Key result
Among patients not meeting criteria for dose reduction, receiving edoxaban 30 mg daily was associated with a higher rate of VTE recurrence or major bleeding compared to 60 mg (HR 8.37; 95% CI 1.12-42.4).
Why the study?
Edoxaban is used for VTE treatment, but real-life data about its efficacy and safety in long-term therapy are lacking.
Does the dose of edoxaban (60 mg vs 30 mg) affect the composite of VTE recurrences or major bleeding in patients with VTE on long-term therapy?
Cohort (n=562)
Does the dose of edoxaban (60 mg vs 30 mg) affect the composite of VTE recurrences or major bleeding in patients with VTE on long-term therapy?
Hazard Ratio: 8.37 (95% CI 1.12–42.4)
In real-world VTE patients, inappropriate dose reduction of edoxaban to 30 mg in those not meeting criteria is associated with significantly higher risks of recurrent VTE, major bleeding, and mortality.
Real-world edoxaban use for long-term VTE appears acceptable; leaves open whether dose-reduction criteria need revision.
Edoxaban is used for venous thromboembolism (VTE) treatment. Real-life data are lacking about its use in long-term therapy. We aimed to assess the efficacy and the safety of edoxaban for long-term VTE treatment in a real-life setting. Patients with VTE included in the Registro Informatizado Enfermedad TromboEmbólica (RIETE) registry, receiving edoxaban 60 or 30 mg daily were prospectively followed up to validate the benefit of using different dosages. The main outcome was the composite of VTE recurrences or major bleeding in patients with or without criteria for dose reduction. Multivariable analysis to identify predictors for the composite outcome was performed. From October 2015 to November 2019, 562 patients received edoxaban for long-term therapy. Most (94%) of the 416 patients not meeting criteria for dose reduction received 60 mg daily, and 92 patients meeting criteria (63%) received 30 mg daily. During treatment, two patients developed recurrent VTE, six had major bleeding and nine died (2 from fatal bleeding). Among patients not meeting criteria for dose reduction, those receiving 30 mg daily had a higher rate of the composite event (hazard ratio (HR) 8.37; 95% confidence interval (CI) 1.12-42.4) and a significant higher mortality rate (HR 31.1; 95% CI 4.63-262) than those receiving 60 mg. Among patients meeting criteria for dose reduction, those receiving 60 mg daily had no events, and a nonsignificantly higher mortality rate (HR 5.04; 95% CI 0.54-133) than those receiving 30 mg daily. In conclusion, edoxaban seems to be effective and safe for long-term VTE treatment in real life. Criteria for dose reduction should be reformulated.
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Camporese et al. (2020) conducted a cohort in venous thromboembolism (VTE) (n=562). Edoxaban 30 mg daily vs. Edoxaban 60 mg daily was evaluated on composite of VTE recurrences or major bleeding (HR 8.37, 95% CI 1.12-42.4). Among patients not meeting criteria for dose reduction, receiving edoxaban 30 mg daily was associated with a higher rate of VTE recurrence or major bleeding compared to 60 mg (HR 8.37; 95% CI 1.12-42.4).
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