Key result
Super low-dose edoxaban linked to a ~4% recurrent VTE rate, exceeding 30mg and 60mg doses.
Why the study?
The effectiveness and safety of edoxaban for venous thromboembolism in unselected real-world patients have not been fully evaluated.
Does the dose of edoxaban affect the risk of recurrent VTE and bleeding in real-world patients with venous thromboembolism?
Cohort (n=6,262)
Yes
Does the dose of edoxaban affect the risk of recurrent VTE and bleeding in real-world patients with venous thromboembolism?
Absolute Event Rate: 4.4% vs 2.6%
In real-world practice, patients receiving a super low dose (15 mg) of edoxaban for VTE are older, weigh less, and experience higher rates of both recurrent VTE and bleeding compared to those on higher doses.
Super-low-dose edoxaban may elevate recurrence and bleeding risks in frail real-world VTE patients; leaves optimal dosing open for prospective trials.
BACKGROUND: The effectiveness and safety of edoxaban for venous thromboembolism (VTE) in unselected real-world patients have not been fully evaluated. METHODS AND RESULTS: In the Japanese nationwide administrative database, we identified 6,262 VTE patients in whom edoxaban was initiated; these patients were divided into 3 groups based on their index doses: 15 mg/day (n=235), 30 mg/day (n=4,532), and 60 mg/day (n=1,495). We evaluated patient characteristics, recurrent VTEs, and a composite endpoint of intracranial hemorrhage (ICH) and gastrointestinal (GI) bleeding. Patient characteristics among the 15-, 30-, and 60-mg edoxaban groups varied widely regarding several aspects, including age (mean 81.0, 76.2, and 65.0 years, respectively) and body weight (mean 49.5, 51.8, and 70.3 kg, respectively). At 180 days, the cumulative incidence of recurrent VTEs in the 15-, 30-, and 60-mg edoxaban groups was 4.4%, 2.6%, and 1.8%, respectively, whereas that of ICH or GI bleeding was 7.3%, 5.4%, and 3.3%, respectively. Subgroup analyses showed that the cumulative incidence of ICH or GI bleeding in patients in the 15-mg edoxaban group was 3.6% for patients aged ≥80 years, 8.4% for those with a body weight <60 kg, and 31.3% for those with renal dysfunction. CONCLUSIONS: Only a minority of patients with VTEs received a super low dose (15 mg) of edoxaban, and these patients may be at higher risk of bleeding as well as VTE recurrence.
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Yamashita et al. (2023) conducted a cohort in Venous thromboembolism (n=6,262). Edoxaban vs. Other edoxaban dose groups (30 mg and 60 mg) was evaluated on Recurrent VTE at 180 days. Patients receiving a super low dose (15 mg) of edoxaban for venous thromboembolism had a 180-day cumulative incidence of recurrent VTE of 4.4%, compared to 2.6% and 1.8% in those receiving 30 mg and 60 mg, respectively.
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