Pradaxa now indicated for DVT and PE

Pradaxa (dabigatran) is now licensed for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and the prevention of recurrent DVT and PE in adults.

Only the 110mg and 150mg capsules of Pradaxa (dabigatran) are licensed for the new DVT and PE indications.
Only the 110mg and 150mg capsules of Pradaxa (dabigatran) are licensed for the new DVT and PE indications.

Dabigatran is a direct thrombin inhibitor. Like rivaroxaban and apixaban, it does not require routine dose monitoring.

Dosing

The recommended daily dose for the treatment and prevention of recurrent DVT or PE in adults is 150mg twice daily, following treatment with a parenteral anticoagulant for minimum of 5 days.

Treatment benefit and risk of bleeding should be taken into consideration when determining the duration of therapy. Treatment courses of at least 3 months should be based on transient risk factors such as recent surgery, trauma, immobilisation and those of longer durations should be based on permanent risk factors or idiopathic DVT or PE.

Treatment of DVT and PE

In two randomised, double-blind studies (RE-COVER and RE-COVER II) in patients with acute DVT and/or PE, oral dabigatran (150mg twice daily) was non-inferior to warfarin in reducing the occurrence of the primary endpoint (defined as a composite of recurrent symptomatic DVT and/or PE and related deaths within the 6-month treatment period).

Prevention of recurrent DVT and PE

Two randomised, double-blind studies enrolled patients previously treated with anticoagulation therapy, warfarin for 3 to 12 months in RE-MEDY and vitamin K inhibitors for 6 to 18 months in RE-SONATE.

Dabigatran 150mg twice daily was superior to its comparators in both studies for the prevention of recurrent symptomatic DVT or PE events: warfarin (HR 1.44, 95% CI 0.78-2.64, p=0.01) and placebo (HR 0.08, 95% CI 0.02-0.25, p<0.0001) .

Existing indications

Dabigatran is also licensed for the prevention of venous thromboembolic events in adults who have undergone elective total hip or knee replacement surgery (75mg and 110mg capsules only), and for stroke prevention in patients with atrial fibrillation and ≥1 additional risk factor (110mg and 150mg capsules only).

View Pradaxa drug record

Further information: Boehringer Ingelheim

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