Dabigatran
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Dabigatran
About dabigatran an oral thrombin inhibitor
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Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects.

This small study of 12 healthy volunteers looked at the reversal of anticoagulation with a preparation derived from plasma and containing Vitamin K dependent factors II, VII, IX and X that has advantages over Fresh Frozen Plasma (FFP) since it does not require ABO blood-type matching and thawing.

 

"Prothrombin complex concentrate immediately and completely reverses the anticoagulant effect of rivaroxaban in healthy subjects but has no influence on the anticoagulant action of dabigatran at the PCC dose used in this study."

 

This is to be expected since the target for dabigatran in the clotting cascade is after prothrombin (but some effect has been noted in murine models of intracranial haemorrhage). However, it identifies the lack of an immediate reversal agent for dabigatran.

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Around 260 deaths globally from bleeding related to dabigatran - NeLM

Around 260 deaths globally (post-marketing) from bleeding related to dabigatran (Pradaxa®) - figure higher than previously thought but rate below that seen in the trials.

 

A harder figure to find is the the opposite of this ... number of strokes perhaps caused by poor compliance with dabigatran when used outside the context of a trial.

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Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial FibrillationClinical Perspective

Risk of Bleeding With 2 Doses of Dabigatran Compared With Warfarin in Older and Younger Patients With Atrial FibrillationClinical Perspective | Dabigatran | Scoop.it

An Analysis of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) Trial.

 

"In patients with atrial fibrillation at risk for stroke, both doses of dabigatran compared with warfarin have lower risks of both intracranial and extracranial bleeding in patients aged <75 years. In those aged ≥75 years, intracranial bleeding risk is lower but extracranial bleeding risk is similar or higher with both doses of dabigatran compared with warfarin."

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Dabigatran - Wikipedia, the free encyclopedia

Dabigatran - Wikipedia, the free encyclopedia | Dabigatran | Scoop.it

"Dabigatran (Pradaxa in Australia, Europe and USA, Pradax in Canada, Prazaxa in Japan) is an oral anticoagulant from the class of the direct thrombin inhibitors. It is being studied for various clinical indications and in some cases it offers an alternative to warfarin as the preferred orally administered anticoagulant ("blood thinner") since it does not require frequent blood tests for international normalized ratio (INR) monitoring while offering similar results in terms of efficacy. There is no specific way to reverse the anticoagulant effect of dabigatran in the event of a major bleeding event, unlike warfarin."

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Dabigatran's First A Fib Year Starts Warfarin's Decline : Internal Medicine News

Dabigatran's First A Fib Year Starts Warfarin's Decline : Internal Medicine News | Dabigatran | Scoop.it
For decades, physicians and patients bemoaned the problems and inconveniences of warfarin to prevent strokes caused by atrial fibrillation.
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Abstract 15500: Dabigatran is Associated with Higher Risk of Myocardial Infarction or Acute Coronary Syndromes: a Meta-analysis of Non-Inferiority Randomized Controlled Trials -- Uchino and Hernand...

Abstract 15500: Dabigatran is Associated with Higher Risk of Myocardial Infarction or Acute Coronary Syndromes: a Meta-analysis of Non-Inferiority Randomized Controlled Trials -- Uchino and Hernand... | Dabigatran | Scoop.it

Systematic review by researchers at Cleveland Clinic and presented at AHA.

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Dabigatran versus Warfarin in Patients with Atrial Fibrillation — NEJM

The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial.

 

"In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage."

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Risks for Stroke, Bleeding, and Death in Patients With Atrial Fibrillation Receiving Dabigatran or Warfarin in Relation to the CHADS2 Score: A Subgroup Analysis of the RE-LY Trial

The CHADS2 score is 1 point each for Congestive heart failure, Hypertension, Age 75 years or older, and Diabetes mellitus and 2 points for Stroke.

 

Researchers looked at the CHADs scores in the RE-LY study and have released figures for the risks of major bleeding, intracranial bleeding and death in those who have anticoagulation for prophylaxis of stroke in people with AF.

http://www.annals.org/content/155/10/660.abstract

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Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses | BMJ

Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context: quantitative benefit-harm and economic analyses | BMJ | Dabigatran | Scoop.it

"This analysis supports regulatory decisions that dabigatran offers a positive benefit to harm ratio when compared with warfarin. However, no subgroup for which dabigatran 110 mg offered any clinical or economic advantage over 150 mg was identified. High dose dabigatran will be cost effective only forpatients at increased risk of stroke or for whom international normalised ratio is likely to be less well controlled."

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Dean's aggregator: Research questions for dabigatran?

How best to encourage compliance?

 

Is there a higher risk of MI or acute coronary syndrome?

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Learning the Respective Roles of Warfarin and Dabigatran to Prevent Stroke in Patients With Nonvalvular Atrial Fibrillation

Learning the Respective Roles of Warfarin and Dabigatran to Prevent Stroke in Patients With Nonvalvular Atrial Fibrillation | Dabigatran | Scoop.it

Editorial in the Annals of Internal Medicine on "the race to replace warfarin".

 

"Should dabigatran replace warfarin in patients with nonvalvular atrial fibrillation? In this issue, Oldgren and colleagues address whether outcomes with dabigatran and warfarin differ according to baseline risk for stroke and provide novel data on all-cause mortality, and Schulman and colleagues compared warfarin dosing assessment every 12 weeks versus every 4 weeks. The editorialists discuss these articles and describe how they can help physicians choose whether to use dabigatran or warfarin to reduce the risk for stroke or systemic embolism in patients with nonvalvular atrial fibrillation."

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What’s new in treating older adults?

What’s new in treating older adults? | Dabigatran | Scoop.it

"Dabigatran (Pradaxa), a direct thrombin inhibitor, may prove to be a safer alternative to warfarin (Coumadin)."

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Coagulation - Wikipedia, the free encyclopedia

Coagulation - Wikipedia, the free encyclopedia | Dabigatran | Scoop.it

Thrombin is in the final common pathway of coagulation.

 

"Thrombin has a large array of functions. Its primary role is the conversion of fibrinogen to fibrin, the building block of a hemostatic plug. In addition, it activates Factors VIII and V and their inhibitor protein C (in the presence of thrombomodulin), and it activates Factor XIII, which forms covalent bonds that crosslink the fibrin polymers that form from activated monomers."

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