Idarucizumab for Emergency Reversal of Anticoagulant Effects of Dabigatran: Interim Results of a Japanese Post-Marketing Surveillance Study.

Cardiology and Therapy
Masahiro YasakaDaisuke Nakayama

Abstract

Idarucizumab, a monoclonal antibody fragment, was developed to reverse the anticoagulant effect of dabigatran, and it was approved in Japan in September 2016. An all-case post-marketing surveillance is ongoing to collect data in Japanese patients treated with idarucizumab who had serious bleeding (Group A) or required an urgent procedure (Group B). The primary endpoint was the incidence of adverse drug reactions (ADRs). The secondary endpoint was the maximum extent of reversal of the anticoagulant effect of dabigatran based on activated partial thromboplastin time (aPTT) within 4 h after idarucizumab administration. This interim analysis included 262 patients who received idarucizumab. Eighteen patients (6.9%) experienced ADRs within 4 weeks. The reversal effect of idarucizumab based on aPTT within 4 h after idarucizumab administration was assessed in 30 patients and the median maximum percentage reversal was 100%. In Group A, the median time to bleeding cessation in patients without intracranial bleeding was 3.3 h. In Group B, normal intraoperative hemostasis was reported in 63 patients (72.4%). The results of this interim analysis suggest that idarucizumab is safe and effective for the reversal of dabigatran in Japanese patie...Continue Reading

Associated Clinical Trials

References

Sep 1, 2009·The New England Journal of Medicine·Stuart J ConnollyUNKNOWN RE-LY Steering Committee and Investigators
Mar 26, 2011·Circulation Journal : Official Journal of the Japanese Circulation Society·Masatsugu HoriUNKNOWN RE-LY Investigators
Apr 6, 2011·Circulation·Graeme J Hankey, John W Eikelboom
Mar 12, 2013·Blood·Felix SchieleTobias Litzenburger
Jun 8, 2013·Stroke; a Journal of Cerebral Circulation·Masatsugu HoriUNKNOWN RE-LY Investigators
Oct 4, 2016·International Journal of Stroke : Official Journal of the International Stroke Society·H C DienerE Touzé
Nov 16, 2016·Annals of Clinical and Translational Neurology·Johannes Sebastian MutzenbachJohann Sellner
Dec 3, 2016·Thrombosis and Haemostasis·Michael SchmohlJoachim Stangier
Mar 21, 2017·The New England Journal of Medicine·Hugh CalkinsUNKNOWN RE-CIRCUIT Investigators
Jul 12, 2017·The New England Journal of Medicine·Charles V PollackJeffrey I Weitz

❮ Previous
Next ❯

Citations

Jun 19, 2021·Journal of the American College of Cardiology·Antonio Gómez-OutesEmilio Vargas-Castrillón

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT02946931

Software Mentioned

VERSE AD
RE
VERSE

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions
Marwan Sheikh-Taha
The New England Journal of Medicine
Ryan P Radecki, Thomas G DeLoughery
The New England Journal of Medicine
Marc Sorigue
The New England Journal of Medicine
Charles V PollackJeffrey I Weitz
Annals of Emergency Medicine
Michael Gottlieb, Basem Khishfe
© 2021 Meta ULC. All rights reserved