Dabigatran (Pradaxa®, Boehringer-Ingelheim) was approved in 2008 in Europe and Canada for prevention of venous thromboembolic disease following hip- or knee-replacement surgery and cleared by the US FDA for prevention of ischemic stroke in atrial fibrillation in October, 2010. Our latest quick question asks, how do you intend to monitor it? As you answer, if you have any comments about monitoring dabigatran, which is a direct thrombin inhibitor, or rivaroxaban (Xarelto®, Bayer and Johnson & Johnson), a direct anti-Xa anticoagulant, please attach them here.
It looks like at least two more direct anti-Xa formulations are coming soon, apixiban(Eliquis®, Pfizer and Bristol-Myers, Squibb), and edoxaban (Daiichi Sankyo Inc, recently approved in Japan), providing additional laboratory monitoring challenges. The worldwide market for oral anticoagulants is heating up.
We are also looking into a test to monitor dabigatran. We ha
We are also looking into a test to monitor dabigatran. We have been evaluating the Hemoclot Thrombin Inhibitors test from Hyphen BioMed. They also have the dabigatran calibrators and controls. The only problem we have is with billing issues.
Hi George and everyone else. The new generation of Oral Ant
Hi George and everyone else. The new generation of Oral Antithrombotic Agents (OATs) pose some new challenges to the clinical laboratory. The laboratory is stuck between the physician and their need to know how much the patient is on and the pharmaceutical company which says monitoring is unnecessary. The laboratory is also stuck between the cost cutting measures of the hospital administration and the expense of reagent test systems. A perfect test would be easy to perform in the routine coagulation laboratory, cheap and quick turn around time.
The Dilute Plasma Thrombin Time as described by Jason E. Love, Chris Ferrell and Wayne Chandler and published in Thromb Haemost 2007; 98:234-242 meets those criteria. Here is a link to their abstract: http://1.usa.gov/nM14Lq. They describe a modified Thrombin Time test to determine the therapeutic range for lepirudin, argatroban and bivalirudin.
Now the question comes to mind,Yeah, but how about Dabigatran? They also use this same modified Thrombin Time test to evaluate patients on Dabigatran. Here is the link to their website where they describe the uses of the Diluted Plasma Thrombin Time: http://uwmcacc.org/alternative_monitoring.html . One should note the specific criteria for using this test to monitor Dabigatran.
I can certainly see the value of this test in the routine coagulation laboratory. Maybe some else has experience with this testing methodology and can share their expertise.
St. Louis University Hospital Coagulation Reference Laboratory
(Thank you Herb, very helpful. Geo.)