Why the study?
Does edoxaban 60 mg once daily improve safety and tolerability compared to placebo in healthy subjects switching from warfarin?
Population
72 healthy subjects switching from warfarin (target INR 2.0 to 3.0)
Comparison
Edoxaban 60 mg oral once daily for 5 days… vs Matching placebo for 5 days, started 24 h after…
Design
RCT, randomized, matching placebo
Follow-up
5 days
Key result
Edoxaban 60 mg administered 24 hours after the last dose of warfarin was safe and well tolerated in healthy subjects, with transient increases in INR (P<0.0001 vs placebo).
Authors
Loading...
Supports 24-hour edoxaban initiation after warfarin; extends healthy-volunteer data to guide patient switching trials.
RCT (n=72)
Placebo-controlled
Randomized
Does edoxaban 60 mg once daily improve safety and tolerability compared to placebo in healthy subjects switching from warfarin?
Switching from warfarin to edoxaban 24 hours after the last warfarin dose is safe and well-tolerated in healthy subjects, with expected transient increases in coagulation assays.
Mendell et al. (2012) conducted an RCT in Healthy subjects switching from warfarin (n=72). Edoxaban vs. Placebo was evaluated on Safety/tolerability. Edoxaban 60 mg administered 24 hours after the last dose of warfarin was safe and well tolerated in healthy subjects, with transient increases in INR (P<0.0001 vs placebo).