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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 Par  ;  Boyoung Joung  ;  Eue-Keun Choi 
 YONSEI MEDICAL JOURNAL, Vol.60(3) : 277-284, 2019 
Journal Title
Issue Date
Administration, Oral ; Aged ; Anticoagulants/administration & dosage* ; Anticoagulants/therapeutic use* ; Asian Continental Ancestry Group* ; Atrial Fibrillation/complications ; Atrial Fibrillation/drug therapy* ; Dabigatran/administration & dosage ; Dabigatran/therapeutic use ; Drug Labeling* ; Female ; Humans ; Male ; Medication Adherence* ; Middle Aged ; Prospective Studies ; Pyrazoles/therapeutic use ; Pyridines/therapeutic use ; Pyridones/therapeutic use ; Republic of Korea ; Risk Factors ; Rivaroxaban/administration & dosage ; Rivaroxaban/therapeutic use ; Thiazoles/therapeutic use ; Vitamin K/antagonists & inhibitors*
Atrial fibrillation ; dose ; drug labeling ; non-vitamin K antagonist oral anticoagulant
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 CHA₂DS₂-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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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Uhm, Jae Sun(엄재선) ORCID logo https://orcid.org/0000-0002-1611-8172
Joung, Bo Young(정보영) ORCID logo https://orcid.org/0000-0001-9036-7225
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