This week, the RE-ALIGN
study was published in the New England Journal of Medicine, examining the use
of dabigatran in patients undergoing a mechanical valve replacement or who
underwent one at least three months earlier.
This study was a dose-finding study for dabigatran primarily looking at
plasma trough concentrations in patients receiving 150-300 mg po bid depending
on renal function (Yes, higher than doses used for atrial fibrillation). The pharmacokinetic model used in the RE-LY
study (the >18,000 patient study resulting in approval of dabigatran) was
used to target certain trough concentrations and dabigatran titration was
performed at prespecified intervals.