Pradaxa

28 May 2008

Pradaxa (dabigatran etexilate) is the first oral direct thrombin inhibitor, indicated for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip or knee replacement surgery.

PHARMACOLOGY

After oral administration, dabigatran etexilate is rapidly absorbed and converted to its active form dabigatran, which inhibits both free and clot-bound thrombin.

Thrombin enables the conversion of fibrinogen to fibrin during the coagulation cascade; its inhibition prevents the development of thrombus

CLINICAL STUDIES
In two phase III studies,^1,2 once-daily oral dabigatran was non-inferior to subcutaneous enoxaparin once daily in the prevention of venous thromboembolism (VTE) and all-cause mortality in patients undergoing major joint replacement surgery. Both treatments had a similar safety profile.

In one of the studies,¹ once-daily dabigatran was given for 6–10 days after total knee replacement surgery. In the other study,² involving patients undergoing hip replacement surgery, treatment was continued for 28–35 days

REFERENCES
1. Eriksson BI, Dahl OE, Rosencher N, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007: 5; 2178–2185.
2. Eriksson BI, Dahl OE, Rosencher N, et al. Dabigatran etexilate versus enoxaparin for prevention of venous
thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007: 370; 949–56.

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Further information: Boehringer