Dabigatran-etexilate is a prodrug that rapid after intake converts to the active dabigatran, which is a trombininhibitor. It is used to prevent formation of thrombus in adults, who had a total hip or a knee replacement.
Dabigatran-etexilat requires no monitoring or dose adjustment during treatment.
Dabigatran-etexilat is found equal in comparison with the low molecular heparin enoxaparin.
The most frequent side effects in dabigatran-etexilate treatment are bleeding, which happens in 14 % of the patients among these 2 % are severe bleeding that is at the same level as in treatment with enoxparin.
In total knee replacement the treatment is recommended in 10 days after operation and in total hip replacement the treatment is recommended in 28 – 35 days.
In Denmark the standard treatment with low molecular heparin is 7 – 10 days which depends on the degree of mobilisation during hospitalisation.
In Danish Orthopaedic Society reference program about total hip and knee replacements it is pointed out, that everyone must have thrombosis prophylaxis before operation. Meta analyses based on former studies have shown that a prolonged thrombosis prophylaxis with a low molecular heparin (28 – 35 days) is efficient in reducing the occurrence of both asymptomatic and symptomatic thrombosis emboli.
The treatment with dabigatran-etexilate in 30 days costs 1.372,55 DKr. The treatment with low molecular heparin costs 1.281 – 1695 Dkr. The price per day is on the whole identical for dabigatran-etexilat and low molecular heparin.
IRF states that treatment with dabigatran-etexilate and low molecular heparin are equal.
Pradaxa was marketed the 2nd of June 2008.