Key result
Edoxaban dosing was according to label in 87.6% of 1,635 real-world patients, with inadequate dosing more frequent in female, older, and transplant patients.
Why the study?
Edoxaban effectiveness and safety depend on adequate dosing, but real-world dosing pattern data outside of clinical trials are scarce.
Observational (n=1,635)
In real-world practice, edoxaban dosing is adequate in nearly 90% of patients, with renal impairment being the primary driver for dose reduction, though inadequate dosing is more common in older, female, and transplant patients.
Label-concordant edoxaban dosing predominates in real-world practice; supports broad use but leaves open outcome effects in high-risk subgroups.
Edoxaban is a non-vitamin K dependent oral anticoagulant (NOAC) licensed for venous thromboembolism treatment or stroke prevention in atrial fibrillation. Effectiveness and safety of edoxaban depends on adequate dosing, for which renal function, body weight and drug-drug interactions are important. Edoxaban dosing pattern data outside of clinical trials are scarce. Using data from the prospective DRESDEN NOAC REGISTRY we analysed dosing of 1635 edoxaban patients. Between January 2016 and May 2021, 1652 edoxaban treated patients were enrolled and 1635 patients included in the dosing analysis. At baseline, 1257 patients (76.9%) received edoxaban 60 mg daily, 378 patients (23.1%) 30 mg daily. Patients receiving edoxaban 60 mg were more often male, younger and less often had concomitant diseases such as cancer, renal impairment or organ transplantation. Edoxaban dosing was according to label in 1432 (87.6%) and not according to label in 203 patients (6.5% non-recommended 60 mg and 5.9% non-recommended 30 mg). Renal impairment was the dominating reason for dose adjustment, followed by body weight ≤60 kg. Edoxaban dosing was more often adequate in patients younger than 75 years and in male patients compared to older or female patients. Taken together, edoxaban dosing was adequate in up to 90% of patients, with renal impairment being the most important factor for dose reduction. Use of strong P-gp inhibitors was a rare finding and dose reduction was appropriately performed in the majority of these patients. Inadequate dosing seems more frequent in female or older patients and in transplant recipients, indicating areas for further research.
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Beyer‐Westendorf et al. (2021) conducted an observational in Patients requiring anticoagulation (venous thromboembolism or atrial fibrillation) (n=1,635). Edoxaban was evaluated on Edoxaban dosing according to label. Edoxaban dosing was according to label in 87.6% of 1,635 real-world patients, with inadequate dosing more frequent in female, older, and transplant patients.
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