ΠΦΥ -Εκπαίδευση > Συζητήσεις πάνω σε ιατρικά θέματα
Δαβιγατράνη ( Pradaxa ).
Argirios Argiriou:
Το ότι βάλαμε έναν ασθενή σε νεότερο αντιπηκτικό δεν σημαίνει ότι ξενoιάσαμε. Οι ασθενείς αυτοί χρειάζονται σχεδόν το ίδιο στενή παρακολούθηση με αυτούς που παίρνουν Sintrom.
July 6, 2015
Managing Patients Receiving Direct Oral Anticoagulants
David Green, MD, PhD reviewing Gladstone DJ et al. Ann Intern Med 2015 Jun 30.
A new tool assists clinicians in the safe use of these new drugs.
Because the new direct oral anticoagulants (DOACs; apixaban, dabigatran, edoxaban, and rivaroxaban) have the potential to cause serious bleeding, regular patient contact is required to assess changes in health status, answer questions, and check adherence to dosing. To assist clinicians in the safe use of the new DOACs, a group of experts have prepared a checklist for patient monitoring (see resources at Δεν είναι ορατοί οι σύνδεσμοι (links).
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The checklist includes questions about drug adherence, bleeding, renal function, and concomitant medications and has a section that assesses blood pressure and risks for falling. It also includes questions about changes in health status, doses missed during an average week, signs and symptoms of bleeding, and the use of aspirin or nonsteroidal anti-inflammatory agents. A section for recording recent measurements of creatinine clearance, blood pressure, and risk for falls is also included. The checklist is accompanied by tables that provide information about dosing, drug interactions, and periprocedural management.
Comment
Patients taking warfarin usually have laboratory tests every 1 to 3 months; this checklist provides an opportunity for regular contact between patient and prescriber. The authors suggest that patients be assessed at least every 6 months and more often for higher-risk patients, but clinicians might feel more comfortable if the patient checklist is completed at 3-month intervals.
Editor Disclosures at Time of Publication
Disclosures for David Green, MD, PhD at time of publication Grant / Research support NIH
Citation(s):
Gladstone DJ et al. Clinical tool facilitates careful monitoring of patients receiving direct oral anticoagulants. Ann Intern Med 2015 Jun 30; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links).
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Δείτε ειδικότερα:
Direct Oral Anticoagulant (DOAC) Monitoring Checklist and Quick Reference Tables.
Δεν είναι ορατοί οι σύνδεσμοι (links).
Εγγραφή ή Είσοδος
Argirios Argiriou:
Δεν είναι ορατοί οι σύνδεσμοι (links).
Εγγραφή ή ΕίσοδοςΕνδιαφέρον. Πόσο όμως κοστίζει αυτό το αντίδοτο και πότε θα έρθει στην χρεοκοπημένη Ελλάδα;
June 24, 2015
Reversing Dabigatran-Induced Anticoagulation
David Green, MD, PhD reviewing Glund S et al. Lancet 2015 Jun 15. Treschan TA and Beiderlinden M. Lancet 2015 Jun 15. Pollack CV Jr et al. N Engl J Med 2015 Jun 22.
Idarucizumab immediately reversed dabigatran-induced increases in clotting variables without causing serious adverse events.
Dabigatran is a direct thrombin inhibitor that is approved for the prevention of stroke in atrial fibrillation and for the treatment of venous thromboembolism. Bleeding is usually managed by discontinuing the drug or, if severe, by giving a prothrombin complex concentrate. However, a specific antidote would be required if more urgent reversal of the drug were needed.
Now, researchers have developed a monoclonal antibody fragment, idarucizumab, which tightly binds to dabigatran and nullifies its anticoagulant activity. The agent has now been evaluated in two studies: a randomized, placebo-controlled, double-blind, proof-of-concept phase 1 study in healthy male volunteers, and a prospective cohort trial in patients requiring urgent reversal because of bleeding or need for a surgical procedure.
In the first study, conducted by the drug manufacturer, participants were given dabigatran for 4 days and then intravenous doses of idarucizumab, ranging from 1 to 5 g. Coagulation variables (thrombin times, ecarin clotting time, activated clotting time, and partial thromboplastin time) were all prolonged on day 3 of dabigatran dosing, and mild bleeding was observed in four participants (3 with hematuria and 1 with epistaxis). Infusion of idarucizumab resulted in an immediate and complete reversal of the dabigatran-induced increases in clotting tests, which was maintained for at least 72 hours with all but the 1 g dose of idarucizumab. The antidote was well-tolerated; no serious or severe adverse events were observed.
