ETNA DUS
Research type
Research Study
Full title
Edoxaban prescription patterns in Europe: a retrospective drug utilisation chart review study
IRAS ID
219550
Contact name
Ameet Bakhai
Contact email
Sponsor organisation
DAIICHI SANKYO EUROPE GMBH
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
The aim of this study is to provide insights about the prescription patterns of edoxaban. Edoxaban is an oral drug which makes blood thinner (anti-coagulation) by blocking the effect of coagulation factor Xa- an enzyme that helps blood thicken (coagulation) , and is approved for use in patients with atrial fibrillation and venous thromboembolism (indications). The potential off-label use of edoxaban (use in indications or patient population other than those for which the drug is approved to be used) in unapproved indications was considered low, because of the availability of approved, indicated and well-established treatment alternatives. However, as it is the case with all other new anticoagulants, a residual risk for off-label use might be considered in conditions (for which Edoxaban is not approved) that usually also require mid- or long-term anticoagulant treatment or in cases of poor compliance or contraindications for the patient. One of the ways in which DSE (Daiichi Sankyo Europe) addresses the concern for an off-label use of Edoxaban, is this drug utilization study, which is designed to produce insight on how edoxaban is used in real practice.
The objectives of the study are to characterize the institutions (hospitals and private practices) and physicians who prescribe edoxaban, as well as the patients to whom it is prescribed. The study also aims to evaluate the patterns of use for edoxaban, and the effectiveness of the prescriber educational programs as a risk-minimization tool. Eligible patients include all patients with at least one edoxaban prescription in their medical record regardless of indication. Both hospitals and private practices where edoxaban is prescribed will be considered for participation. The study involves a retrospective chart review and therefore participating patients will not undergo any study related procedures. Rather, data that is already available as part of standard care will be collected.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
17/EE/0007
Date of REC Opinion
30 Jan 2017
REC opinion
Further Information Favourable Opinion