期刊名称：Journal of Clinical Biochemistry and Nutrition
印刷版ISSN：0912-0009
电子版ISSN：1880-5086
出版年度：2021
卷号：69
期号：3
页码：311-316
DOI：10.3164/jcbn.21-9
语种：English
出版社：The Society for Free Radical Research Japan
摘要：In clinical practice, edoxaban is sometimes prescribed for off-label use based on the hypothesis that it is as safe and effective as warfarin. However, there is limited safety information on
off-label use due to lack of clinical trial. We aimed to analyze the tolerability of
off-label use of edoxaban and to identify patient characteristics associated with major bleeding as adverse effects. Patients under edoxaban treatment between January 2017 and December 2017 were enrolled in this retrospective cohort study. The incidence of major bleeding with
off-label use compared with on-label use was analyzed using by log-rank test. Univariate and multivariate regression analysis were undertaken to detect independent variables with significant odds ratio that associated with major bleeding. After the exclusion criteria were applied, the patients were divided into two groups:
off-label group (
n = 30) and on-label group (
n = 161). Incidence of major bleeding was found to be higher in the
off-label group (13.3%) than in the
on-label group (3.7%) (
p<0.05). Multivariate adjustment showed that the
off-label use or portal vein thrombosis and patients with history of major bleeding has significantly higher incidence of major bleeding. We demonstrated that
off-label use of edoxaban may be a significant risk factor for major bleeding.
