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Biochemistry of Dabigatran
- Molecular mass: 623 D
- Plasma half-life: 13-18h
- Peak plasma time: 2-3h after oral administration
- Bioavailability: 6.5 %
- Composition: Dabigatran etexilate is a prodrug that exerts its anticoagulant effect by conversion to dabigatran
Clinical Aspects of Dabigatran
Dabigatran (Pradaxa®) is a direct reversible thrombin inhibitor. The applied drug is dabigatran etexilate, having no anticoagulant activity. After oral application dabigatran etexilate is rapidly absorbed and, via esterase-catalyzed hydrolysis in plasma and in the liver, converted into the active form dabigatran.
The use of dabigatran generally requires no routine monitoring of the inhibition of coagulation. The measurement of anticoagulant activity in conjunction with dabigatran may however be useful to avoid an excessively high exposure to dabigatran in the presence of additional risk factors.
To assess the status of anticoagulation during treatment with dabigatran semi-quantitative chemical laboratory coagulation assays (aPTT, ECT and thrombin time) are available. An exact determination of the concentration should be carried out by a modified thrombin time (e.g. Technoclot® DTI). In this assay, plasma spiked with dabigatran should be used for generation of a standard curve. A plasma concentration of about 200ng/ml, measured 10-16 hours after the last intake of dabigatran indicates an increased bleeding risk.
Clinical or Research use of Dabigatran
- To reduce the risk of strike and systemic embolism in subjects with non-valvular atrial fibrillation
- For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in subjects who have been treated with a parenteral anticoagulant for 5-10 days
- To reduce the risk of recurrence of DVT and PE in subjects who have been previously treated
- For the prophylaxis of DVT and PE in subjects who have undergone hip replacement surgery
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