Trial Outcomes & Findings for Comparative Effectiveness and Safety Between Warfarin and Dabigatran (NCT NCT03254134)

Results Overview

Incidence rate of stroke and systemic embolism (SE).

Recruitment status

COMPLETED

Target enrollment

22490 participants

Primary outcome timeframe

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.

Results posted on

2019-07-09

Participant Flow

A non-interventional study based on existing health insurance claims data. 5,146 and 13,115 patients were prescribed dabigatran and warfarin.

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.

Participant milestones

Participant milestones
Measure	Dabigatran Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.	Warfarin Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Overall Study STARTED	5745	16745
Overall Study COMPLETED	5146	13115
Overall Study NOT COMPLETED	599	3630

Reasons for withdrawal

Reasons for withdrawal
Measure	Dabigatran Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.	Warfarin Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Overall Study Not eligible patients	599	3630

Baseline Characteristics

Eligible patients who were prescribed dabigatran and warfarin as the first OACs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dabigatran n=5146 Participants Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.	Warfarin n=13115 Participants Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.	Total n=18261 Participants Total of all reporting groups
Age, Continuous	72 Years STANDARD_DEVIATION 10 • n=5146 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs	78 Years STANDARD_DEVIATION 10 • n=13115 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs	76 Years STANDARD_DEVIATION 10 • n=18261 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs
Sex: Female, Male Female	1695 Participants n=5146 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs	5294 Participants n=13115 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs	6989 Participants n=18261 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs
Sex: Female, Male Male	3451 Participants n=5146 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs	7821 Participants n=13115 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs	11272 Participants n=18261 Participants • Eligible patients who were prescribed dabigatran and warfarin as the first OACs
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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).

Incidence rate of stroke and systemic embolism (SE).

Outcome measures

Outcome measures
Measure	Dabigatran n=4606 Participants Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.	Warfarin n=4606 Participants Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Incidence Rate of Stroke and Systemic Embolism (SE)	2.898 per patient-year	3.563 per patient-year

SECONDARY outcome

Timeframe: 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).

Incidence rate of major bleeding defined by any bleeding event associated with hospitalization claims and/or transfusion claims.

Outcome measures

Outcome measures
Measure	Dabigatran n=4606 Participants Patients prescribed dabigatran as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.	Warfarin n=4606 Participants Patients prescribed warfarin as the first Oral Anticoagulants (OACs) with nonvalvular atrial fibrillation.
Incidence Rate of Major Bleeding	0.639 per patient-year	1.128 per patient-year

Adverse Events

Dabigatran

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warfarin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place