Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
10.3349/ymj.2019.60.3.277
- Author:
So Ryoung LEE
1
;
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
Author Information
1. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. choiek17@snu.ac.kr
- Publication Type:Original Article
- Keywords:
Atrial fibrillation;
non-vitamin K antagonist oral anticoagulant;
drug labeling;
dose
- MeSH:
Anticoagulants;
Asian Continental Ancestry Group;
Atrial Fibrillation;
Body Weight;
Cohort Studies;
Drug and Narcotic Control;
Drug Labeling;
Female;
Hemorrhage;
Humans;
Hypertension;
Korea;
Male;
Off-Label Use;
Prescriptions;
Prospective Studies;
Risk Factors;
Rivaroxaban;
Stroke
- From:Yonsei Medical Journal
2019;60(3):277-284
- CountryRepublic of Korea
- Language:English
-
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 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.
