Association of risk factors and bleeding complications in Asian patients taking edoxaban

Aim: Asian patients are known to be more prone to bleeding complications than patients of other ethnicities. Therefore, there are possibilities of other risk factors that should be given special consideration for dosage adjustment in this specific ethnic group. This study aimed to investigate the risk factors for bleeding complications in Asian patients under appropriate edoxaban dosage regimens. Methods: Data on patients taking proper dosages, based on the Lixiana package insert, were analyzed. Univariate and multivariable analyses were conducted to evaluate associations between risk factors and bleeding outcomes. Subgroup analysis was performed on high-risk patients for bleeding complications whose edoxaban dose was reduced according to the package insert. Results: A total of 346 patients were included. Among them, 32 patients experienced bleeding complications. Patients with either weights of less than or equal to 60 kg and with cancer showed around 3.3- and 3.4-fold increased risk of bleeding complications compared to heavier patients ( > 60 kg) and those without cancer, respectively. In subgroup analysis with high-risk patients who took low-dose edoxaban (15 mg and 30 mg), weights of less than or equal to 60 kg remained a significant factor for bleeding outcomes. Conclusion: This study showed that weights of less than or equal to 60 kg and the presence of cancers could affect bleeding complications which occurred despite proper edoxaban treatment in Asian patients. Therefore, more strict dosage guideline could be considered in populations with high proportions of Asian ethnicities.