Real-world data on the safety and effectiveness of edoxaban for stroke prevention in elder individuals with atrial fibrillation in line with results from ENGAGE AF-TIMI 48 trial
The results of a large real-world, observational cohort study, investigating the safety and effectiveness of two different doses of edoxaban in individuals with atrial fibrillation, appear in line with data from the ENGAGE AF-TIMI 48 clinical trial. The findings reinforce the safety and effectiveness profile of edoxaban for elder individuals with atrial fibrillation in routine clinical practice.
In the study, researchers employed data from Danish nationwide registries on 643 individuals who received 30mg of edoxaban and 1642 participants who were administered 60mg of edoxaban — similar proportions of patients received these drug doses in the ENGAGE AF-TIMI 48 trial.
The primary effectiveness study endpoint was defined by the occurrence of thromboembolism — stroke and systemic embolism. Thromboembolism rates amongst individuals receiving 30 or 60mg of edoxaban were observed to be 2.07 and 1.67 per 100 person-years respectively.
Edoxaban safety, determined by a composite of intracranial, gastrointestinal and major bleeding incidences, was similar between individuals who received low- or regular-dose edoxaban.
Lead study author Peter Brønnum Nielsen, (Aalborg University; Denmark) stated: “These new data, reporting on outcomes in a European [atrial fibrillation] population seen in routine clinical practice, are reassuring as they reinforce previous evidence that edoxaban has a good safety profile and is an effective treatment for the prevention of stroke in a broad [atrial fibrillation] population.”
Wolfgang Zierhut, Executive Director of Medical Affairs at Daiichi Sankyo (Munich, Germany), commented: “Real-world data, such as these, provide us with a greater understanding of [atrial fibrilation] treatment pathways and broaden our insight into the patient population. We are committed to adding to the growing body of evidence on the use of edoxaban through real-world data, particularly in the underserved elderly population.”
The study authors conclude that additional real-world studies are now required to assess the comparative effectiveness of edoxaban versus other antithrombotic treatment options.
Sources:
Nielsen PB, Larsen TB, Skjøth F, Søgaard M, Lip GYH. Effectiveness and safety of edoxaban in patients with atrial fibrillation: data from the Danish Nationwide Cohort. EHJ-CVP. doi:10.1093/ehjcvp/pvz070 (2019) (Epub ahead of print);