Daiichi-Sankyo is currently undertaking a non-interventional multicountry post-approval safety study (ETNA-AF study - EU-PAS register numbers EUPAS8896), in order to gain insight into the safety of edoxaban in non-preselected patients with non-valvular atrial fibrillation (NVAF) treated with edoxaban.
In this non-interventional retrospective study, we aim to evaluate the safety and efficacy of edoxaban in patients diagnosed with NVAF between 2015 and 2021 in the United Kingdom, using electronic medical record from the Clinical Practice Research Datalink (CPRD) Aurum with linkage to Hospital Episode Statistics (HES) databases. This study will be used to put in perspective the results of the ETNA-AF study pertaining to UK centers.
We will use Hospital Episode Statistics (HES) data to identify clinical events of interest, hospitalizations for all causes or related to specific conditions. Linkage to Office of National Statistic (ONS) will allow the determination of mortality rates (all-causes or Cardiovascular-specific).
The primary analysis will estimate the frequency of occurrence of safety events including major bleeding events, non-major bleeding events, drug-related adverse events and mortality in patients with NVAF treated with edoxaban during an overall observational period of up to 4 years.
The secondary analysis will assess the frequency of occurrence during the follow-up period of the following endpoint: stroke (ischaemic, haemorrhagic and unknown type), systemic embolic events (SEE), Transient ischemic attack (TIA), Myocardial infarction (MI), hospitalizations related to cardiovascular condition (including AF-related hospitalization) and MACE (major adverse cardiovascular events, composite endpoint of non-fatal MI, non-fatal stroke, non-fatal SEE and death due to CV cause or bleeding)
For each endpoint, a Kaplan-Meier plot will be displayed and the proportion of patients with at least one event of interest will be also provided.
Any bleeding; Major bleeding including gastrointestinal bleeding and Intracranial hemorrhage; Non-major bleeding; Adverse drug reactions (listed in the Summary of Product Characteristics); All-cause mortality; Cardiovascular-related mortality; Stroke (All type; Ischemic stroke; Hemorrhagic stroke; unknown type); Systemic embolic events (SEE); Transient ischemic attack (TIA); Myocardial infarction (MI); Hospitalizations related to cardiovascular (CV) condition (including AF related hospitalization); Major adverse cardiovascular events (MACE, composite endpoint of non-fatal MI, non-fatal stroke, non-fatal SEE and death due to CV cause or bleeding)
FLORENT Guelfucci - Chief Investigator - Syneos Health Commercial France SARL
FLORENT Guelfucci - Corresponding Applicant - Syneos Health Commercial France SARL
Armel Ngami - Collaborator - Syneos Health Commercial France SARL
Eva-Maria Fronk - Collaborator - Daiichi-Sankyo Europe
Katharina Wenz-Poeschl - Collaborator - Daiichi-Sankyo Europe
Petra Laeis - Collaborator - Daiichi-Sankyo Europe
Ruediger Smolnik - Collaborator - Daiichi-Sankyo Europe