![]() Clinical and biological characteristics of the patients referred to our institution for idarucizumab injection. ![]() To improve patient follow up after reversal and idarucizumab use in our daily practice, we analyzed the impact of initial dabigatran plasma concentrations on the incidence of rebound. We also present 10 new cases referred to our center ( Table 1). Thus, the aim of our study was to analyze clinical and biological data reported in literature to date. 6 Since we think that “no testing” before reversal is questionable, our objective was to identify a patient profile with rebound after reversal. Initial and post reversal dabigatran measurement would indeed be important for any physician deciding upon the proper use of idarucizumab. ![]() In RE-VERSE AD phase III study, the protocol did not include dabigatran measurement before administration of the antidote to guide clinical follow up plasma samples were collected before and after injection and analyzed post hoc. In REVERSE AD, these reappearances were associated with recurrent or continued bleeding in 10 patients with overt, uncontrollable, or life-threatening bleeding among which 3 required an additional dose of idarucizumab. Herein, the authors defined reappearance as an increase of the dabigatran plasma concentration above the 20ng/mL threshold of detection after reversal. However, since idarucizumab commercialization, several case studies 4 3 as well as the complete analysis of RE-VERSE AD, 5 highlighted several cases of patients either having required a second dose of idarucizumab, or with a rebound effect of plasma dabigatran levels (in 114 of 497 patients in complete RE-VERSE AD study). ![]() 2 The 5g dose was calculated to reverse the total body load of dabigatran that was associated with the 99th percentile of the dabigatran levels measured in the phase III study RE-LY. 1 Following the RE-VERSE AD trial, idarucizumab administered as a single 5g IV dose has been licensed for the management of patients with life-threatening bleeding or in case of urgent surgery/procedures while on treatment with dabigatran etexilate. ![]() Major bleeding occurs in about 4% of patients treated with direct oral anticoagulants. ![]()
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