Publications by authors named "J Stangier"
Background: Idarucizumab is a monoclonal antibody fragment that reverses dabigatran anticoagulation. Pharmacokinetics (PK) of idarucizumab have been described in healthy, elderly, or renally impaired (RI) volunteers, but PK data in patients are lacking.
Objectives: This analysis describes the PK of idarucizumab and its target dabigatran in bleeding/surgical patients.
Background: Physiological age-related changes in the haemostatic and coagulation systems result in differing anticoagulant assay responses to standard anticoagulants. Therefore, we investigated the response of anticoagulant assays to dabigatran etexilate (DE) in children compared with adults.
Objective: This article assesses the relationship between plasma dabigatran concentration and coagulation assay results across age groups in children and adults.
Article Synopsis
- Idarucizumab is a monoclonal antibody fragment that binds to the anticoagulant dabigatran, and this study aimed to evaluate its safety and effects on dabigatran-induced anticoagulation in healthy Japanese males.
- The study involved two phases, where subjects received varying doses of idarucizumab alone or alongside dabigatran, with measurements taken for anticoagulation parameters.
- The results showed that idarucizumab effectively reversed dabigatran's anticoagulation effects without causing adverse events or procoagulant effects, making it a safe option for reversing anticoagulation.
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 procedure (group B). The primary end point was the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time.
Aims: Idarucizumab, a humanized monoclonal anti-dabigatran antibody fragment, is effective in emergency reversal of dabigatran anticoagulation. Pre-existing and treatment-emergent anti-idarucizumab antibodies (antidrug antibodies; ADA) may affect the safety and efficacy of idarucizumab. This analysis characterized the pre-existing and treatment-emergent ADA and assessed their impact on the pharmacokinetics and pharmacodynamics (PK/PD) of idarucizumab.
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