The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38499 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-28

Study Completion Date

2016-03-15

Brief Summary

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This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.

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Detailed Description

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Study Design:

n/a

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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dabigatran

Observational

Intervention Type DRUG

Retrospective Chart Review

warfarin

No interventions assigned to this group

Interventions

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Observational

Retrospective Chart Review

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient must have at least one inpatient, one physician office visit, or one emergency room visit with a diagnosis of AF on the index date or during the pre-index period.
* Patients must be continuously enrolled in a health plan during the pre-index period
* Patient must have a prescription for dabigatran or warfarin
* Patient must be treatment naive from all oral anticoagulant (OAC) use prior to first OAC prescription
* Aged 18-89 years on the index date. The index date is defined as the date of the first OAC prescription

Exclusion Criteria

* Diagnosis of hyperthyroidism during the pre-index period,
* Having claims for any of the following within 3 months prior to the first diagnosis of AF: cardiac surgery, pericarditis, myocarditis, pulmonary embolism.
* Any patients with at least one medical claim for valvular heart disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No