Idarucizumab Deemed Effective for Dabigatran Reversal
Findings among patients with serious bleeding or who require an urgent procedure
MONDAY, June 22, 2015 (HealthDay News) -- An antibody fragment, idarucizumab, can reverse the anticoagulant effects of dabigatran, according to a study published online June 22 in the New England Journal of Medicine. The research was published to coincide with the International Society on Thrombosis and Haemostasis 2015 Congress, held from June 20 to 25 in Toronto.
Charles V. Pollack Jr., M.D., from Pennsylvania Hospital in Philadelphia, and colleagues examined the safety and efficacy of 5 g of intravenous idarucizumab. The interim analysis included 90 patients who received idarucizumab (51 patients who had serious bleeding [group A] and 39 who required an urgent procedure [group B]).
The researchers found that the median maximum percentage reversal of the anticoagulation effect of dabigatran within four hours after idarucizumab administration was 100 percent among 68 patients with an elevated dilute thrombin time and 81 patients with an elevated ecarin clotting time at baseline. In 88 to 98 percent of the patients, idarucizumab normalized the test results, which was evident within minutes. In 79 percent of patients, concentrations of unbound dabigatran remained below 20 ng/mL at 24 hours. Hemostasis was restored at a median of 11.4 hours in 35 patients of group A, who could be assessed. Normal intraoperative hemostasis was reported in 33 of 36 patients in group B who underwent a procedure, with mildly and moderately abnormal hemostasis reported in two patients and one patient, respectively.
"Idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes," the authors write.
The study was funded by Boehringer Ingelheim, the manufacturer of idarucizumab.