Atrial Fibrillation
Conditions
Brief summary
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non0-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
Detailed description
This is a comparative effectiveness and safety study of clinical events among patients taking either dabigatran or warfarin. There is no formal hypothesis to be tested, but rather to provide the estimates on the incidence of stroke and systemic embolism (effectiveness) and bleeding events (safety) using 95% confidence interval for comparison between those non-valvular atrial fibrillation patients taking dabigatran vs. warfarin using a large, nation-wide claims data in Japan.
Interventions
DRUGWarfarin
patients treated with warfarin
DRUGDabigatran
patients treated with Dabigatran
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged \>18 year-old with confirmed diagnosis of Non-Valvular Atrial Fibrillation (NVAF) (ICD 10 code I48) * having a first prescription (index date) of either dabigatran or warfarin between 14 March 2011 to 30 June 2016 * having no prescription of any Oral Anticoagulants (OACs) for 12 months prior to the index date (this period is defined as the baseline period)
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 atrial fibrillation (AF) * mechanical valve placement, rheumatic AF * and/or mitral valve prolapse/regurge/stenosis in baseline period * having record of deep vein thrombosis or pulmonary embolism \< 6 months before AF diagnosis in baseline period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Stroke and Systemic Embolism (SE) | From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years. | Incidence rate of stroke and systemic embolism (SE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Major Bleeding | From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years. | Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims. |
Countries
Japan
Participant flow
Recruitment details
A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.
Pre-assignment details
The Japanese patients diagnosed as Non-Valvular Atrial Fibrillation (NVAF) and newly treated with dabigatran and warfarin in the real world Japanese setting between April 2010 and June 2016 using the Medical Data Vision (MDV) database.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. | 5,146 |
| Warfarin Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation. | 13,115 |
| Total | 18,261 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not eligible patients | 599 | 3,630 |
Baseline characteristics
| Characteristic | Dabigatran | Warfarin | Total |
|---|---|---|---|
| Age, Continuous | 72 Years STANDARD_DEVIATION 10 | 78 Years STANDARD_DEVIATION 10 | 76 Years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1695 Participants | 5294 Participants | 6989 Participants |
| Sex: Female, Male Male | 3451 Participants | 7821 Participants | 11272 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence Rate of Stroke and Systemic Embolism (SE)
Incidence rate of stroke and systemic embolism (SE).
Time frame: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of stroke and systemic embolism, ie., up to 6.5 years.
Population: Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Incidence Rate of Stroke and Systemic Embolism (SE) | 2.898 per patient-year |
| Warfarin | Incidence Rate of Stroke and Systemic Embolism (SE) | 3.563 per patient-year |
Comparison: There was no formal hypothesis testing.95% CI: [0.534, 0.97]
Secondary
Incidence Rate of Major Bleeding
Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.
Time frame: From the index date to end of treatment with > 14 day grace period, switch to another OAC, end of continuous enrolment, end of study period or death, outcome event of major bleeding, ie., up to 6.5 years.
Population: Eligible patient who were prescribed dabigatran and warfarin as the first OACs and matched 1: 1 using the propensity score matching (PSM).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran | Incidence Rate of Major Bleeding | 0.639 per patient-year |
| Warfarin | Incidence Rate of Major Bleeding | 1.128 per patient-year |
Comparison: There was no formal hypothesis testing.95% CI: [0.303, 0.994]