Extensive experience in clinical practice and expanding research programme support use of Pradaxa® for clot prevention

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• Recent analysis of real world data document again the positive safety and efficacy profile of Pradaxa® as proven in clinical trials1-3
• Final Phase of GLORIA™-AF Registry Program now initiated in North America and Europe
• Extensive clinical research in established and new indications underway to improve patient care with Pradaxa®

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

Ingelheim, Germany, 1 September 2014 – Five years on from the first breakthrough presentation of the pivotal RE-LY® clinical trial of Pradaxa® (dabigatran etexilate) for the prevention of stroke in non-valvular atrial fibrillation (NVAF),4 extensive clinical trial and real-world data support Pradaxa® in various indications.1-12 Boehringer Ingelheim continues to grow the evidence base for Pradaxa® to improve care for patients at risk of blood clots and today announces the initiation of Phase III of the GLORIATM-AF registry program in North America and in Europe. During this final phase of the registry program, data on the overall safety and effectiveness of antithrombotic treatments will be collected.13

"The body of evidence supporting Pradaxa®, based on clinical trials, analyses of large real-world databases and different regulatory assessments since the RE-LY® trial was first presented, is both robust and consistent" said Professor Jörg Kreuzer, Therapeutic Area Head Cardiovascular Medicine, Boehringer Ingelheim. "And we will continue our research both in clinical trials and in clinical practice to further strengthen this evidence base for Pradaxa® to support the confident use of our treatment by physicians and patients, so that patients can receive the best possible care."

The extensive research programme by Boehringer Ingelheim for Pradaxa®, aimed at deepening the science behind effective clot prevention and providing support for everyday patient management, will eventually include over 100,000 patients.4-19 The research programme covers both clinical studies and analyses of everyday clinical practice and includes the GLORIA™-AF registry, the recently announced RE-CIRCUIT™, RE-DUAL PCI™ and RE-SPECT ESUS™* studies for Pradaxa®†, and the RE-VERSE AD™ trial to investigate the antidote idarucizumab‡ in the clinical setting in patients taking Pradaxa®.4-19

Beyond the Boehringer Ingelheim research programme, independent studies have been conducted that support the efficacy and safety profile of Pradaxa®.1-3 The U.S. Food and Drug Administration recently reinforced the favourable efficacy and safety profile of Pradaxa® based upon a large analysis of Medicare data.§3 The analysis involved 134,000 patients, 65 years or older and its findings were consistent with results of the clinical RE-LY® trial that supported the global approval of Pradaxa® for stroke prevention in non-valvular atrial fibrillation.3-5 The study found that, among new users of blood-thinning drugs, Pradaxa® was associated with a similar risk of myocardial infarction (MI) compared to warfarin and an increased risk of major gastrointestinal (GI) bleeding, just like in RE-LY®.3-5 But most importantly, the study also showed that with Pradaxa®, there was a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin treatment.3

*Dabigatran etexilate is not approved in any country for patients with ESUS.
†The new trial announcements have not received indication approvals.
‡Idarucizumab is the recommended International Nonproprietary Name (INN). The antidote is still under investigation and has not yet been approved for clinical use.
§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 non-valvular AF.20 The dose of 75mg twice daily is not authorised in Europe for this indication.21

For further media information including backgrounders please visit: www.newshome.com. Abstracts are available from the ESC website at: http://spo.escardio.org/default.aspx?eevtid=69

RE-VERSE AD™, a global patient study, is now underway to investigate idarucizumab in the clinical setting in patients taking Pradaxa®. This is the first time that an antidote under development for a novel oral anticoagulant is investigated in a pivotal patient study. The first study sites in Europe have been initiated, and more sites and countries will follow during the course of 2014.19

GLORIA™-AF is a large, multinational, prospective registry program designed to investigate patient characteristics influencing choice of antithrombotic treatment for stroke prevention in atrial fibrillation (AF). The registry program will use outcome data from clinical practice to provide valuable insights on the overall safety and effectiveness of antithrombotic treatments.13

