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.
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Medicine details
- Medicine name:
- dabigatran Etexilate (Pradaxa)
- SMC ID:
- 466/08
- Indication:
- Primary prevention of venous thromboembolic events in adult patients who have undergone total hip replacement surgery or total knee replacement surgery
- Pharmaceutical company
- Boehringer Ingelheim Ltd
- BNF chapter
- Cardiovascular system
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 09 June 2008