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Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Weighing ≥ 120 Kilograms versus 60–120 Kilograms

Background Direct oral anticoagulants (DOACs) have become favorable choices for anticoagulation due to their fixed-dose schedule, limited need for monitoring, and non-inferiority or superiority to warfarin. DOACs are currently not recommended in patients with a body weight ≥ 120 kg or body mass inde...

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Published in:American journal of cardiovascular drugs : drugs, devices, and other interventions devices, and other interventions, 2021-09, Vol.21 (5), p.545-551
Main Authors: Wiethorn, Eryne E., Bell, Carolyn Magee, Wiggins, Barbara S.
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description Background Direct oral anticoagulants (DOACs) have become favorable choices for anticoagulation due to their fixed-dose schedule, limited need for monitoring, and non-inferiority or superiority to warfarin. DOACs are currently not recommended in patients with a body weight ≥ 120 kg or body mass index ≥ 40 kg/m 2 due to limited data regarding safety and efficacy. Objective The aim of this study was to compare the safety and efficacy of DOACs in patients with nonvalvular atrial fibrillation (NVAF) and weighing ≥ 120 kg with those weighing
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DOACs are currently not recommended in patients with a body weight ≥ 120 kg or body mass index ≥ 40 kg/m 2 due to limited data regarding safety and efficacy. Objective The aim of this study was to compare the safety and efficacy of DOACs in patients with nonvalvular atrial fibrillation (NVAF) and weighing ≥ 120 kg with those weighing &lt; 120 kg. Methods A single-center, retrospective study was conducted in patients weighing ≥ 120 kg who received either apixaban, dabigatran, or rivaroxaban for stroke risk reduction in NVAF, and matched to patients who weighed &lt; 120 kg. The primary outcome was the incidence of stroke, deep vein thrombosis, pulmonary embolism, or myocardial infarction, while the safety outcome was the incidence of major or clinically relevant non-major bleeding based on the International Society on Thrombosis and Haemostasis (ISTH) definitions. Results A total of 318 patients weighing ≥ 120 kg with NVAF and meeting the inclusion criteria were evaluated and matched with 318 patients weighing &lt; 120 kg. The primary outcome occurred in 2.5% of patients in the ≥ 120 kg group and in 3.1% of patients in the &lt; 120 kg group ( p  = 0.632). The safety outcome occurred in 5.3% and 6.6% of patients in these respective groups ( p  = 0.503). Conclusion Apixaban, dabigatran, or rivaroxaban may be well-tolerated and effective anticoagulant options in patients with NVAF weighing ≥ 120 kg.</description><identifier>ISSN: 1175-3277</identifier><identifier>EISSN: 1179-187X</identifier><identifier>DOI: 10.1007/s40256-021-00470-0</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Age ; Anticoagulants ; Body mass index ; Cardiac arrhythmia ; Cardiology ; Clinical trials ; Drug dosages ; Ethnicity ; Heart attacks ; Hospitals ; Medicine ; Medicine &amp; Public Health ; Original Research Article ; Patients ; Pharmacology/Toxicology ; Pharmacotherapy ; Pulmonary embolisms ; Stroke ; Thrombosis ; Veins &amp; arteries</subject><ispartof>American journal of cardiovascular drugs : drugs, devices, and other interventions, 2021-09, Vol.21 (5), p.545-551</ispartof><rights>The Author(s), under exclusive licence to Springer Nature Switzerland AG part of Springer Nature 2021</rights><rights>Copyright Springer Nature B.V. Sep 2021</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-7cf7a6610265ebb2edbf988ae2661a14f8b9661ee2fd0d6dae711b56bc5f69413</citedby><cites>FETCH-LOGICAL-c375t-7cf7a6610265ebb2edbf988ae2661a14f8b9661ee2fd0d6dae711b56bc5f69413</cites><orcidid>0000-0002-4184-8505 ; 0000-0003-4988-7485 ; 0000-0001-7024-9934</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,777,781,27905,27906</link.rule.ids></links><search><creatorcontrib>Wiethorn, Eryne E.</creatorcontrib><creatorcontrib>Bell, Carolyn Magee</creatorcontrib><creatorcontrib>Wiggins, Barbara S.</creatorcontrib><title>Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Weighing ≥ 120 Kilograms versus 60–120 Kilograms</title><title>American journal of cardiovascular drugs : drugs, devices, and other interventions</title><addtitle>Am J Cardiovasc Drugs</addtitle><description>Background Direct oral anticoagulants (DOACs) have become favorable choices for anticoagulation due to their fixed-dose schedule, limited need for monitoring, and non-inferiority or superiority to warfarin. DOACs are currently not recommended in patients with a body weight ≥ 120 kg or body mass index ≥ 40 kg/m 2 due to limited data regarding safety and efficacy. Objective The aim of this study was to compare the safety and efficacy of DOACs in patients with nonvalvular atrial fibrillation (NVAF) and weighing ≥ 120 kg with those weighing &lt; 120 kg. Methods A single-center, retrospective study was conducted