The second study included 90 patients who were being treated with dabigatran, 51 with bleeding (intracranial, 18; gastrointestinal, 20), and 39 requiring urgent interventions. The median time since the last dose of dabigatran was 15.4 hours, and the dose of idarucizumab used for reversal was 5 g. After infusion of the antidote, the dilute thrombin time was normalized in more than 90% of patients, and the concentration of unbound dabigatran was <20 ng/mL at 24 hours in 79%. In the patients with hemorrhage, the median time for bleeding cessation was 11.4 hours, and in those undergoing surgery, normal intraoperative hemostasis was reported in 92%. In the 72 hours following administration of idarucizumab, only one patient had a thrombotic event.
COMMENT
The safety and specificity of idarucizumab in reversing the anticoagulant effects of dabigatran are well documented in these studies of healthy volunteers, bleeding patients, and those undergoing surgery. The introduction of this and other antidotes to the new oral anticoagulants is an important step in the development of these agents, and it raises the question of whether every patient starting on one of these drugs should receive a vial containing the specific antidote in case bleeding occurs and the reversal agent might not be immediately available.
EDITOR DISCLOSURES AT TIME OF PUBLICATION
Disclosures for David Green, MD, PhD at time of publication
Grant / Research supportNIH
CITATION(S):
Glund S et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: A randomised, placebo-controlled, double-blind phase 1 trial. Lancet 2015 Jun 15; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links).
Εγγραφή ή Είσοδος)
Treschan TA and Beiderlinden M.Antidotes for anticoagulants: A long way to go. Lancet 2015 Jun 15; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links).
Εγγραφή ή Είσοδος)
Pollack CV Jr et al. Idarucizumab for dabigatran reversal. N Engl J Med 2015 Jun 22; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links).
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--- Τέλος παράθεσης ---
October 22, 2015
Antidote to Dabigatran Is Approved
David Green, MD, PhD David Green, MD, PhD
Idarucizumab quickly nullifies the anticoagulant effect of dabigatran. Dabigatran (Pradaxa) is an oral anticoagulant approved for treating patients who have atrial fibrillation or venous thromboembolism. The most important adverse effect of the drug is bleeding, but a specific antidote to reverse this anticoagulant has not been available previously.On October 16, 2015, the U.S. FDA approved idarucizumab (Praxbind), a monoclonal antibody fragment that binds tightly to dabigatran and nullifies its anticoagulant activity. Approval was based on data from a randomized, placebo-controlled trial in healthy volunteers and a study of patients requiring urgent reversal because of bleeding or need for a surgical procedure (JW Oncol Hematol Aug 2015 and Lancet 2015; 386:680). In addition, in an ongoing, open-label trial of patients with life-threatening or uncontrolled bleeding or who require emergency surgery or urgent procedures, 89% of 123 enrollees exhibited complete reversal of dabigatran within 4 hours of receiving idarucizumab.Comment Four new oral anticoagulant drugs currently are available in the U.S: Three inhibit coagulation factor Xa, and one — dabigatran — is a thrombin inhibitor. Major bleeding with these drugs generally has been less common than with vitamin K antagonists such as warfarin, but prescribers must be able to rapidly reverse their anticoagulant activity when dangerous bleeding or drug overdosing occurs, or when patients require urgent surgery. Clinicians now can infuse idarucizumab to bind dabigatran, and an antidote (andexanet alfa) for the factor Xa–inhibiting drugs currently is in clinical trials.
Editor Disclosures at Time of PublicationDisclosures for David Green, MD, PhD at time of publication Grant / Research support NIH
Citation(s): FDA Office of Hematology and Oncology Products.Idarucizumab. 2015 Oct 15. (Δεν είναι ορατοί οι σύνδεσμοι (links).
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Argirios Argiriou:
Δεν είναι ορατοί οι σύνδεσμοι (links).
Εγγραφή ή ΕίσοδοςΕνδιαφέρον. Πόσο όμως κοστίζει αυτό το αντίδοτο και πότε θα έρθει στην χρεοκοπημένη Ελλάδα;
June 24, 2015
Reversing Dabigatran-Induced Anticoagulation
David Green, MD, PhD reviewing Glund S et al. Lancet 2015 Jun 15. Treschan TA and Beiderlinden M. Lancet 2015 Jun 15. Pollack CV Jr et al. N Engl J Med 2015 Jun 22.
