All-Cause Mortality and Cardiovascular Outcomes with non-Vitamin K Oral Anticoagulants versus Warfarin in Patients with Heart Failure in the Food and Drug Administration Adverse Event Reporting System (FAERS)

Thomas von Lueder, Dan Atar, Stefan Agewall, Jesper K. Jensen, Ingrid Kate Hopper, Dipak Kotecha, Robert J. Mentz, Moo Hyun Kim, Victor Serebruany

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes.
Study Question: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Study Design: We extracted and examined outcome cases in subjects with HF and on warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban and stratified these according to anticoagulants.
Measures and Outcomes: Annual all-cause mortality, myocardial infarction, and stroke in FAERS.
Analysis Method: Odds ratio (OR) and x2x2 for oral anticoagulants from FAERS with and without HF among complete primary reports issued in 2015.
Original languageEnglish
Number of pages8
JournalAmerican Journal of Therapeutics
DOIs
Publication statusAccepted/In press - 24 May 2019

Cite this

@article{b7abcb0ae3624360be9b6f047c15a83a,
title = "All-Cause Mortality and Cardiovascular Outcomes with non-Vitamin K Oral Anticoagulants versus Warfarin in Patients with Heart Failure in the Food and Drug Administration Adverse Event Reporting System (FAERS)",
abstract = "Background: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes.Study Question: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Study Design: We extracted and examined outcome cases in subjects with HF and on warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban and stratified these according to anticoagulants. Measures and Outcomes: Annual all-cause mortality, myocardial infarction, and stroke in FAERS.Analysis Method: Odds ratio (OR) and x2x2 for oral anticoagulants from FAERS with and without HF among complete primary reports issued in 2015.",
author = "{von Lueder}, Thomas and Dan Atar and Stefan Agewall and Jensen, {Jesper K.} and Hopper, {Ingrid Kate} and Dipak Kotecha and Mentz, {Robert J.} and Kim, {Moo Hyun} and Victor Serebruany",
year = "2019",
month = "5",
day = "24",
doi = "10.1097/MJT.0000000000000883",
language = "English",
journal = "American Journal of Therapeutics",
issn = "1536-3686",
publisher = "Lippincott Williams & Wilkins",

}

All-Cause Mortality and Cardiovascular Outcomes with non-Vitamin K Oral Anticoagulants versus Warfarin in Patients with Heart Failure in the Food and Drug Administration Adverse Event Reporting System (FAERS). / von Lueder, Thomas; Atar, Dan; Agewall, Stefan; Jensen, Jesper K.; Hopper, Ingrid Kate; Kotecha, Dipak; Mentz, Robert J.; Kim, Moo Hyun; Serebruany, Victor.

In: American Journal of Therapeutics, 24.05.2019.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - All-Cause Mortality and Cardiovascular Outcomes with non-Vitamin K Oral Anticoagulants versus Warfarin in Patients with Heart Failure in the Food and Drug Administration Adverse Event Reporting System (FAERS)

AU - von Lueder, Thomas

AU - Atar, Dan

AU - Agewall, Stefan

AU - Jensen, Jesper K.

AU - Hopper, Ingrid Kate

AU - Kotecha, Dipak

AU - Mentz, Robert J.

AU - Kim, Moo Hyun

AU - Serebruany, Victor

PY - 2019/5/24

Y1 - 2019/5/24

N2 - Background: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes.Study Question: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Study Design: We extracted and examined outcome cases in subjects with HF and on warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban and stratified these according to anticoagulants. Measures and Outcomes: Annual all-cause mortality, myocardial infarction, and stroke in FAERS.Analysis Method: Odds ratio (OR) and x2x2 for oral anticoagulants from FAERS with and without HF among complete primary reports issued in 2015.

AB - Background: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes.Study Question: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.Study Design: We extracted and examined outcome cases in subjects with HF and on warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban and stratified these according to anticoagulants. Measures and Outcomes: Annual all-cause mortality, myocardial infarction, and stroke in FAERS.Analysis Method: Odds ratio (OR) and x2x2 for oral anticoagulants from FAERS with and without HF among complete primary reports issued in 2015.

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JO - American Journal of Therapeutics

JF - American Journal of Therapeutics

SN - 1536-3686

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