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How can we monitor Dabigatran effects ?

Dabigatran, like argatroban, does prolong the prothrombin time (PT) and partial thromboplastin time (PTT). It also prolongs the thrombin time (TT), which means it  generates a false decrease in fibrinogen assay results, given that the fibrinogen assay is based on the TT. Dabigatran’s plasma concentration peaks about two hours after the drug is taken, and its half-life is 12 to 17 hours, so the PT, PTT, and fibrinogen assays should be made at least 24 hours after discontinuing dabigatran. Biophen’s Hemoclot Thrombin Inhibitor allows exploration of all the direct anti-thrombin inhibitors (DTI), targeted to human thrombin.

The Dabigatran revolution is soon to come attached the Giacalone 2011 comment letter from our group.

From Louisiana a new survey on dabigatran published on circulation in january : Dabigatran is a reasonable alternative to warfarin in patients requiring cardioversion.

Current Issue Volume 9, Issue 12 (December, 2010) Issue Contents: (Pages 1139-1232)

Because of the necessary trade-off between stroke prevention and bleeding with both doses of dabigatran, consultation with patients regarding their preferences for treatment dose will be even more important to ascertain their threshold for stroke prevention over increased bleeding risk or vice versa.

The Italian guidelines for stroke SPREAD (sponsored by Bayer health care) reported dabigatran as a safe alternative to warfarin. This is a sort of vital validation for the molecule since almost nothing can be done in stroke medicine without the  SPREAD committee approval at a national level. At a national level also the Mario Negri istitute for pharmacology gave its valuable opinion on Pradaxa.

From Manchester (UK) a meta-analysis reporting how dabigatran may be more effective than aspirin/placebo  in reducing risk of stroke, systemic embolization and mortality in AF… see on Thrombosis anf Haemostasis Oct issue

Recently reported the first case of ischemic stroke succesfully treated with endovenous thrombolysis during dabigatran treatment.
The patients was included in the RELY trial and suffered of a severe ischemic stroke with an NIH stroke scale of 19.
He successfully recovered after the rTPA infusion within 3 hours from onset according to the SITS ISTR standards.
…Intravenous Thrombolysis with Recombinant Tissue Plasminogen Activator in a Stroke Patient Treated with Dabigatran
De Smedt, A. ; De Raedt, S. ; Nieboer, K. ; De Keyser, J. ; Brouns, R.
Cerebrovasc Dis 2010;30:533-534 here Free Access

on 30 August 2010

Ingelheim, Germany – Report: The European Society of Cardiology (ESC) today issued a revised version of  guidelines for the management of atrial fibrillation (AF), including guidance on the role of thge new oral treatment, dabigatran etexilate, for the prevention of embolism in patients with atrial fibrillation (AF).

At the same time, Boehringer Ingelheim confirms that Food and Drug Administration (FDA) granted a priority review designation for Boehringer Ingelheim’s novel oral direct thrombin inhibitor (DTI) dabigatran etexilate for the prevention of stroke in AF. A priority review designation is given to new drugs that are expected to offer large advances in treatment, or provide a treatment where no adequate therapy exists. An FDA advisory committee will meet on Monday, September 20th, to review and discuss dabigatran etexilate data.

In addition to the US, the registration process for dabigatran etexilate is underway in EU, Japan and other countries. The company expects to receive a marketing authorization for dabigatran etexilate in first countries by end of 2010 or beginning of 2011. The drug availability was expected according to many opinions in fall winter 2010. Similar molecules are expected also by other companies. For people with AF, it is the first competitor to warfarin that is likely to be marketed for stroke prevention, although caution is still urged by reviewers. Stay tuned….