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

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT02061748

1160.192

Details and patient eligibility

About

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.

Full description

Study Design:

n/a

Enrollment: 38,499 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

38,499 participants in 2 patient groups

dabigatran

Treatment:

Drug: Observational

warfarin