Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors
Presentation
Name: Priscilla Erazo A
Medical English "A"
priscila.erazo@cu.ucsg.edu.ec
Definition
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Andexanet alfa is a modified recombinant inactive from of human factor Xa developed for reversal of factor Xaa Inhibitors.
Andexanet alfa is a specific reversal agent approved by the US Food and Drug Administration and the European Medicines Agency for uncontrolled or life-threatening bleeding related to the oral FXa inhibitors apixaban and rivaroxaban
How do NOACs work?
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Aplication in Medicine
Andexanet alfa is a modified, recombinant, enzymatically inactive form of FXa, wich binds and sequesters FXa inhibitors, there by neutralizing theiranti-FXa activity
Aplication in Medicine
Studies in healthy volunteers have shown that administration of andexanet resulted in a median >92% reduction from baseline in anti-FXa activity of apixaban and rivaroxaban, with a rapid onset of effect within minutes after the start of administration.
This was associated with a similarly rapid increase in thrombin generation that persisted up to 22 hours after the completion of Andexanet
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Pros & Cons
Pros
Indications for the use of these agents include the prevention of stroke in patients with nonvalvular atrial fibrillation, the treatment and secondary prevention of deep-vein thrombosis and pulmonary embolism, and the prevention of venous thrombosis after orthopedic surgery.
Cons
Pros
&
Cons
The lack of specific antidote to reverse their anticoagulant effects is an important limitation, patients may also be at increased risk for bleeding if emergeney surgery is resquired
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Issue applied in Ecuador
This Andexanet Alfa since the day it was officialy realised from the FDA, thas help a lot of people with their bleading problems.
Issue applied in Ecuador
Until now, Ecuador does not have a database that indicates the prevalence of this disease at the local level, neither eith studies that give us a real perspective of wich treatment is the most suitablein our population, but due to the increasein the incidence of this pathology we must have a registry that allows us to choose for the best therapeutic options available
Conclusion
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In patients with acute major bleeding associated with the use of a factor Xa inhibitor, treatment with Andexanet markedly reduced anti-factor Xa activity, and 82% of patients had excellent or good hemostatic efficacy at 12 hours, as adjudicated according to prespecified criteria.