Key result
Edoxaban 15 mg once daily was well tolerated, with major or clinically relevant non-major bleeding occurring in 3.4% of patients with severe renal impairment, compared to 6.7% with edoxaban 30 mg in mild renal impairment and 5.0% with fondaparinux.
Why the study?
Does edoxaban 15 mg once daily provide safe thromboembolic prophylaxis in Japanese patients with severe renal impairment undergoing lower-limb orthopedic surgery?
RCT (n=80)
Open-label
Randomized (for patients with CL CR ≥20 to <30 mL/min)
Yes
Does edoxaban 15 mg once daily provide safe thromboembolic prophylaxis in Japanese patients with severe renal impairment undergoing lower-limb orthopedic surgery?
Edoxaban 15 mg once daily appears safe and well-tolerated for thromboembolic prophylaxis in Japanese patients with severe renal impairment undergoing lower-limb orthopedic surgery.
Supports reduced-dose edoxaban for VTE prophylaxis in severe renal impairment; extends RCT safety data to Japanese orthopedic patients.
BACKGROUND: Edoxaban is an oral, direct, factor Xa inhibitor approved in Japan for thromboembolic prophylaxis after lower-limb orthopedic surgery (LLOS), but contraindicated in patients with severe renal impairment (SRI; creatinine clearance [CLCR] ≥15 to <30 mL/min). METHODS: This open-label study compared the safety of edoxaban 15 mg once daily in Japanese patients with SRI to that of edoxaban 30 mg in patients with mild renal impairment (MiRI; CLCR ≥50 to ≤80 mL/min; N = 30) undergoing LLOS. Patients with CLCR ≥20 to <30 mL/min were randomized to receive edoxaban 15 mg (N = 22) or subcutaneous fondaparinux 1.5 mg once daily (N = 21). All patients with CLCR ≥15 to <20 mL/min received edoxaban 15 mg (N = 7). Treatment was administered for 11 to 14 days. RESULTS: Major or clinically relevant non-major bleeding occurred in 6.7%, 3.4%, and 5.0% of patients in the MiRI edoxaban 30-mg, SRI edoxaban 15-mg, and SRI fondaparinux groups, respectively; there were no major bleeding events. No thromboembolic events occurred. At all time points assessed, edoxaban plasma concentrations and changes in coagulation biomarkers were similar between the SRI and MiRI groups. CONCLUSIONS: These results suggest edoxaban 15 mg once daily is well tolerated in Japanese patients with SRI undergoing LLOS. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01857583.
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Fuji et al. (2015) conducted an RCT in Severe renal impairment undergoing lower-limb orthopedic surgery (n=80). Edoxaban vs. Edoxaban 30 mg once daily (for mild renal impairment) or fondaparinux 1.5 mg once daily was evaluated on Major or clinically relevant non-major (CRNM) bleeding (absolute difference 3.2%, 95% CI -11.3, 18.1). Edoxaban 15 mg once daily was well tolerated, with major or clinically relevant non-major bleeding occurring in 3.4% of patients with severe renal impairment, compared to 6.7% with edoxaban 30 mg in mild renal impairment and 5.0% with fondaparinux.
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