Two new, large scale real-world analyses show fewer major bleeds and strokes with Pradaxa® than with warfarin

Boehringer IngelheimTwo new real-world data analyses presented at the American Heart Association's Scientific Sessions 2014 independently demonstrate that routine treatment with Pradaxa® (dabigatran etexilate) was associated with fewer major bleeds and strokes compared to warfarin.(1,2) The results of both studies, which involved over 60,000 atrial fibrillation (AF) patients in the US, demonstrate that the safety and effectiveness profile of Pradaxa® treatment seen during the RE-LY® clinical trial can be achieved in broad patient populations receiving routine clinical care for stroke prevention.(1-4) One analysis was conducted by the Brigham and Women's Hospital, using commercial US health insurance databases,(1) and the second analysis was conducted by the Walter Reed National Military Medical Center, using the US Department of Defense Military Health System database.(2) In the US, the licensed doses for dabigatran etexilate are 150mg twice daily and 75mg* twice daily to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.(5)

Interim findings from Dr. John D. Seeger from the Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, show that treatment with Pradaxa® led to a significant 25 per cent reduction of major bleeding compared to warfarin and a numerical 23 per cent reduction in strokes. The data were derived from 38,378 AF patients in two commercial US health insurance databases (MarketScan and Optum).(1)

Similar results were seen in the second real-world study presented at the congress by Lieutenant Colonel Todd C. Villines, Cardiology Service, Walter Reed National Military Medical Center. Treatment with Pradaxa® was associated with significantly fewer strokes (27 per cent less) and fewer major bleeds (13 per cent less, numerically) than warfarin treatment. In addition, significantly more major lower gastrointestinal bleeding (30 per cent more), significantly fewer myocardial infarctions (35 per cent less), and a significantly improved survival (36 per cent better) were observed in patients taking Pradaxa®. The data were analysed from the US Department of Defense Military Health System database and included over 25,000 AF patients.(2)

"Real-world data are extremely valuable to physicians as they provide insights on how the efficacy-safety profile of a medicine is reflected in different patient populations in general practice," said Prof. Jörg Kreuzer, Practicing Cardiologist and Vice President Medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim. "We are pleased by these latest results as they show that the safety and efficacy profile of Pradaxa® originally established in the RE-LY® clinical trial can also be achieved in routine care worldwide."

The results from the two new studies presented at the American Heart Association's Scientific Sessions 2014 show a similar pattern to the real-world results from the recent Medicare assessment published by the U.S. Food and Drug Administration (FDA) which included more than 134,000 AF patients who were 65 years of age or older. All three large real-world analyses which involved a total of over 190,000 AF patients from different populations reaffirm the efficacy and safety profile of Pradaxa® for stroke prevention over warfarin in everyday routine care.(1,2,7)

About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) equates to over 3 million patient-years in all licensed indications worldwide. Pradaxa® has been in the market for more than 6 years and is approved in over 100 countries.(8)

Currently approved indications for Pradaxa® are:(5,6)

  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and a risk factor for stroke
  • Primary prevention of venous thromboembolic events in patients undergoing elective total hip replacement surgery or total knee replacement surgery
  • Treatment of DVT and PE and the prevention of recurrent DVT and recurrent PE in adults

Pradaxa®, a direct thrombin inhibitor (DTI), was the first widely approved drug in a new generation of direct oral anticoagulants, available to target a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.(9) Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin, the central enzyme in the process responsible for clot (thrombus) formation.(10) In contrast to vitamin-K antagonists, which variably act via different coagulation factors, Pradaxa® provides effective, predictable and reproducible anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or mandatory dose adjustment.(9,11)

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

* In the US, 75mg twice daily is indicated for patients with a creatinine clearance between 30 and 15 ml/min.5 The dose of 75mg twice daily is not authorised in Europe for this indication.(6)

1.Seeger JD. et al. Safety and effectiveness of dabigatran relative to warfarin in routine care. Presented on 18th November at the American Heart Association Scientific Sessions 2014, Chicago, USA. Available at: http://www.abstractsonline.com/pp8/#!/3547/presentation/41579
2.Villines TC. et al. The Comparative Safety and Effectiveness of the Oral Anticoagulant (OAC) Dabigatran versus Warfarin Utilized in a Large Healthcare System in Non-valvular Atrial Fibrillation (NVAF) Patients. Presented on 17th November at the American Heart Association Scientific Sessions 2014, Chicago, USA. Available at: http://www.abstractsonline.com/pp8/#!/3547/presentation/37812
3.Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
4.Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
5.PRADAXA® US Prescribing Information, 2014.
6.Pradaxa® European Summary of Product Characteristics, 2014.
7.Graham J. et al. Cardiovascular, bleeding, and mortality risks in elderly medicare patients treated with dabigatran or warfarin for non-valvular atrial fibrillation. Circulation. 2014. doi: 10.1161/CIRCULATIONAHA.114.012061 Published online October 30, 2014.
8.Boehringer Ingelheim data on file.
9.Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
10.Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
11.Stangier J. et al. Pharmacokinetic Profile of the Oral Direct Thrombin Inhibitor Dabigatran Etexilate in Healthy Volunteers and Patients Undergoing Total Hip Replacement. J Clin Pharmacol. 2005;45:555–63.

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