Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of asian patients with atrial fibrillation

So Ryoung Lee, Young Soo Lee, Ji Suck Park, Myung Jin Cha, Tae Hoon Kim, Junbeom Park, Jin Kyu Park, Jung Myung Lee, Ki Woon Kang, Jaemin Shim, Jae Sun Uhm, Jun Kim, Changsoo Kim, Jin Bae Kim, Hyung Wook Park, Boyoung Joung, Eue Keun Choi

Research output: Contribution to journalArticle

Abstract

Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. Materials and Methods: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on-or off-label use according to Korea Food and Drug Regulations. Results: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA 2 DS 2 -VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. Conclusion: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.

Original languageEnglish
Pages (from-to)277-284
Number of pages8
JournalYonsei medical journal
Volume60
Issue number3
DOIs
Publication statusPublished - 2019 Mar

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Anticoagulants
Atrial Fibrillation
Drug and Narcotic Control
Stroke
Prescriptions
Off-Label Use
Korea
Population
Registries
Creatinine
Blood Platelets
Body Weight
Hemorrhage
Hypertension
Kidney
Food

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Lee, So Ryoung ; Lee, Young Soo ; Park, Ji Suck ; Cha, Myung Jin ; Kim, Tae Hoon ; Park, Junbeom ; Park, Jin Kyu ; Lee, Jung Myung ; Kang, Ki Woon ; Shim, Jaemin ; Uhm, Jae Sun ; Kim, Jun ; Kim, Changsoo ; Kim, Jin Bae ; Park, Hyung Wook ; Joung, Boyoung ; Choi, Eue Keun. / Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of asian patients with atrial fibrillation. In: Yonsei medical journal. 2019 ; Vol. 60, No. 3. pp. 277-284.
@article{c9fbdbbfee154383aeba65a9077cf7c5,
title = "Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of asian patients with atrial fibrillation",
abstract = "Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. Materials and Methods: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on-or off-label use according to Korea Food and Drug Regulations. Results: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2{\%}, rivaroxaban 23.9{\%}, apixaban 36.9{\%}, and edoxaban 12.0{\%}). The mean age was 70.5±9.2 years; 56.0{\%} were men; and the mean CHA 2 DS 2 -VASc score was 3.3±1.4. Only one-third of the patients (32.7{\%}) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4{\%}) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. Conclusion: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.",
author = "Lee, {So Ryoung} and Lee, {Young Soo} and Park, {Ji Suck} and Cha, {Myung Jin} and Kim, {Tae Hoon} and Junbeom Park and Park, {Jin Kyu} and Lee, {Jung Myung} and Kang, {Ki Woon} and Jaemin Shim and Uhm, {Jae Sun} and Jun Kim and Changsoo Kim and Kim, {Jin Bae} and Park, {Hyung Wook} and Boyoung Joung and Choi, {Eue Keun}",
year = "2019",
month = "3",
doi = "10.3349/ymj.2019.60.3.277",
language = "English",
volume = "60",
pages = "277--284",
journal = "Yonsei Medical Journal",
issn = "0513-5796",
publisher = "Yonsei University College of Medicine",
number = "3",

}

Lee, SR, Lee, YS, Park, JS, Cha, MJ, Kim, TH, Park, J, Park, JK, Lee, JM, Kang, KW, Shim, J, Uhm, JS, Kim, J, Kim, C, Kim, JB, Park, HW, Joung, B & Choi, EK 2019, 'Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of asian patients with atrial fibrillation', Yonsei medical journal, vol. 60, no. 3, pp. 277-284. https://doi.org/10.3349/ymj.2019.60.3.277

Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of asian patients with atrial fibrillation. / Lee, So Ryoung; Lee, Young Soo; Park, Ji Suck; Cha, Myung Jin; Kim, Tae Hoon; Park, Junbeom; Park, Jin Kyu; Lee, Jung Myung; Kang, Ki Woon; Shim, Jaemin; Uhm, Jae Sun; Kim, Jun; Kim, Changsoo; Kim, Jin Bae; Park, Hyung Wook; Joung, Boyoung; Choi, Eue Keun.

In: Yonsei medical journal, Vol. 60, No. 3, 03.2019, p. 277-284.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of asian patients with atrial fibrillation

AU - Lee, So Ryoung

AU - Lee, Young Soo

AU - Park, Ji Suck

AU - Cha, Myung Jin

AU - Kim, Tae Hoon

AU - Park, Junbeom

AU - Park, Jin Kyu

AU - Lee, Jung Myung

AU - Kang, Ki Woon

AU - Shim, Jaemin

AU - Uhm, Jae Sun

AU - Kim, Jun

AU - Kim, Changsoo

AU - Kim, Jin Bae

AU - Park, Hyung Wook

AU - Joung, Boyoung

AU - Choi, Eue Keun

PY - 2019/3

Y1 - 2019/3

N2 - Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. Materials and Methods: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on-or off-label use according to Korea Food and Drug Regulations. Results: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA 2 DS 2 -VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. Conclusion: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.

AB - Purpose: Label adherence for non-vitamin K antagonist oral anticoagulants (NOACs) has not been well evaluated in Asian patients with non-valvular atrial fibrillation (AF). The present study aimed to assess label adherence for NOACs in a Korean AF population and to determine risk factors of off-label prescriptions of NOACs. Materials and Methods: In this COmparison study of Drugs for symptom control and complication prEvention of AF (CODE-AF) registry, patients with AF who were prescribed NOACs between June 2016 and May 2017 were included. Four NOAC doses were categorized as on-or off-label use according to Korea Food and Drug Regulations. Results: We evaluated 3080 AF patients treated with NOACs (dabigatran 27.2%, rivaroxaban 23.9%, apixaban 36.9%, and edoxaban 12.0%). The mean age was 70.5±9.2 years; 56.0% were men; and the mean CHA 2 DS 2 -VASc score was 3.3±1.4. Only one-third of the patients (32.7%) was prescribed a standard dose of NOAC. More than one-third of the study population (n=1122, 36.4%) was prescribed an off-label reduced dose of NOAC. Compared to those with an on-label standard dosing, patients with an off-label reduced dose of NOAC were older (≥75 years), women, and had a lower body weight (≤60 kg), renal dysfunction (creatinine clearance ≤50 mL/min), previous stroke, previous bleeding, hypertension, concomitant dronedarone use, and anti-platelet use. Conclusion: In real-world practice, more than one-third of patients with NOAC prescriptions received an off-label reduced dose, which could result in an increased risk of stroke. Considering the high risk of stroke in these patients, on-label use of NOAC is recommended.

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