Idarucizumab immediately reversed dabigatran-induced increases in clotting variables without causing serious adverse events.
Dabigatran is a direct thrombin inhibitor that is approved for the prevention of stroke in atrial fibrillation and for the treatment of venous thromboembolism. Bleeding is usually managed by discontinuing the drug or, if severe, by giving a prothrombin complex concentrate. However, a specific antidote would be required if more urgent reversal of the drug were needed.
Now, researchers have developed a monoclonal antibody fragment, idarucizumab, which tightly binds to dabigatran and nullifies its anticoagulant activity. The agent has now been evaluated in two studies: a randomized, placebo-controlled, double-blind, proof-of-concept phase 1 study in healthy male volunteers, and a prospective cohort trial in patients requiring urgent reversal because of bleeding or need for a surgical procedure.
In the first study, conducted by the drug manufacturer, participants were given dabigatran for 4 days and then intravenous doses of idarucizumab, ranging from 1 to 5 g. Coagulation variables (thrombin times, ecarin clotting time, activated clotting time, and partial thromboplastin time) were all prolonged on day 3 of dabigatran dosing, and mild bleeding was observed in four participants (3 with hematuria and 1 with epistaxis). Infusion of idarucizumab resulted in an immediate and complete reversal of the dabigatran-induced increases in clotting tests, which was maintained for at least 72 hours with all but the 1 g dose of idarucizumab. The antidote was well-tolerated; no serious or severe adverse events were observed.
The second study included 90 patients who were being treated with dabigatran, 51 with bleeding (intracranial, 18; gastrointestinal, 20), and 39 requiring urgent interventions. The median time since the last dose of dabigatran was 15.4 hours, and the dose of idarucizumab used for reversal was 5 g. After infusion of the antidote, the dilute thrombin time was normalized in more than 90% of patients, and the concentration of unbound dabigatran was <20 ng/mL at 24 hours in 79%. In the patients with hemorrhage, the median time for bleeding cessation was 11.4 hours, and in those undergoing surgery, normal intraoperative hemostasis was reported in 92%. In the 72 hours following administration of idarucizumab, only one patient had a thrombotic event.
COMMENT
The safety and specificity of idarucizumab in reversing the anticoagulant effects of dabigatran are well documented in these studies of healthy volunteers, bleeding patients, and those undergoing surgery. The introduction of this and other antidotes to the new oral anticoagulants is an important step in the development of these agents, and it raises the question of whether every patient starting on one of these drugs should receive a vial containing the specific antidote in case bleeding occurs and the reversal agent might not be immediately available.
EDITOR DISCLOSURES AT TIME OF PUBLICATION
Disclosures for David Green, MD, PhD at time of publication
Grant / Research supportNIH
CITATION(S):
Glund S et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in healthy male volunteers: A randomised, placebo-controlled, double-blind phase 1 trial. Lancet 2015 Jun 15; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links).
Εγγραφή ή Είσοδος)
Treschan TA and Beiderlinden M.Antidotes for anticoagulants: A long way to go. Lancet 2015 Jun 15; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links).
Εγγραφή ή Είσοδος)
Pollack CV Jr et al. Idarucizumab for dabigatran reversal. N Engl J Med 2015 Jun 22; [e-pub]. (Δεν είναι ορατοί οι σύνδεσμοι (links).
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--- Τέλος παράθεσης ---
Κατέφθασε στην Σουηδία με το εμπορικό όνομα Praxbind.
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Argirios Argiriou:
An Antidote for Dabigatran
David Green, MD, PhD Reviewing Pollack CV Jr et al., N Engl J Med 2017 Jul 11;
Idarucizumab rapidly reverses the effects of dabigatran in bleeding patients and in those undergoing urgent procedures.
Δεν είναι ορατοί οι σύνδεσμοι (links).
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Argirios Argiriou:
October 2017
Hong KS, et al. JAMA Neurol. 2017;74(10):1206-15. doi: 10.1001/jamaneurol.2017.2161
Rivaroxaban vs Warfarin Sodium in the Ultra-Early Period After Atrial Fibrillation–Related Mild Ischemic Stroke.
A Randomized Clinical Trial
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Meaning: Rivaroxaban and warfarin had comparable safety and efficacy for early anticoagulation in mild atrial fibrillation–related acute ischemic stroke.
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