FDA affirms superiority of Pradaxa® (dabigatran etexilate) 150mg over warfarin in reduction of both ischaemic and haemorrhagic strokes

Posted: 6 June 2012 | | No comments yet

Boehringer Ingelheim has updated the US prescribing information for Pradaxa®…

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Boehringer Ingelheim has today announced that it has updated the US prescribing information for Pradaxa® (dabigatran etexilate) in alignment with the US Food and Drug Administration (FDA) to affirm that “Pradaxa® 150mg twice daily was superior in reducing ischemic and hemorrhagic strokes relative to warfarin.”1 This positive change to the US label is based upon the results of the pivotal RE-LY® trial conducted in 18,000 patients with non-valvular atrial fibrillation, which demonstrated unequivocally the superior benefits offered by Pradaxa® in terms of effective prevention of stroke. In addition, RE-LY demonstrated a significant benefit vs. well controlled warfarin in life-threatening bleeding events, and major reductions in intracranial bleeding. 2,3,‡

“Ischaemic strokes account for up to 92% of strokes suffered by patients with atrial fibrillation, often leading to severe debilitation and poor prognosis,” said Hans-Christoph Diener, M.D., Ph.D., Professor and Chairman, Department of Neurology, University Duisburg-Essen, Germany. “For patients with atrial fibrillation, reducing the risk of stroke, especially ischaemic stroke, is the primary goal of anticoagulation treatment. It is important for both physicians and patients to have a treatment option that offers this decisive clinical benefit over warfarin when considering long term prevention from stroke.”

Pradaxa® 150mg bid is the only novel oral anticoagulant which has shown in a major study a significant reduction of both ischaemic and haemorrhagic strokes in patients with non-valvular atrial fibrillation when compared to warfarin. 2,3 The RE-LY® trial showed that Pradaxa® 150mg bid reduced the risk of stroke and systemic embolism by 35% compared to well-controlled warfarin (INR 2-3, median TTR 67%4). 2,3 Furthermore, Pradaxa® 110mg bid, which is indicated for certain patients, was shown to be as effective as well-controlled warfarin in the prevention of stroke and systemic embolism, while being associated with significantly lower major bleeding events in patients with non-valvular AF. RE-LY® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin. 2,3

“We welcome this update to the US prescribing information for Pradaxa® which clearly demonstrates the unique benefit offered by this novel treatment to patients and physicians worldwide,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “By significantly reducing both ischaemic and haemorrhagic strokes, and at the same time providing significant reductions in intracranial bleeding, Pradaxa® 150mg twice daily has the potential to protect patients from catastrophic events better than warfarin.”

The effectiveness and favourable safety profile of Pradaxa® has been well documented in an extensive clinical trial programme 2-7, passing independent regulatory scrutiny and approval worldwide. Clinical experience of Pradaxa® is already well established and continues to grow, equating to over 780,000 patient years in over 70 countries 8 and exceeding that of all other novel oral anticoagulants. 9 The launch of Pradaxa® has been the most successful in the history of Boehringer Ingelheim and is among the pharmaceutical industry’s top launches in the last decade.

Boehringer Ingelheim remains focused on both patients’ benefit and safety and is further investigating the profile of Pradaxa® in the long-term safety study RELY-ABLE, the results of which will be presented later this year. Additionally, Boehringer Ingelheim recently launched Phase II of the GLORIA-AF patient registry, which is designed to gain insights into the use of antithrombotic treatments in clinical practice to reduce the risk of stroke in patients with non-valvular atrial fibrillation


  1. Pradaxa US Prescribing Information. 2012.
  2. Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361:1139-51.
  3. Connolly SJ, et al. Newly identified events in the RE-LY® trial. N Engl J Med 2010; 363(19):1875-6.
  4. Pradaxa®, European Summary of Product Characteristics, 2012.
  5. Schulman S, et al. Dabigatran etexilate versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009; 361:2342-52.
  6. Eriksson BI, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007; 5:2178–85.
  7. Eriksson BI, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007; 370: 949–56.
  8. Data on file.
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  13. Global Atlas on Cardiovascular Disease Prevention and Control, World Health Organization in collaboration with the World Heart Federation and the World Stroke Organization 2011. Viewed May 2012 at
  14. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed Dec 2010 at cvd_atlas_15_burden_stroke.pdf .
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  17. Lin HJ, et al. Stroke severity in atrial fibrillation: the Framingham study. Stroke 1996; 27:1760-4.
  18. Hart RG, et al. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have non-valvular atrial fibrillation. Ann Intern Med 2007; 146:857-67.
  19. Bruggenjurgen B, et al. The Impact of Atrial Fibrillation on the Cost of Stroke: The Berlin Acute Stroke Study. Value Health 2007; 10: 137–43.
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‡ RE-LY® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.

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