Boheringer Inghelim has reported 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 150mg bid over treatment with warfarin.

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 Pradaxa versus warfarin for the treatment of acute DVT or PE. 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 Pradaxa.

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 (Pradaxa 150mg vs. warfarin, HR 0.62) and total bleeding (Pradaxa 150mg vs. warfarin, HR 0.70) for patients treated with heparin followed by Pradaxa compared to patients receiving heparin followed by warfarin. These data also show a trend towards reduction of major bleeding for Pradaxa (Pradaxa 150mg 1.4% vs. warfarin 2.0%). The primary efficacy endpoint of VTE or related death was comparable between the two treatments (Pradaxa 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 (Pradaxa or warfarin) show that versus warfarin, patients treated with Pradaxa have statistically significantly lower rates of: major bleeding events (Pradaxa 150mg vs. warfarin, HR 0.60, CI 0.36-0.99); major or clinically relevant bleeding (Pradaxa 150mg vs. warfarin, HR 0.56, CI 0.45-0.71) and total bleeding events (Pradaxa 150mg vs. warfarin, HR 0.67, CI 0.59-0.77).

Sam Schulman, Professor of Hematology and Thromboembolism, Department of Medicine, McMaster University, Hamilton, Canada, said, "These latest results from the pooled analysis of the phase III trials RE-COVER and RE-COVER II reinforce that dabigatran etexilate is an effective treatment with a favourable safety profile in DVT and PE. The pooled data favour dabigatran treatment over warfarin and provide further reassurance to both physicians and patients especially regarding the safety of the treatment.”

Existing data show that in the acute treatment and prevention of recurrent DVT and PE, Pradaxa 150mg bid offers an effective and well-tolerated treatment. Pradaxa's fast onset of action, providing maximal effectiveness in less than two hours, allows for an easy transition from initial heparin treatment with no overlap in treatment required. Due to one fixed-dose treatment with Pradaxa from the beginning, patient management is simplified, as there is no need to titrate or adjust once prescribed.

Pradaxa is already widely approved for stroke prevention in atrial fibrillation and for primary prevention of VTE following total hip replacement or total knee replacement surgery. Collective clinical experience exceeds six years, with two million patient-years in all licensed indications placing Pradaxa first among the novel oral anticoagulants.

Pradaxa (dabigatran etexilate) is currently not approved for the acute treatment of DVT or PE.

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