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dabigatran Etexilate (Pradaxa)

Advice

Following a full submission

dabigatran etexilate (Pradaxa) is accepted for use within NHS Scotland for the primary prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

In two large phase lll studies, in patients undergoing either total knee or total hip replacement surgery, dabigatran was non-inferior to low molecular weight heparin in the incidence of VTE and all cause mortality with patients having a similar incidence of major bleeding events. The two drugs have similar costs per dose but dabigatran has lower administration costs and is an oral therapy. This may facilitate longer duration of thromboprophylaxis, however the risks and benefits of this longer treatment duration need to be considered on a case-by-case basis.

Drug Details

Drug Name: dabigatran Etexilate (Pradaxa)
SMC Drug ID: 466/08
Manufacturer: Boehringer Ingelheim Ltd
Indication: Primary prevention of venous thromboembolic events in adult patients who have undergone total hip replacement surgery or total knee replacement surgery
BNF Category:
Sub Category: 2.8 Anticoagulants and protamine
Submission Type: Full submission
Status: Accepted
Date Advice Published: 9 June 2008

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