Patients in the subgroup with severe renal dysfunction had the worst clinical profile overall, and as predicted, had a markedly elevated average plasma level of dabigatran, 231 ng/mL, nearly five times higher than the 47-ng/mL average level in patients with normal renal function. Idarucizumab reversed dabigatran completely and rapidly in study

The subgroups included 91 patients with severe dysfunction with a creatinine clearance rate of less than 30 mL/min 127 with moderate dysfunction and a clearance rate of 30-49 mL/min 163 with mild dysfunction and a clearance rate of 50-79 mL/min and 108 with normal function and a creatinine clearance of at least 80 mL/min. The new, post hoc analysis divided patients into four subgroups based on their kidney function, and focused on the 489 patients for whom renal data were available out of the 503 patients in the study ( N Engl J Med.

To examine whether idarucizumab’s activity varied by renal function he used data from the patients enrolled in the RE-VERSE AD (Reversal Effects of Idarucizumab on Active Dabigatran) study, the pivotal dataset that led to idarucizumab’s U.S. Eikelboom, a hematologist at McMaster University in Hamilton, Ont. That’s been a fear of clinicians,” explained Dr.

“Plasma dabigatran levels might be sky high, so a standard dose of idarucizumab might not work. The ability of idarucizumab (Praxbind), conditionally approved by the Food and Drug Administration in 2015 and then fully approved in April 2018, to work in patients with impaired renal function has been an open question and concern because dabigatran (Pradaxa) is excreted renally, so it builds to unusually high levels in patients with poor kidney function.

Pradaxa reversal