PB0460 - Clinical effectiveness and safety of edoxaban in obese patients - Results of the Prospective DRESDEN NOAC REGISTRY (NCT01588119)

Background: Edoxaban, a direct acting non-Vitamin K antagonist oral anticoagulant (NOAC), is approved for stroke prevention in atrial fibrillation and for treatment of venous thromboembolism. Edoxaban is given at a dose of 30 or 60 mg once daily, irrespective of the body weight of patients. However, edoxaban has a large volume of distribution, potentially increasing the risk of under-exposure in obese patients. Current guidance recommends preference of apixaban or rivaroxaban for obese patients, also because data on the clinical effectiveness and safety of edoxaban in this population are scarce.

Aims: To collect more data on the clinical impact of overweight on edoxaban treatment outcomes.

Methods: From the ongoing non-interventional Dresden NOAC Registry we categorized patients with edoxaban treatment into different body mass index (BMI) categories and evaluated cardiovascular (CV), major bleeding events (MB) and all-cause mortality for each BMI class. All outcome events were centrally adjudicated using standard scientific definitions.

Results: Between November 1st 2011 and May 31st 2022, 5212 patients were enrolled into the registry, including 1707 patients with edoxaban treatment (table 1). For this subset, mean follow-up was 949.5±562.1 days and mean exposure time to edoxaban was 710.3±575.7 days. With increasing BMI (range 15.6-69.7 kg/m2), the use of edoxaban 60 mg (compared to 30 mg) once daily increased from 28.6% (BMI 15.6-18.2 kg/m2) to 79.2% (BMI 40.0-69.7 kg/m²). Although the frequency of hypertension and diabetes as important cardiovascular and bleeding risk factors increased with rising BMI, rates of major thromboembolic events and rates of major bleeding were not different in overweight and obese patients compared to normal weight patients (Table 2).

Conclusion(s): Our data support the use of edoxaban also in patients with high BMI, since we found no indication that high body mass leads to underexposure or higher rates of thromboembolic events.