Baseline Clinical Characteristics of Patients from the Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in TüRkiye Study

Abstract

Objective: A post-authorization safety study with a prospective design focusing on the safety of edoxaban treatment in Türkiye has not yet been conducted. The Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in TüRkiye (ETAF-TR) study was designed to evaluate the safety and effectiveness of edoxaban treatment in atrial fibrillation (AF). The baseline results of the ETAF-TR study describe the demographic, clinical, and laboratory characteristics of the study population. Method: The ETAF-TR study (NCT04594915) is a prospective, national, multicenter, observational, post-authorization safety study conducted in 50 outpatient cardiology clinics. Results: Overall, 1,053 patients with AFtreated with edoxaban forstroke prevention were enrolled in the study between August 2020 and May 2022. The mean age of the study population was 70.1 +/- 11.3 years, and 59.0% of the patients were female. Mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >= 75 years, Diabetes, Stroke/TIA/thromboembolism, Vascular disease, Age 65-74 years, Sex category) and HAS-BLED scores (Hypertension, Abnormal renal/ liver function, Stroke, Bleeding history/predisposition, Labile INR, Elderly, Drugs/alcohol) were 3.5 and 1.6, respectively. Of the 1,053 patients, 843 (80.1%) received standard-dose edoxaban and 210 (19.9%) received reduced-dose edoxaban. Of the 1,053 patients, 38 (3.6%) had off-label use of edoxaban therapy. Among the remaining 1,015 patients, 834 (82.2%) received an appropriate dose of edoxaban and 181 (17.8%) received an inappropriate dose of edoxaban according to the Summary of Product Characteristics (SmPC) criteria. Conclusion: Edoxaban has been used in a wide spectrum of patients with AF in daily routine practice, with good overall adherence to the SmPC. As the largest national pharmacovigilance study to date, the ETAF-TR study will provide detailed insight into the safety of edoxaban treatment.