Value through Innovation20 September 2014
20 April 2012

GLORIATM-AF Registry Program investigating use of antithrombotic therapy in 56,000 patients with atrial fibrillation at risk of stroke announced

Dubai, UAE, 20th April, 2012 – Boehringer Ingelheim announced today the launch of the GLORIATM-AF Registry Program, which is set to become the largest worldwide registry with the aim of understanding the long-term use of oral antithrombotic therapy in the prevention of non-valvular atrial fibrillation (AF)-related stroke in a real-world setting.

With up to 56,000 patients planned for enrolment across 2,200 sites in 50 countries, GLORIATM-AF will study treatment regimes available for stroke prevention in non-valvular AF and respective patient outcomes. The Registry Program will collect important data on the safety and comparative effectiveness of antithrombotic treatments, including vitamin K antagonist (VKA) warfarin, acetylsalicylic acid (ASA) and novel oral anticoagulants, such as dabigatran etexilate (Pradaxa®).

"With novel oral anticoagulants entering the market having shown convincing clinical trial data in the prevention of stroke in non-valvular AF, registries such as GLORIATM-AF are important in investigating how these trial results translate into clinical practice, and provide insight into how antithrombotic therapy can be fully optimised to ensure patients with AF at risk of stroke receive the best possible care," says Dr. Menno Huisman, Associate Professor at Leiden University Medical Center, Department of Thrombosis and Haemostasis, Netherlands and Chair of the GLORIATM-AF Registry Program.

To mirror the real-world setting, GLORIATM-AF will involve a range of clinical settings including general practices, specialist offices, community hospitals, university hospitals, outpatient care centres and anticoagulation clinics. By 2012, the registry will have started in countries of all major regions of the world, including USA, EU, Latin America and Asia with other participating countries following subsequently and completion anticipated by 2020.

Eve Knight Co-Founder and Chief Executive of AntiCoagulation Europe (ACE), UK

"The launch of the GLORIATM-AF Registry Program is exciting news and a really important step forward," says Eve Knight Co-Founder and Chief Executive of AntiCoagulation Europe (ACE), UK. "Given that AF is the most common sustained heart rhythm condition affecting over 70 million people worldwide and is associated with raising the risk of someone with AF having a stroke by five times, it is incredibly important to find out how effective and safe both old and new treatments are in protecting people from a potentially disabling and deadly stroke."

VKA therapy has been the long-time standard of care for stroke prevention in AF. While VKA therapy is very effective in reducing the risk of stroke in patients with non-valvular AF,1 there are significant challenges associated with its use, including regular monitoring, dosing adjustment and numerous drug–drug and drug–food interactions. Due to these limitations,1 only half of eligible patients (51%) receive treatment with VKA therapy2 and fewer than half of these patients are controlled within the desired therapeutic range, leading to a significant unmet need in stroke prevention in AF.3

To address the shortcomings of VKAs, several novel oral anticoagulants have been studied in late stage clinical development including factor Xa inhibitors and the direct thrombin inhibitor Pradaxa®.4 In the landmark RE-LY® trial, Pradaxa® 150mg bid compared to well-controlled warfarin (median time in therapeutic range (TTR) 67%5), was shown to be the first novel oral anticoagulant superior to well-controlled warfarin for the prevention of ischaemic and haemorrhagic stroke and systemic embolism for adult patients with non-valvular AF at risk of stroke.6,7 Pradaxa® 110mg bid, which is indicated for certain patients with non-valvular AF, was shown to be non-inferior to well-controlled warfarin for the prevention of stroke and systemic embolism.6,7 To date, Pradaxa® has been approved for the prevention of stroke in non-valvular AF in more than 70 countries worldwide.

Gregory Lip, Professor of cardiovascular medicine at University of

Gregory Lip, Professor of cardiovascular medicine at University of
Birmingham Centre for Cardiovascular Sciences, UK said, "GLORIATM-AF is a truly collaborative effort, which brings together leading experts from a number of therapy areas across the globe to gain insights into the changing landscape of stroke prevention in non-valvular AF. It is with excitement that we are anticipating presenting more details about the unique design of this Registry Program later in 2012."

NOTES TO EDITORS

About AF and stroke
AF is the most common sustained heart rhythm condition,8 with one in four adults over the age of 409 developing the condition in their lifetime. People with AF are more likely to experience blood clots, which increases the risk of stroke by five-fold.9,10 Up to three million people worldwide suffer strokes related to AF each year.11-14 Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%).15 Many AF-related strokes can be prevented with appropriate antithrombotic therapy.1 AF-related strokes currently represent a significant cost to healthcare systems across Europe. Given AF-related strokes tend to be more severe this results in direct medical patient costs which are higher than non AF-related strokes annually (€11,799 vs €8,817 P < 0.001).16

About GLORIATM-AF Registry Program

The GLORIATM-AF Registry Program is a large, international, observational study program designed to characterise newly diagnosed patients with non-valvular AF at risk of stroke. With up to 56,000 patients planned to be enrolled through 2,200 sites in up to 50 countries, GLORIATM-AF will provide insights into treatment choices of newly diagnosed patients with AF across different regions of the world.

