Jan 10 2015

george

Xarelto Bleeding Risks

Since November of 2014, several lawyer-inspired Facebook threads have implicated rivaroxaban (Xarelto) in instance of “uncontrollable bleeding events and blood clots.” The October 9, 2014 issue of the ASH‘s Blood journal presents a meta-analysis that reviewed twelve randomized controlled trials involving 102,607 patients taking TSOACs (target-specific oral anticoagulants, direct oral anticoagulants (DOACs). The authors conclude […]

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Anticoagulant Therapy

Jan 10 2015

george

Anti-Xa AC Reversal: Phase III Results

On January 9, 2014, Portola Pharmaceuticals announced the results of their phase III trial of intravenous Andexanet Alfa, an anti-Xa reversal agent. The trial, ANNEXA-R, tested Andexanet against rivaroxaban, however subsequent trials will generalize it to the additional anti-Xa‘s apixaban and edoxaban. Dave McGlasson comments and a January 9 article appears in The Heart, which […]

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Anticoagulant Therapy

Jan 10 2015

george

FDA Clears Edoxaban

On Thursday, January 8, 2014, the FDA cleared edoxaban (Savaysa, Daiichi-Sankyo) for reducing risk of ischemic stroke in non-valvular atrial fibrillation (AFIB) and for treating DVT and PE in patients who have already been receiving an anticoagulant by injection or by infusion for 5 to 10 days. The anticoagulant joins apixaban and rivaroxaban as the […]

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Anticoagulant Therapy

Nov 21 2014

george

Coumadin and Factor Half-lives

I received a question recently about Coumadin (warfarin) therapy and coagulation factor half-lives. Coumadin reduces the normal carboxylation of the glutamic acid γ-carbon. There are 12–18 glutamic acid units near the amino terminus of the vitamin K-dependent factors II (prothrombin), VII, IX, and X. When vitamin K-catalyzed γ-carboxylation becomes suppressed, these coagulation factors are unable […]

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Anticoagulant Therapy

Nov 1 2014

george

Favorable FDA Edoxaban Vote

According to an October 30 Medscape post, Edoxaban (Savaysa, Daiichi-Sankyo) received a favorable vote, 9–1, in favor of release for once a day treatment at 30 and 60 mg to prevent non-valvular atrial fibrillation ischemic stroke. Edoxaban was found non-inferior to “in control” Coumadin in patients with mild to moderate renal impairment, but its performance in […]

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Anticoagulant Therapy

Oct 16 2014

george

Test to Assess Clotting Status

From our ASCLS Consumer Web Forum: I was wondering if there is any test available to assess the clotting status of someone with factor V Leiden genetic disorder to verify if the treatment plan has been effective? If the patient has been on anticoagulants, is there a test to prove that the blood-clotting issue has […]

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Anticoagulant Therapy

Oct 6 2014

george

New DOAC Reversal Agents

George, I noticed on Fritsma Factor the question on using Kcentra to reverse DOACs.  I just got this off Medscape on a phase 3 study of an antidote to the  factor Xa inhibitor apixaban. An IV bolus of andexanet alfa immediately and significantly reversed apixaban in 33 healthy volunteers enrolled in the ANNEXA-A study.  The authors […]

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Anticoagulant Therapy

Oct 5 2014

george

KCentra to Reverse DOACs?

From Gabor Varadi, Einstein Healthcare: Hello George, I would like to ask your opinion about using 4-component prothrombin complex concentrate (PCC) for rivaroxaban and dabigatran-induced life-threatening bleeding. Any scientific data to support using this product? Thank you. Hello, Dr. Varadi, and thank you for your question. Kcentra, from CLS Behring, has been available since 2009 under the trademark […]

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Anticoagulant Therapy

Sep 25 2014

george

Pediatric INR?

From Patti Richardson, St. Christopher’s Hospital for Children: Good afternoon, George: For critical values, are pediatric hospitals using the prothrombin time and international normalized ratio (PT & INR)? For pediatric hospitals, what is the INR critical value most often used? Hello, Patti, thank you for an excellent question. The Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American […]

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Jul 24 2014

george

Dabigatran Controversy

Here is a Medpage article that broke July 23 describing the concern that Boehringer Ingelheim may have withheld data that supported dabigatran measurement in atrial fibrillation treatment. For the details, see Reilly PA, Lehr T, Haertter S, et al. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation […]

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Anticoagulant Therapy