FDA Medicare study in 134,000 atrial fibrillation patients confirms positive safety profile and effectiveness of Pradaxa® in general practice

Non-US/Non-UK/Non-Canadian Media

  • Full results of large-scale FDA Medicare study now published in Circulation reinforce positive safety and efficacy profile of Pradaxa®1
  • Study of 134,000 patients demonstrates benefits such as a significantly reduced risk of ischaemic stroke, a threefold lower rate of intracranial bleeding, and a significant survival benefit with Pradaxa® vs warfarin1
  • Data are remarkably consistent with RE-LY® study findings, which established the positive benefit-risk profile of Pradaxa® for stroke prevention in AF1-3

Ingelheim, Germany, 3 November 2014 – On October 30, 2014, the U.S. Food and Drug Administration (FDA) Medicare analysis of 134,000 atrial fibrillation (AF) patients treated with either Pradaxa(dabigatran etexilate) or warfarin in a general practice setting, was published in Circulation.1 The FDA authors conclude that dabigatran was associated with a significantly reduced risk of ischaemic stroke and intracranial bleeding, a significantly increased risk of major gastrointestinal bleeding and a significant survival benefit compared with warfarin in elderly patients with non-valvular AF.1 The FDA study confirms findings of the RE-LY study in 18,000 patients, which led to the approval of Pradaxa for stroke prevention in AF worldwide.1-3

The FDA Medicare analysis is based on patient data from elderly patients enrolled in Medicare.1 The FDA study included patients who started treatment for dabigatran or warfarin for non-valvular AF between October 2010 and December 2012 and were older than 65 years.1

The detailed results of the analysis showed:a

• Fewer ischaemic strokes due to blood clots with Pradaxa (20 per cent less than with warfarin)
• Fewer intracranial bleeds with Pradaxa (66 per cent less than warfarin)
• Survival benefit with Pradaxa (14 per cent better than warfarin)
• No difference in major bleeding between Pradaxa and warfarin
• No difference in acute myocardial infarction between Pradaxa and warfarin
• More gastrointestinal bleeding with Pradaxa (28 per cent more than warfarin)1

The U.S. FDA had already communicated part of its analysis in a Drug Safety Communication on its website in May 2014 and explicitly stated that, “Pradaxa provides an important health benefit when used as directed.”4

“The results of the U.S. FDA Medicare analysis clearly confirm that the positive safety and efficacy profile observed in the clinical RE-LY study was also achieved in real world general practice”, commented Professor Jörg Kreuzer, Vice President Medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim. “The results of this study, which is by far the largest of its kind, further reinforce the quality and reliability of RE-LY study results and the value Pradaxa can bring to patients with atrial fibrillation at risk of stroke.”

NOTES TO THE EDITORS

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.5

Currently approved indications for Pradaxa are:6,7

  • 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 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.7,8 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.9 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.8,10

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.

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Footnotes

a In the United States, the licensed doses for dabigatran etexilate are 150mg twice daily and 75mg twice daily for the prevention of stroke and systemic embolism in adult patients with NVAF. This dose of 75mg twice daily is not authorised in Europe for this indication.

Referências

  1. 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.
  2. Connolly SJ. et al. The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study. Circulation. 2013;128:237-43.
  3. Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
  4. FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin – 13 May 2014.http://www.fda.gov/drugs/drugsafety/ucm396470.htm. Last accessed: October 2014
  5. Boehringer Ingelheim data on file.
  6. PRADAXA Prescribing Information, 2014.
  7. Pradaxa® European Summary of Product Characteristics, 2014.
  8. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
  9. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
  10. 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.