Treatment Pattern of Oral Anticoagulants (OAC) in Japan

Study Overview
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Brief Summary
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To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates. As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database

Official Title
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Treatment Patterns of Newly Initiated Oral Anticoagulants on Japanese Non-valvular Atrial Fibrillation Patients Using a Japanese Claims Database

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients aged >18 year-old with confirmed diagnosis of NVAF (ICD 10 code I48), being new starters of either dabigatran, warfarin, apixaban or edoxaban, having no prescription of other OACs for12 months prior to the index date (defined as the first prescription of OACs (the period is defined as baseline period)), and having an index date between 14 Mar 2011 to 30 June 2016 Exclusion criteria: Patients having less than 12 months of enrolment prior to the index date , being dialysis or kidney transplant recipients in baseline period, having either atrial flutter, valvular AF, mechanical valve placement, rheumatic AF, and/or mitral valve prolapse/regurge/stenosis in baseline period, and having record of deep vein thrombosis or pulmonary embolism < 6 months before Atrial Fibrillation (AF) diagnosis in baseline period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Patients<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF | Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF) | Day 1 | 
| Number of Patients Prescribed OAC Drug Dabigatran by Dosage | Number of patients prescribed OAC drug dabigatran at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 | 
| Number of Patients Prescribed OAC Drug Warfarin by Dosage | Number of patients prescribed OAC drug Warfarin at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 | 
| Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage | Number of patients prescribed OAC drug rivaroxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 | 
| Number of Patients Prescribed OAC Drug Apixaban by Dosage | Number of patients prescribed OAC drug Apixaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 | 
| Number of Patients Prescribed OAC Drug Edoxaban by Dosage | Number of patients prescribed OAC drug edoxaban at the index date by dosage. If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline Characteristics: Age | Baseline characteristics of patients in each treatment group: age | 1 day | 
| Baseline Characteristics: Gender | Baseline characteristics of patients in each treatment group: gender | Day 1 | 
| Baseline Characteristics: Year of Initiating Treatment | Baseline characteristics of patients in each treatment group: year of initiating treatment | Day 1 | 
| Baseline Characteristics: Speciality of Prescribers of OAC | Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC. int.= internal; Med.= Medicine | Day 1 | 
| Baseline Characteristics: History of Disease | Baseline characteristics of patients in each treatment group: history of disease and hospitalization. | Day 1 | 
| Baseline Characteristics: History of Hospitalization | Baseline characteristics: history of hospitalization | Day 1 | 
| Baseline Characteristics: AF Risk Score | Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk. HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk. | Day 1 | 
| Baseline Characteristics: Concomitant Medication | Baseline characteristics of patients in each treatment group: concomitant medication | Day 1 |