N/A
Completed N=38,499
The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage
Source: ClinicalTrials.gov NCT02061748 ↗Enrolled (actual)
38,499
Serious AEs
—
Results posted
Jun 2017
Primary outcomePrimary: Stroke (Primary Analysis) — 21.9; 29.3 Events per 1000 patient-years — p=0.0111
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stroke (Primary Analysis) |
21.9; 29.3 | 0.0111 sig |
| PRIMARY Stroke (Post-hoc Analysis) |
12.4; 16.1 | 0.0861 |
| PRIMARY Major Bleeding (Primary Analysis) |
61.7; 76.7 | 0.0011 sig |
| PRIMARY Major Bleeding (Post-hoc Analysis) |
35.6; 46.9 | 0.0019 sig |
| SECONDARY Ischemic Stroke (Primary Analysis) |
21.7; 26.4 | 0.0808 |
| SECONDARY Ischemic Stroke (Post-hoc Analysis) |
11.2; 12.9 | 0.3502 |
| SECONDARY Hemorrhagic Stroke (Primary Analysis) |
1.5; 4.4 | 0.0068 sig |
| SECONDARY Hemorrhagic Stroke (Post-hoc Analysis) |
1.2; 3.3 | 0.0271 sig |
| SECONDARY Major Intracranial Bleeding (Primary Analysis) |
8.0; 11.3 | 0.0749 |
| SECONDARY Major Intracranial Bleeding (Post-hoc Analysis) |
4.4; 8.6 | 0.0072 sig |
| SECONDARY Major Extracranial Bleeding (Primary Analysis) |
54.4; 66.1 | 0.0055 sig |
| SECONDARY Major Extracranial Bleeding (Post-hoc Analysis) |
31.2; 38.3 | 0.0284 sig |
| SECONDARY Major GI Bleeding (Primary Analysis) |
44.4; 44.0 | 0.907 |
| SECONDARY Major GI Bleeding (Post-hoc Analysis) |
28.5; 28.7 | 0.8208 |
| SECONDARY Major Upper GI Bleeding (Primary Analysis) |
6.6; 9.0 | 0.1534 |
| SECONDARY Major Upper GI Bleeding (Post-hoc Analysis) |
5.4; 6.8 | 0.3055 |
| SECONDARY Major Lower GI Bleeding (Primary Analysis) |
43.4; 42.8 | 0.9573 |
| SECONDARY Major Lower GI Bleeding (Post-hoc Analysis) |
23.6; 22.7 | 0.8465 |
| SECONDARY Major Urogenital Bleeding (Primary Analysis) |
5.8; 12.1 | 0.0006 sig |
| SECONDARY Major Urogenital Bleeding (Post-hoc Analysis) |
0.2; 4.5 | <0.0001 sig |
| SECONDARY Other Major Bleeds (Primary Analysis) |
12.7; 18.2 | 0.0185 sig |
| SECONDARY Other Major Bleeds (Post-hoc Analysis) |
2.7; 5.8 | 0.0138 sig |
| SECONDARY Transient Ischemic Attack (TIA) (Primary Analysis) |
10.7; 13.0 | 0.261 |
| SECONDARY TIA (Post-hoc Analysis) |
3.4; 4.4 | 0.4407 |
| SECONDARY Myocardial Infarction (MI) (Primary Analysis) |
13.6; 16.1 | 0.2665 |
| SECONDARY MI (Post-hoc Analysis) |
8.0; 7.5 | 0.8017 |
| SECONDARY Venous Thromboembolism (Primary Analysis) |
12.2; 23.0 | <0.0001 sig |
| SECONDARY Venous Thromboembolism (Post-hoc Analysis) |
2.2; 3.5 | 0.2083 |
| SECONDARY Deep Vein Thrombosis (Primary Analysis) |
9.5; 15.9 | 0.0023 sig |
| SECONDARY Deep Vein Thrombosis (Post-hoc Analysis) |
1.0; 1.3 | 0.5331 |
| SECONDARY Pulmonary Embolism (Primary Analysis) |
3.4; 9.1 | 0.0003 sig |
| SECONDARY Pulmonary Embolism (Post-hoc Analysis) |
1.2; 2.1 | 0.2646 |
| SECONDARY All-cause Death (Primary Analysis) |
36.6; 49.8 | 0.0004 sig |
| SECONDARY All-cause Death (Post-hoc Analysis) |
36.6; 49.8 | 0.0004 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02061748). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.