Disease registries and observational studies are effective tools to observe the course of a disease and evaluate treatment effectiveness and safety, investigate the variations in the outcomes and to provide insight into factors that affect patient survival. This is especially important when evaluating new therapies such as novel oral anticoagulants for stroke prevention in AF.

Real-world data allow the exploration of disease management patterns, treatment safety monitoring and identification of optimisation strategies in clinical practice, which are vital for studying broad patient populations in relation to co-morbidities and co-medications.

About dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs)17 targeting a high unmet medical need in the prevention and treatment of acute and chronic thromboembolic diseases.

Potent antithrombotic effects are achieved with direct thrombin inhibitors by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for clot (thrombus) formation. In contrast to vitamin-K antagonists, which variably act via different coagulation factors, dabigatran etexilate provides effective, predictable and consistent anticoagulation with a low potential for drug-drug interactions and no drug-food interactions, without the need for routine coagulation monitoring or dose adjustment.

About the dabigatran etexilate clinical trial programme
Boehringer Ingelheim’s clinical trial programme to evaluate the efficacy and safety of dabigatran etexilate encompasses studies in:

  • Primary prevention of venous thromboembolism (VTE) in patients undergoing elective total hip and knee replacement surgery
  • Treatment of acute VTE
  • Secondary prevention of VTE
  • Stroke prevention in AF
  • Prevention of thromboembolism after heart valve replacement.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.

In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment Prescription Medicines on research and development.

Updated information on the corporation’s annual results in 2011 will be available on April 24th, 2012.

Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters in Germany. Please be aware that there may be national differences between countries regarding specific medical information, including licensed uses. Please take account of this when referring to the information provided in this document. This press release is not intended for distribution within the USA or Canada.

References
1Hart 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.
2Hylek EM, et al. Translating the results of randomized trials into clinical practice. The challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke 2006; 37:1075-80.
3Samsa GP, et al. Quality of anticoagulation management among patients with atrial fibrillation: results of a review of medical records from 2 countries. Arch Intern Med 2000; 160:967-73.
4Eikelboom J, Weitz J. A replacement for warfarin: The search continues. Circulation 2007; 116(2):131-133.
5FDA Advisory Committee Briefing Document, September 2010,http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisory Committee/UCM226009.pdf
6Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361:1139-51.
7Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med 2010; 363(19):1875-76.
8Stewart S, Murphy N, Walker A, et al. Cost of an emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart 2004; 90:286-92.
9Lloyd-Jones DM, Wang TJ, Leip EP, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation 2004; 110:1042-6.
10Fuster V, Rydn LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation – executive summary. Circulation 2006; 114:700-52.
11Kannel WB, et al. Final Draft Status of the Epidemiology of Atrial Fibrillation. Med Clin North Am. 2008; 92(1): 17–40.
12Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed Dec 2010 at www.who.int/cardiovascular_diseases/en/ cvd_atlas_15_burden_stroke.pdf .
13Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991: 22(8);983-8.
14Marini C, De Santis F, Sacco S, et al. Contribution of atrial fibrillation to incidence and outcome of ischaemic stroke: results from a population-based study. Stroke 2005; 36:1115-9.
15Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial fibrillation: the Framingham study. Stroke 1996; 27:1760-4.
16Bruggenjurgen B et al. The Impact of Atrial Fibrillation on the Cost of Stroke: The Berlin Acute Stroke Study. Value Health 2007; 10: 137–43.
17Di Nisio M, et al. Direct Thrombin Inhibitors. N Engl J Med 2005; 353:1028-40.

Media contact

  • Malin
    Boehringer Ingelheim

    Media & PR
    Dr Reinhard Malin
    Binger Strasse 173
    55216 Ingelheim am Rhein

    GERMANY

Media contact

  • Malin
    Boehringer Ingelheim

    Media & PR
    Dr Reinhard Malin
    Binger Strasse 173
    55216 Ingelheim am Rhein

    GERMANY

Prof. Gregory Lip

Teaser Prof. Lip 1

What is GLORIATM-AF Registry?

(WMV)

Prof. Gregory Lip

Teaser Prof. Lip 2

The importance of running a truly global patient registry

(WMV)

Prof. Gregory Lip

Teaser Prof. Lip 3

The importance of the GLORIATM-AF registry in light of the introduction of multiple novel oral anticoagulants

(WMV)

Prof. Gregory Lip

Teaser Prof. Lip 4

Why obtaining real-world data is so important

(WMV)