The latest data from Phase II of GLORIA™-AF were presented in a Registry Hot Line session at the ESC Congress 2014. The results from the first 10,000 patients in Phase II showed that even despite the availability of the novel oral anticoagulants as alternatives to warfarin, there are still too many patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke who remain undertreated and do not receive adequate treatment to protect them from stroke. While the data are encouraging, and show in some regions (North America and Europe) increasing uptake of NOACs and preference over vitamin k antagonists (VKAs, such as warfarin), high proportions of patients remain undertreated with acetylsalicylic acid (ASA) only, or receive no treatment. This is most pronounced in Asia, but also prevalent in North America.22

New studies on Pradaxa®
For information on new studies with Pradaxa®, please visit www.newshome.com.

About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) equates to 2.4 million patient-years in all licensed indications worldwide.23 Pradaxa® has been in the market for more than 6 years and is approved in over 100 countries.

Currently approved indications for Pradaxa® are:20,21

  • 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.21,24 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.25 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.24,26

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.

1European Medicines Agency Press Release - 25 May 2012: EMA/337406/2012. European Medicines Agency updates patient and prescriber information for Pradaxa. http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/05/news_detail_001518.jsp&mid=WC0b01ac058004d5c1 Last accessed August 2014.
2Southworth MR. et al. Dabigatran and postmarketing reports of bleeding. N Engl J Med. 2013;368:1272-4.
3FDA 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 August 2014.
4Connolly SJ. et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
5Connolly SJ. et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
6Connolly 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.
7Eriksson 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.
8Eriksson BI. et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II). A randomised, doubleblind, non-inferiority trial. Thromb Haemost. 2011;105:721-9.
9Eriksson BI. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. Thromb Haemost. 2007;5:2178–85.
10Schulman S. et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
11Schulman S. et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014;129:764-772.
12Schulman S. et al. Extended use of dabigatran, warfarin or placebo in venous thromboembolism. N Engl J Med. 2013;368:709–18.
13GLORIA-AF Registry website. https://www.gloria-af.com/public/about-objectives.html Last accessed August 2014.
14Oldgren J. et al. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial.Eur Heart J. 2011;32:2781-9.
15Ginsberg JS. et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthoplasty. 2009;24(1):1–9.
16Diener H-C. et al. Rationale, objectives and design of a secondary stroke prevention study of dabigatran etexilate versus acetylsalicylic acid in patients with embolic stroke of undetermined source (RE-SPECT-ESUS). Presented at the European Stroke Conference, Nice, France on 7 May 2014, 12:45-14:15 PM.
17Clinical Trials.gov. Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting. http://clinicaltrials.gov/ct2/show/NCT02164864?term=dabigatran+etexilate&recr=Open&rank=6 Last accessed August 2014.
18Boehringer Ingelheim Press Release - New Pradaxa® clinical study to explore practical management of patients with atrial fibrillation undergoing ablation. http://www.newshome.com/diru/news_releases/press_releases/2014/20_june_2014_dabigatranetexilate.html Last accessed August 2014.
19Boehringer Ingelheim Press Release – 22 May 2014. Antidote for rapid reversal of Pradaxa® (dabigatran etexilate) progresses into next stage of clinical investigation with study in patients. http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/22_may_2014_dabigatranetexilate.html Last accessed August 2014.
20PRADAXA® Prescribing Information, 2014.
21Pradaxa® European Summary of Product Characteristics, 2014.
22Huisman M. Global registry on long-term oral antithrombotic treatment in patients with atrial fibrillation: baseline characteristics of the first 10,000 patients in GLORIA-AF Phase II. Hot Line Session. Presentation #896 - Registry Hot Line: Atrial fibrillation and myocardial infarction on 31 August 2014 at the ESC Congress 2014, Barcelona, Spain.
23Internal calculations based on IMS Health monthly Dataview database – April 2014 Update.
24Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
25Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
26Stangier 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.

¥ In Spain these indications are pending for price and reimbursement. En España el precio y las condiciones de financiación de esta indicación se hallan pendientes de tramitación.

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