Treatment Patterns of newly initiated oral anticoagulants on Japanese non-vascular atrial fibrillation patients using a Japanese claims database

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Primary data collection

Study drug and medical condition

• Medicinal product name:
  ELIQUIS

  XARELTO
• Medicinal product name, other:
  warfarin, Prazaxa
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AA03) warfarin

  warfarin

  (B01AE07) dabigatran etexilate

  dabigatran etexilate
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  480000

Study design details

• Study design:
  A retrospective, observational study using health insurance claims data
• Main study objective:
  The main objective to evaluate the number of non-valvular atrial fibrillation patients newly treated with oral anticoagulants between the period of March 2011 to June 2016 and type/dose of oral anti-coagulants these patients have received.
• Setting:
  MDV clinical database between April 2010 and June 2016 was used.
• Outcomes:
  Type and dose of newly prescribed anti-coagulant to AF patients, Patient baseline characteristics including past medical history, demographics and concurrent drug treatment
• Data analysis plan:
  Descriptive statistics of each oral anti-coagulant for baseline characteristics and treatment status on index date defined as the date of first prescription of anti-coagulant. Exploratory analysis to use propensity score matching method to see if treatment groups can be matched using various co-variates such as clinical history, gender, age, previous and concomittant medication, year and month of index date, time from AF diagnosis, type and dose of oral anti-coagulant.
• Summary results:
  Among the patients diagnosed as NVAF between April 2010 and June 2016, 48,696 patients were prescribed dabigatran, warfarin, apixaban, edoxaban, or rivaroxaban as the first OACs. Among them, the number of ; eligible patients for those prescribed dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban as the first OAC were 4,943, 12,497, 11,415, 8,767, or 2,272, respectively. Some baseline characteristics such as age ; distribution, history of hospitalization, some AF risk factor scores, distribution of year of initiating treatment, and some concomitant medication were different among the treatment groups.After propensity score matching based on matching ratio of 1:1, using caliper factor of 0.10, it was confirmed that the distribution of propensity ; score was similar between the patients prescribed dabigatran and warfarin.The number of matching patients after the matching was 4,421 for both treatment groups. There was no background factor with standardized; difference at more than 0.1.