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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice.
The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban |
| |
| Vitamin K antagonist (VKA) | Patients who initiated OAC treatment with VKA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | 15/20 mg |
| |
| Vitamin K antagonist (VKA) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke or systemic embolism (SSE) | Retrospective analysis from January 1, 2011 to December 31, 2017 | |
| Major bleeding | Without access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithm | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhagic stroke | Retrospective analysis from January 1, 2011 to December 31, 2017 | |
| Ischemic stroke | Retrospective analysis from January 1, 2011 to December 31, 2017 | |
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Inclusion Criteria:
Exclusion Criteria:
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The source population of this study will be all the insured individuals included in the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases (Truven MarketScan).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases | Multiple Locations | Washington | 20001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31392894 | Result | Coleman CI, Kreutz R, Sood N, Bunz TJ, Meinecke AK, Eriksson D, Baker WL. Rivaroxaban's Impact on Renal Decline in Patients With Nonvalvular Atrial Fibrillation: A US MarketScan Claims Database Analysis. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619868535. doi: 10.1177/1076029619868535. | |
| 30597611 | Result |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Drug |
Individually adjusted dose |
|
| Subtypes of major bleeding |
| Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs) | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Acute kidney injury | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Renal impairment | Retrospective analysis from January 1, 2011 to December 31, 2017 |
| Martinez BK, Baker WL, Sood NA, Bunz TJ, Meinecke AK, Eriksson D, Coleman CI. Influence of Polypharmacy on the Effectiveness and Safety of Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation. Pharmacotherapy. 2019 Feb;39(2):196-203. doi: 10.1002/phar.2213. Epub 2019 Jan 28. |
| 31099460 | Result | Baker WL, Beyer-Westendorf J, Bunz TJ, Eriksson D, Meinecke AK, Sood NA, Coleman CI. Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes. Diabetes Obes Metab. 2019 Sep;21(9):2107-2114. doi: 10.1111/dom.13787. Epub 2019 Jun 11. |
| 31432074 | Result | Hernandez AV, Bradley G, Khan M, Fratoni A, Gasparini A, Roman YM, Bunz TJ, Eriksson D, Meinecke AK, Coleman CI. Rivaroxaban vs. warfarin and renal outcomes in non-valvular atrial fibrillation patients with diabetes. Eur Heart J Qual Care Clin Outcomes. 2020 Oct 1;6(4):301-307. doi: 10.1093/ehjqcco/qcz047. |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |