Medical Need of Non-vitamin K Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Emergency Surgery, Trauma and Fracture, using Large Scale Claims Database

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN

  RIVAROXABAN

  EDOXABAN

  APIXABAN

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

  dabigatran etexilate

  (B01AF01) rivaroxaban

  rivaroxaban

  (B01AF03) edoxaban

  edoxaban

  (B01AF02) apixaban

  apixaban

  (B01AA03) warfarin

  warfarin
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Inclusion criteria ; 1. >18 year old non-valvular atrial fibrillation (NVAF) patients; 2. Prescribed dabigatran, rivaroxaban, apixaban, edoxaban or warfarin ; 3. Patients with confirmed date of initiation of OACs; 4. Patients with a minimum of 6 months of enrolment data prior to index date; 5. Has an index date between 14th of March 2011 to 30 June, 2016; Exclusion criteria; 1. Patients receiving two or more oral anti-coagulants at the same time at index date; 2. Patients with prescriptions of index treatment in the 6 months prior to index date; 3. Patients without enrolment period of at least six month in the database
• 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:
  62888

Study design details

• Study design:
  Non-interventional study based on existing health insurance claims data.
• Main study objective:
  The primary objective of this study is to assess the incidence rates of emergency surgery and major bleeding associated with fracture and trauma. Secondary objective is to assess the incidence rates of cardiac tamponade and pericardiocentesis.A further objective is to describe the types of emergency surgeries identified
• Setting:
  MDV clinical database is used.
• Outcomes:
  For the primary objectiveIncidence rate (overall and age stratified) of emergency surgery and major bleeding due to fracture/trauma will be described with number of patients presenting the event, patient-years and 95% confidence interval overall and stratified by age. For the secondary objectiveIncidence rates (overall and age stratified) of cardiac tamponade and peri-cardiocentesis, along with number of events, patient year of follow-up not including time after switch, and 95% confidence interval. For the further objective
• Data analysis plan:
  Incidence of emergency surgery, major bleeding due to fracture and trauma during the on-treatment follow-up in the claims database with number of patients presenting the event, patient-years and 95% confidence interval overall and stratified by age.
• Summary results:
  The number of patients meeting the inclusion and exclusion criteria was 53,969. The age (average±standard deviation (SD)) and percentage of female in these patients were 76±10 with 40% female. Followings are the ; results of the analyses which included time after switch of OAC. Age stratified data are described in parenthesis. The number of patients with emergency surgery or major bleeding due to fracture/trauma was 133 (14, ; 35, and 84 for the patient group with age <=64, 65-74 and >=75, respectively). The number of patients with cardiac tamponade and pericardiocentesis was 1. The number of patients with emergency surgery ; of cardiovascular system was 30 (2, 9, and 19 for the patient group with age <=64, 65-74 and >=75, respectively). The number of patients with emergency surgery of abdomen was 39 (5, 10, and 24 for the patient group with age <=64, 65-74 and >=75, respectively). The number of patients with emergency surgery of urinary system/adrenal glands was 3 (1, 2, and 0 for the patient group with age <=64, 65-74 and >=75, respectively). ; Comparable results were obtained from analyses which excluded time after switch of OAC. Patient characteristics showed that arterial hypertension was the most frequent diseases within 6 months baseline period. The average±SD of Charlson co-morbidity index was 1.7±2.1. As concomitant medication with OAC, amiodarone and clopidogrel were prescribed in less than 10% of the patients, whereas the other investigated medications were prescribed in over 10 % of the patients.