Authors’ Reply to Kamel et al.: “Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study”
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منابع مشابه
Authors’ Reply to Kamel et al.: “Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study”
We thank Dr. Kamel and colleagues for their valuable comments [1] and would like to provide the following response to the questions raised. The unbound dabigatran concentration reflects the level of active dabigatran in the blood. Administration of idarucizumab 5 g to volunteers of various age groups and with different degrees of renal impairment reduced unbound dabigatran concentrations to bel...
متن کاملEffect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study
BACKGROUND AND OBJECTIVES Idarucizumab is an antibody fragment that specifically reverses dabigatran-mediated anticoagulation. Safety, pharmacokinetics and pharmacodynamics of idarucizumab were investigated in dabigatran-treated, middle-aged, elderly and renally impaired volunteers with characteristics similar to patients receiving anticoagulant therapy. METHODS In this randomized, double-bli...
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BACKGROUND Specific reversal agents for non-vitamin K antagonist oral anticoagulants are lacking. Idarucizumab, an antibody fragment, was developed to reverse the anticoagulant effects of dabigatran. METHODS We undertook this prospective cohort study to determine the safety of 5 g of intravenous idarucizumab and its capacity to reverse the anticoagulant effects of dabigatran in patients who h...
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BACKGROUND Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran. METHODS We performed a multicenter, prospective, open-label study to determine whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A) or were about to undergo an urgent pro...
متن کاملSpotlight on idarucizumab and its potential for the reversal of anticoagulant effects of dabigatran
Idarucizumab is the first targeted antidote of dabigatran, a direct oral anticoagulant used for prevention and treatment of venous thromboembolism and prevention of stroke in atrial fibrillation. Idarucizumab is a humanized fragment of a monoclonal antibody, which binds dabigatran reversibly with high affinity and, when administered intravenously, immediately neutralizes its anticoagulant effec...
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ژورنال
عنوان ژورنال: Clinical Pharmacokinetics
سال: 2016
ISSN: 0312-5963,1179-1926
DOI: 10.1007/s40262-016-0493-1