A new oral direct thrombin inhibitor Pradaxa® (dabigatran etexilate) was launched in the UK today.
It is approved for the prevention of venous thromboembolic events (VTE) in adults who have undergone elective total hip or total knee replacement surgery.
More information here.
European approval was based on data from the phase III RE-NOVATE and RE-MODEL studies, which indicated that both 150mg and 220mg of Pradaxa were as effective and safe as injectable enoxaparin (40 mg) in preventing VTE and all cause mortality following total hip replacement surgery and total knee replacement surgery in the RE-NOVATE and RE-MODEL trials, respectively.
Both studies reported a low incidence and severity of major bleeding, similar to enoxaparin. In addition, the rates of ALT elevations > 3x times the upper limit of normal were reported to be low and comparable to enoxaparin.
The PR flaks were hard a work.
It made the BBC Breakfast TV show.
And a charity was there ready to welcome it.
The UK charity Lifeblood's medical director, Dr Beverley Hunt, said: "The prevention of blood clots with blood thinners after surgery is not done well in the UK."
"The need for and potential impact of a generally well-tolerated oral anticoagulant that does not require monitoring is profound."
Here's what they're saying about it on their website.
Hmmmm. Watch this space.
No comments:
Post a Comment