Real-world dosing patterns and outcomes of edoxaban in patients with non-valvular atrial fibrillation and type 2 diabetes mellitus: A gender perspective study

Background and aim Patients diagnosed with non-valvular atrial fibrillation (NVAF) often present with concomitant type 2 diabetes mellitus (T2DM), both conditions are associated with an increased risk of mortality due to cardiovascular complications such as stroke and heart failure. Given the observed gender differences not only in baseline characteristics but also in direct oral anticoagulant (DOACs) prescription patterns, the aim of the present study was to evaluate edoxaban dosing patterns and safety in men and women with both NVAF and T2DM in a real-world setting. Methods Patients with NVAF and T2DM undergoing treatment with edoxaban for 3–6 months prior to inclusion were enrolled in the FADIA study. This was an observational, real-world, prospective, single-cohort, multicentric study with a 12-month follow-up period after inclusion. Results Data from 204 patients were analysed: 92 women (45.1%) and 112 men (54.9%). Women were older, had worse renal function compared to men and received on-label prescriptions for edoxaban less frequently (73.6% vs. 87.3%, p = 0.01) while being more often overdosed (16.5% vs. 5.5%, p < 0.01). Rates of major and clinically relevant non-major (CRNM) bleeding, stroke or systemic embolism, and one-year all-cause mortality were statistically similar between the two groups. Conclusions Edoxaban appears to be safe in NVAF and T2DM patients, regardless of gender. However, the higher prevalence of inadequate dosing in women, coupled with their worse baseline clinical characteristics, underscores the importance of accurately estimating the appropriate edoxaban dose to maximize its benefits and minimize bleeding risk.