Efficacy and safety of edoxaban tosylate hydrate 15 mg in the prevention of venous thromboembolism in patients with impaired renal function after orthopedic surgery of the lower extremities

Abstract

Abstract Background Although not indicated in the USA, edoxaban tosylate hydrate 15 mg is used for venous thromboembolism (VTE) prophylaxis after orthopedic surgery of the lower extremities in Japan. However, its efficacy and safety in patients with impaired renal function have not been fully evaluated. We aimed to investigate the intervention’s effectiveness in these patients. Methods From 2018 to 2020, patients who underwent total hip arthroplasty, total knee arthroplasty, hip fracture surgery, or knee arthroplasty single granule replacement and with renal dysfunction were evaluated. Safety was evaluated according to bleeding occurrence during edoxaban treatment and liver function endpoints. Patients were divided into the 15- and 30-mg oral groups, including 23 patients with impaired renal function and 209 with normal renal function, respectively. Results VTE incidence in the 15- and 30-mg groups was 8.7% and 8.6%, respectively; the intergroup difference was insignificant (odds ratio [OR] 0.99; 95% confidence interval [CI] 0.22–4.56; p = 1.00). Bleeding did not occur in the 15-mg group and was noted in 9 patients in the 30-mg group during treatment with edoxaban; the intergroup difference was insignificant (p = 1.00). The increase in aspartate aminotransferase and alanine aminotransferase levels was 30% in the 15-mg group and 19% in the 30-mg group, with no difference between the groups (p = 0.27). Multivariate analysis showed that the dose of edoxaban was not a significant factor associated with the incidence of VTE (adjusted OR 2.31; 95% CI 0.39–13.8; p = 0.36). Conclusions Edoxaban 15 mg in patients with impaired renal function may be as effective as edoxaban 30 mg in patients with normal renal function. However, the number of cases included in this study was small and the power was insufficient; therefore, a study with a larger sample size is desirable.