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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| ISTH bleeding | ISTH bleeding | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| non-major bleeding events | non-major bleeding events | through study completion, an average of 1 year |
| Cardiovascular events | death, stroke, embolism, any bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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AF patients who are taking low dose edoxaban
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Keun On, MD | Contact | 82-2-3410-3420 | yk.on@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Young Keun On, MD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38859644 | Derived | Kim JY, Kim J, Park SJ, Park KM, Han SJ, Kim DK, Park YM, Lee SH, Park JS, On YK; LEDIOS Registry Investigators. Optimal Dose of Edoxaban for Very Elderly Atrial Fibrillation Patients at High Risk of Bleeding: The LEDIOS Registry. Korean Circ J. 2024 Jul;54(7):398-406. doi: 10.4070/kcj.2024.0084. Epub 2024 May 10. | |
| 36513051 | Derived |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| through study completion, an average of 1 year |
| any side effect | any side effect | through study completion, an average of 1 year |
| Kim JY, Choi EK, Lim HE, Oh YS, Cho Y, On YK. Outcomes of On-Label Reduced-Dose Edoxaban in Patients With Atrial Fibrillation: The LEDIOS Registry. J Korean Med Sci. 2022 Dec 12;37(48):e335. doi: 10.3346/jkms.2022.37.e335. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |