chi-square tests and ANOVA will be utilized to compare categorical and continuous variables, respectively, across the category groups.