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Acute deep vein thrombosis and pulmonary embolism: significantly lower clinically relevant bleeding rates for Dabigatran etexilate versus Warfarin


New pooled safety data from the RE-COVER and RE-COVER II phase III trials in acute deep vein thrombosis ( DVT ) and pulmonary embolism ( PE ) consistently favour treatment with Pradaxa ( Dabigatran etexilate ) 150mg bid over treatment with Warfarin ( Coumadin ). The data are published in Circulation.

Vitamin K antagonists ( VKAs ), the current standard of care in DVT and PE patients after an initial course of parenteral anticoagulation, are associated with multiple limitations and treatment challenges including inconvenience to both patients and physicians. Currently, Warfarin is implicated in one third of all emergency hospitalisations for adverse drug events and there is a need for alternative, safer and simpler treatment options.

RE-COVER and RE-COVER II, both global phase III randomised double-blind parallel-group studies, investigated the efficacy and safety of Dabigatran etexilate versus Warfarin for the treatment of acute deep vein thrombosis or pulmonary embolism.
Primary efficacy outcomes were recurrent symptomatic venous thromboembolism ( VTE ) and related deaths with a safety endpoint of major bleeding measured during six months of therapy. The combined studies enrolled 5,107 patients who were all initially treated with parenteral Heparin therapy and then randomised to receive Warfarin or Dabigatran etexilate.

When looking at the total treatment period including initial heparin treatment, the pooled data show a statistically significantly lower incidence of clinically relevant bleeding events ( Dabigatran etexilate 150mg vs Warfarin, hazard ratio, HR=0.62 ) and total bleeding ( Dabigatran etexilate 150mg vs Warfarin, HR=0.70 ) for patients treated with Heparin followed by Dabigatran etexilate compared to patients receiving heparin followed by Warfarin.
These data also show a trend towards reduction of major bleeding for Dabigatran etexilate ( Dabigatran etexilate 150mg 1.4% vs Warfarin 2.0% ). The primary efficacy endpoint of thromboembolism or related death was comparable between the two treatments ( Dabigatran etexilate 150mg 2.4% vs Warfarin 2.2% ).

Importantly, pooled data for the treatment period after the end of the Heparin treatment when patients were receiving only the oral study drugs ( Dabigatran etexilate or Warfarin ) show that versus Warfarin, patients treated with Dabigatran etexilate have statistically significantly lower rates of: major bleeding events ( Dabigatran 150mg vs Warfarin, HR=0.60 ); major or clinically relevant bleeding ( Dabigatran 150mg vs Warfarin, HR=0.56 ); total bleeding events ( Dabigatran 150mg vs Warfarin, HR=0.67 ). ( Xagena )

Source: Boehringer-Ingelheim, 2013

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