2015年11月10日星期二

Boehringer Ingelheim announced results of a new analysis of idarucizumab

Boehringer Ingelheim announced two assessments recently approved and listed by the trade name Praxbind® rapid approval process in the United States idarucizumab (Thai Bi Full ® (dabigatran etexilate) is a specific reversal agent) of the new analysis results The results are published in the 2015 American Heart Association (AHA) Scientific Sessions in Orlando held. [1, 2] A study of the administration is started again after idarucizumab antithrombotic therapy analysis. [1] Non-valvular atrial fibrillation anticoagulation treatment is very important to start again, to help rule out the potential risk of stroke.
One pair of the ongoing Phase III interim analysis data RE-VERSE AD ™ trials showed that the administration may at any time after the restart idarucizumab alternative antithrombotic treatment. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab treatment after the introduction of an alternative antithrombotic therapy (such as heparin) time range is from 0.2 to 77.2 days, whereas for patients requiring emergency surgery or interventional procedures is 0 days to 40.8 days. For the presence of the patient is unable to control or life-threatening bleeding of, idarucizumab restart time after treatment dabigatran treatment is 1.3 to 90.6 days, and require emergency surgery or interventional procedures in patients time is 1 to 63.31 days. [1]
"Consideration should be given appropriate time to restart as soon as possible antithrombotic therapy to reduce the potential risk of stroke in patients with non-valvular atrial fibrillation," Thomas Jefferson University in Philadelphia, vice provost, professor of emergency medicine and RE-VERSE AD ™ principal investigator Dr. Charles Pollack He said: "The results of this interim analysis of a phase III study RE-VERSE AD ™ broadens the doctors start anticoagulant therapy again at the need to give idarucizumab rare emergency situations, the role reversal of dabigatran after cognition."
idarucizumab second report included a study of coagulation factor complex [for example, recombinant coagulation factor Ⅶa, 3- or 4-factor prothrombin complex concentrate (PCC) and activated PCC] in vitro efficacy studies idarucizumab presence. The results show, idarucizumab reversal of the anticoagulant effect of dabigatran against clotting factor complex. [2] This result is very important because often the management of acute bleeding in patients using these drugs. The study also showed that the use has been listed idarucizumab not inhibit other anticoagulants (direct factor Xa inhibitor, heparin or other direct thrombin inhibitor) anticoagulant effect.
"These are analyzed from the interim AD ™ test period III RE-VERSE resulting data show idarucizumab antithrombotic therapy may allow doctors to manage more flexible, and better control over treatment decisions to accept dabigatran-treated patients did . "Professor Jorg Kreuzer cardiovascular therapeutic area vice president of medical Boehringer Ingelheim said," Today published data support the following observations, although in the case of the clinical need to use idarucizumab very little, but doctors and patients, specificity Reversal agents may provide an important treatment option. "

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