Latest research on Dabigatran

Dabigatran etexilate is an oral prodrug that is metabolized by a serum esterase to dabigatran. It is a synthetic, competitive and reversible direct thrombin inhibitor. Inhibition of thrombin disrupts the coagulation cascade and inhibits the formation of clots. Dabigatran etexilate may be used to decrease the risk of venous thromboembolic events in patients who have undergone total hip or knee replacement surgery, or to prevent stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation therapy is indicated. In contrast to warfarin, because its anticoagulant effects are predictable, lab monitoring is not necessary. FDA approved on October 19, 2010.

Latest findings

Patients in the NOAC group were prescribed Dabigatran (n=99; 70.2%), rivaroxaban (n=18; 12.8%), or apixaban (n=24; 17.0%). [source, 2016]
Therefore, selection bias could have influenced the association found between anticoagulant selection and the absence of renal disease since those who may have had an absolute contraindication to Dabigatran (i.e. creatinine clearance < 30 ml/min) were included in the study. [source, 2016]
The other case involved Boehringer Ingelheim disregarding MHRA advice to remove information about Pradaxa (dabigatran) trials outside the authorized indications in promotional material. [source, 2016]
Idarucizumab has an extremely high affinity for Dabigatran (nearly 350 times stronger than dabigatran’s affinity for thrombin), and is able to reverse dabigatran’s anticoagulant effects at a 1:1 stoichiometric ratio. [source, 2016]
In one modelling analysis with CHA2DS2-VASc = 1, apixaban and both doses of Dabigatran (110 mg and 150 mg bid) have a positive NCB. [source, 2016]
Ciraparantag binds non-covalently to anticoagulants, inhibiting the anticoagulant effects of low molecular weight heparins, fondaparinux, oral FXa inhibitors and Dabigatran (Greinacher et al., 2015). [source, 2016]
Thirty of 1274 patients on Dabigatran (2.4 %) and 27 of 1265 Warfarin recipients (2.1 %) suffered recurrent VTE (0.4 % absolute risk difference; 95 % CI for non-inferiority −0.8 to 1.5). [source, 2016]
Major bleeding occurred in 20 patients assigned to Dabigatran (1.6 %) and in 24 patients taking Warfarin (1.9 %) for a hazard ratio with Dabigatran of 0.82 (95 % CI 0.42–1.48) (Table 13). [source, 2016]
In this era of newer anticoagulants that carry lower risk of intracranial bleeding while offering excellent anticoagulation, 2 large randomized trials comparing Dabigatran (RESPECT-ESUS) and rivaroxaban (NAVIGATE) with Aspirin in this population are currently underway. [source, 2016]
There was significantly more gastrointestinal bleeding in ROCKET AF and the higher dose of Dabigatran (randomised evaluation of long-term anticoagulant therapy, RE-LY) and a non-significant trend towards harm in the higher dose edoxaban (ENGAGE TIMI AF 48) and lower dose Dabigatran (RE-LY). [source, 2016]