Comparative Effectiveness and Safety Between Warfarin and Dabigatran

Boehringer Ingelheim22,490 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

22,490

Conditions

Atrial Fibrillation

Interventions

WarfarinDRUG

patients treated with warfarin

DabigatranDRUG

patients treated with Dabigatran

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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