Atrial Fibrillation
Conditions
Keywords
safety, effectiveness, low dose
Brief summary
The efficacy and safety of edoxaban has not been adequately studied in Asians versus non-Asians, who are quite different physiologically from each other. Compared with non-East Asian patients, the East Asia patients were twice as likely to have the reasons for requiring dose reduction of edoxaban, such as CrCl 30-50 ml/min (30.0% and 18.2%, respectively), weight ≤60 kg (30.6% and 7.8%, respectively), or concomitant use of verapamil or quinidine (P-gp inhibitors, 6.6% and 3.3%, respectively). This study is aimed to evaluate the safety of the low dose edoxaban therapy in patients with high bleeding risk and non-valvular AF in the real world population of Korea.
Detailed description
The efficacy and safety of edoxaban has not been adequately studied in Asians versus non-Asians, who are quite different physiologically from each other. Although 1,943 patients from East Asia (1,010 were from Japan, 469 from China, 234 from Taiwan, and 230 from South Korea) were included in ENGAGE AF-TIMI 48, majority of the patient (19,162) were from non-East Asia. Compared with non-East Asian patients, the East Asia patients were twice as likely to have the reasons for requiring dose reduction of edoxaban, such as CrCl 30-50 ml/min (30.0% and 18.2%, respectively), weight ≤60 kg (30.6% and 7.8%, respectively), or concomitant use of verapamil or quinidine (P-gp inhibitors, 6.6% and 3.3%, respectively). Due to the relatively small number of patients in the East Asian group included in the analysis compared with that of the patients in the non-East Asian group, a limitation preventing it from providing sufficient power for such comparison is unavoidable. This study is aimed to evaluate the safety of the low dose edoxaban therapy in patients with high bleeding risk and non-valvular AF in the real world population of Korea.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* atrial fibrillation low dose edoxaban
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ISTH bleeding | through study completion, an average of 1 year | ISTH bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| non-major bleeding events | through study completion, an average of 1 year | non-major bleeding events |
| Cardiovascular events | through study completion, an average of 1 year | death, stroke, embolism, any bleeding |
| any side effect | through study completion, an average of 1 year | any side effect |
Countries
South Korea