dose reductions were implemented in both the low-dose (30mg/day) and high-dose edoxaban (60mg/day) arms in the Phase 3 ENGAGE AF TIMI-48 trial in order to prevent unnecessary bleeding. The edoxaban dose was reduced by 50% for patients withmoderate renal impairment, patients with low body...
Inclusion criteria: AF patients on a stable 30 mg daily dose of edoxaban for at least 7 days. Exclusion criteria: (1) at least one missed dose in the last seven days; (2) creatinine clearance <30 mL/min (Cockcroft-Gault formula); (3) serious comorbidities that could affect prognosis; ...
(A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL 95 ML/MIN: SAVAYSA should not be used in patients with CrCL 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonval- vular atrial fibrillation patients with CrCL 95 mL/min had an increased rate of ischemic stroke with...
Randomization is performed with the use of a central, 24-hour, interactive Web response system and stratified according to geographic region (Asia, Eastern Europe, Western Europe), clinical presentation (ACS or stable coronary disease), and presence of edoxaban dose reduction criteria. The edoxaban-...
Exclusion criteria included a history of major bleeding, trauma, or surgical procedure within 6 months of the first dose; malignancy in the past 5 years; and coagulation disorders or other conditions and medications that could affect the absorption and/or excretion of the study drug. The main ...
Thus, even in patients with NVAF and AHF, edoxaban anticoagulation therapy with guided dose adjustment is considered to be a safe and appropriate intervention. In particular, patients with reduced creatinine clearance should adhere to dose adjustment criteria.jRCTs031190006 (Japan Registry of Clinical ...