EFFICACY AND SAFETY IN PATIENTS WITH RENAL IMPAIRMENT IN THE ENGAGE AF-TIMI 48 TRIAL
Once-daily LIXIANA® (edoxaban) demonstrated similar risk reduction in efficacy vs well-managed warfarin in NVAF patients by renal function (CrCl 30–50, and > 50 mL/min).1
STROKE OR SYSTEMIC EMBOLISMa
a Stratified by CrCl 30–50 mL/min (moderate dysfunction) and > 50 mL/min (mild or no dysfunction).1
b Includes patients taking LIXIANA® 60 mg and those dose-reduced to 30 mg.
c Median time-in-therapeutic range (TTR): 66.9 % in CrCl 30–50 mL/min, and 68.7 % in CrCl > 50 mL/min, respectively.1
d CrCl 30–50 mL/min is one of three items for dose reduction criteria.
e Hazard ratio.
f Confidence interval.
g Includes patients assigned to the LIXIANA® 60 mg group, who met the dose reduction criteria and took LIXIANA® 30 mg instead of 60 mg.
Once-daily LIXIANA® (edoxaban) demonstrated consistently favorable safety vs well-managed warfarin in NVAF patients by renal function (CrCl 30–50, and > 50 mL/min).1
MAJOR BLEEDINGa
a Stratified by CrCl 30–50 mL/min (moderate dysfunction) and > 50 mL/min (mild or no dysfunction).1
b Includes patients taking LIXIANA® 60 mg and those dose-reduced to 30 mg.
c Median time-in-therapeutic range (TTR): 66.9% in CrCl 30–50 mL/min, and 68.7% in CrCl > 50 mL/min, respectively.1
d CrCl 30–50 mL/min is one of three items for dose reduction criteria.
e Includes patients assigned to the LIXIANA® 60 mg group, who met the dose reduction criteria and took LIXIANA® 30 mg instead of 60 mg.
The primary efficacy end point was the composite of all stroke (ischemic or hemorrhagic) or systemic embolism (S/SE). The primary safety end point was the time to the first occurrence of major bleeding as defined by the International Society on Thrombosis and Haemostasis as (i) fatal bleeding; and/or (ii) symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome, and/or (iii) bleeding causing a fall in haemoglobin level of 2.0 g/dL or more, or leading to transfusion of two or more units of whole blood or red cells.2
