Label Adherence for Non-Vitamin K Antagonist Oral Anticoagulants in a Prospective Cohort of Asian Patients with Atrial Fibrillation
Yonsei Medical Journal
;
: 277-284, 2019.
Article
in English
| WPRIM
| ID: wpr-742534
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 ANDMETHODS:
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.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Atrial Fibrillation
/
Body Weight
/
Prospective Studies
/
Risk Factors
/
Cohort Studies
/
Stroke
/
Asian People
/
Drug and Narcotic Control
/
Drug Labeling
/
Prescriptions
Type of study:
Etiology study
/
Incidence study
/
Observational study
/
Risk factors
Limits:
Female
/
Humans
/
Male
Country/Region as subject:
Asia
Language:
English
Journal:
Yonsei Medical Journal
Year:
2019
Type:
Article
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