in patients weighing ≥ 120 kg who received either apixaban, dabigatran, or rivaroxaban for stroke risk reduction in NVAF, and matched to patients who weighed &lt; 120 kg. The primary outcome was the incidence of stroke, deep vein thrombosis, pulmonary embolism, or myocardial infarction, while the safety outcome was the incidence of major or clinically relevant non-major bleeding based on the International Society on Thrombosis and Haemostasis (ISTH) definitions. Results A total of 318 patients weighing ≥ 120 kg with NVAF and meeting the inclusion criteria were evaluated and matched with 318 patients weighing &lt; 120 kg. The primary outcome occurred in 2.5% of patients in the ≥ 120 kg group and in 3.1% of patients in the &lt; 120 kg group ( p  = 0.632). The safety outcome occurred in 5.3% and 6.6% of patients in these respective groups ( p  = 0.503). Conclusion Apixaban, dabigatran, or rivaroxaban may be well-tolerated and effective anticoagulant options in patients with NVAF weighing ≥ 120 kg.</description><subject>Age</subject><subject>Anticoagulants</subject><subject>Body mass index</subject><subject>Cardiac arrhythmia</subject><subject>Cardiology</subject><subject>Clinical trials</subject><subject>Drug dosages</subject><subject>Ethnicity</subject><subject>Heart attacks</subject><subject>Hospitals</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Original Research Article</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacotherapy</subject><subject>Pulmonary embolisms</subject><subject>Stroke</subject><subject>Thrombosis</subject><subject>Veins &amp; arteries</subject><issn>1175-3277</issn><issn>1179-187X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kbtOwzAUhiMEEtcXYLLEHDh2E7sZq1IuAgESINgsJzkORqlTbLeIjZWZF2DhxXgS3BYJsTD5l__LGb4k2aWwTwHEgc-A5TwFRlOATEAKK8kGpaJIaV_cry50nvaYEOvJpvePAFQwUWwkHyOtsQpmhha9J8rW5FppDC-k0-TQuOiRS6daMrDBVJ1qpq2ywRNjyZUKBuf62YQHctHZmWpn0XZkEJyJlSNTOtO2MdbZxfIdmubB2IZ8vX0SyoCcmbZrnBp7MkPnp55w-Hp9_-NsJ2tatR53ft6t5PZodDM8Sc8vj0-Hg_O06ok8pKLSQnFOgfEcy5JhXeqi31fI4qeime6XRVSITNdQ81qhoLTMeVnlmhcZ7W0le8vdieuepuiDfOymzsaTkuUiy3jG-DzFlqnKdd471HLizFi5F0lBzknIJQkZScgFCQmx1FuWfAzbBt3v9D-tb7Oej2M</recordid><startdate>20210901</startdate><enddate>20210901</enddate><creator>Wiethorn, Eryne E.</creator><creator>Bell, Carolyn Magee</creator><creator>Wiggins, Barbara S.</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>4T-</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><orcidid>https://orcid.org/0000-0002-4184-8505</orcidid><orcidid>https://orcid.org/0000-0003-4988-7485</orcidid><orcidid>https://orcid.org/0000-0001-7024-9934</orcidid></search><sort><creationdate>20210901</creationdate><title>Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Weighing ≥ 120 Kilograms versus 60–120 Kilograms</title><author>Wiethorn, Eryne E. ; 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DOACs are currently not recommended in patients with a body weight ≥ 120 kg or body mass index ≥ 40 kg/m 2 due to limited data regarding safety and efficacy. Objective The aim of this study was to compare the safety and efficacy of DOACs in patients with nonvalvular atrial fibrillation (NVAF) and weighing ≥ 120 kg with those weighing &lt; 120 kg. Methods A single-center, retrospective study was conducted in patients weighing ≥ 120 kg who received either apixaban, dabigatran, or rivaroxaban for stroke risk reduction in NVAF, and matched to patients who weighed &lt; 120 kg. The primary outcome was the incidence of stroke, deep vein thrombosis, pulmonary embolism, or myocardial infarction, while the safety outcome was the incidence of major or clinically relevant non-major bleeding based on the International Society on Thrombosis and Haemostasis (ISTH) definitions. Results A total of 318 patients weighing ≥ 120 kg with NVAF and meeting the inclusion criteria were evaluated and matched with 318 patients weighing &lt; 120 kg. The primary outcome occurred in 2.5% of patients in the ≥ 120 kg group and in 3.1% of patients in the &lt; 120 kg group ( p  = 0.632). The safety outcome occurred in 5.3% and 6.6% of patients in these respective groups ( p  = 0.503). Conclusion Apixaban, dabigatran, or rivaroxaban may be well-tolerated and effective anticoagulant options in patients with NVAF weighing ≥ 120 kg.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><doi>10.1007/s40256-021-00470-0</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-4184-8505</orcidid><orcidid>https://orcid.org/0000-0003-4988-7485</orcidid><orcidid>https://orcid.org/0000-0001-7024-9934</orcidid></addata></record>
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subjects Age
Anticoagulants
Body mass index
Cardiac arrhythmia
Cardiology
Clinical trials
Drug dosages
Ethnicity
Heart attacks
Hospitals
Medicine
Medicine & Public Health
Original Research Article
Patients
Pharmacology/Toxicology
Pharmacotherapy
Pulmonary embolisms
Stroke
Thrombosis
Veins & arteries
title Effectiveness and Safety of Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Weighing ≥ 120 Kilograms versus 60–120 Kilograms
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