1 • The Registry Programme will enrol up to 56,000 patients in nearly 50 countries to investigate patient characteristics influencing prescribing choice and to assess the relative long-term effectiveness and safety profile of Pradaxa® (dabigatran etexilate) vs. warfarin1 • Innovative three-phase design of GLORIA™-AF now published in the American Heart Journal1
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Ingelheim, Germany, 11th March 2014 – Boehringer Ingelheim today announces the enrolment of the 10,000th patient with atrial fibrillation (AF) into GLORIA™-AF, one of the largest AF registry programmes currently running worldwide.2 GLORIA™-AF, the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation, is part of Boehringer Ingelheim's ongoing commitment to optimising stroke prevention in atrial fibrillation. The registry will provide important information from everyday clinical practice on antithrombotic prescribing patterns and patient outcomes. Additionally, the registry is expected to provide valuable insight into how antithrombotic therapy can be further optimised to ensure patients with AF receive the best possible protection from a potentially disabling or deadly stroke. The innovative three-phase design of GLORIA™-AF, published in the March issue of the American Heart Journal, will help to collect useful data on the effectiveness and safety of Pradaxa® (dabigatran etexilate) versus warfarin and allow for the assessment of changes in prescribing patterns of antithrombotic therapies over time and across different regions of the world.1
Atrial fibrillation is the most common sustained heart rhythm disorder worldwide, increasing patients’ risk of stroke five-fold.3,4 Strokes due to AF tend to be especially severe and disabling, with half of the people dying within 12 months.5,6 Antithrombotics are essential for the prevention of AF-related stroke, the primary goal of treatment in patients with AF.6,7 The GLORIA™-AF Registry Program has been designed to increase understanding of patient characteristics influencing choice of antithrombotic treatment, such as comorbidities and concurrent medications. GLORIA™-AF will involve up to 56,000 patients newly diagnosed with AF at risk of stroke from nearly 50 countries worldwide. The registry programme will report patient outcome data that will assist in the evaluation of how antithrombotic therapies are used in the real world for the prevention of AF-related stroke.1
"The introduction of new antithrombotics has changed prescribing patterns for stroke prevention in atrial fibrillation worldwide," said Dr. Menno Huisman, Professor of Medicine at Leiden University Medical Center, Department of Thrombosis and Haemostasis, The Netherlands and Chair of the GLORIA™-AF Registry Programme. "Large registries such as GLORIA™-AF provide physicians with invaluable insights from outside the context of clinical trials. The knowledge that will be gained from GLORIA™-AF will help physicians to choose the best possible treatment for their patients with atrial fibrillation to ensure effective stroke prevention."
GLORIA™-AF adopted a novel three-phase design. The Registry Programme is run in different phases, with useful information being collected to assess changes in prescribing patterns of antithrombotic therapies over time and across different regions of the world. The knowledge that will be shared throughout the registry programme will advance the management of AF in clinical practice.1
Phase I was undertaken to collect information on antithrombotic prescribing patterns prior to the approval of novel oral anticoagulants (NOACs) in many countries worldwide, enrolling patients from May 2011 to January 20131
Phase II, which began after the approval of the first novel oral anticoagulant Pradaxa® in November 2011, collects data on the safety of the treatment as well as the baseline characteristics of patients treated with Pradaxa® or warfarin1
Phase III starts when there is sufficient overlap of patient characteristics between Pradaxa® and warfarin treatment groups. Phase III will follow patients for three years to evaluate the effectiveness and safety of Pradaxa® versus warfarin using patient outcome data. Information regarding the overall safety and effectiveness of other antithrombotic treatments will also be collected1
To mirror the real-world setting, GLORIA™-AF will include patients newly diagnosed with AF from multiple clinical settings including general practices, specialist offices, community and university hospitals, outpatient care centres and anticoagulation clinics. Knowledge will be gained from patients treated with a variety of therapies including warfarin and NOACs, as recommended in treatment guidelines for protection against the devastating consequences of AF-related stroke. Additionally data will be collected from patients prescribed acetylsalicylic acid (ASA) or no antithrombotic treatment.1 Patient enrolment into the registry has commenced in all major regions of the world including Europe, North America, Latin America and Asia with the first global results expected to be announced in the first half of 2014.2
GLORIA™-AF is just one part of Boehringer Ingelheim's ongoing commitment to advancing stroke prevention in atrial fibrillation. Boehringer Ingelheim led the anticoagulant field by bringing Pradaxa®, the first NOAC for stroke prevention in atrial fibrillation, to market. The efficacy and safety profile of Pradaxa® is well documented in the extensive RE-VOLUTION® clinical trial programme which has led to regulatory approvals in over 100 countries to date.2 Clinical experience with Pradaxa® continues to grow worldwide and currently equates to over 2.7 million patient-years in all licensed indications, supporting Pradaxa® as the leading novel oral anticoagulant.2
NOTES TO THE EDITORS
GLORIA™-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) GLORIA™-AF is a large, multinational, prospective registry programme designed to investigate patient characteristics influencing choice of antithrombotic treatment for stroke prevention in atrial fibrillation (AF). The registry will use outcome data from clinical practice to provide valuable insights on the effectiveness and safety profile of Pradaxa® versus warfarin. With up to 56,000 patients newly diagnosed with non-valvular AF at risk of stroke planned to be enrolled in up to 2,200 sites in nearly 50 countries, GLORIA™-AF will be one of the largest registries in atrial fibrillation.1
GLORIA™-AF will report patient outcome data that will assist in the evaluation of how antithrombotic therapies are used in the real world for the prevention of AF-related stroke. Patient enrolment into the registry programme has commenced in all major regions of the world with first global results expected to be announced in the first half of 2014.2
Boehringer Ingelheim The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. 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 endeavors.
In 2012, Boehringer Ingelheim achieved net sales of about 14.7 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 22.5% of its net sales.
References 1Huisman M.V. et al. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: A global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014;167:329-34. 2Boehringer Ingelheim data on file. 3Lloyd-Jones DM, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042-46. 4Camm AJ, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33(21):2719-47. 5Gladstone DJ, et al. Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated. Stroke. 2009;40(1):235-40. 6Marini C, et al. From a Population-Based Study Contribution of Atrial Fibrillation to Incidence and Outcome of Ischemic Stroke: Results From a Population-Based Study. Stroke. 2005;36:1115-9. 7Aguilar MI, Hart R. Oral anticoagulants for preventing stroke in patients with non-valvular atrial fibrillation and no previous history of stroke or transient ischemic attacks. Cochrane Database of Syst Rev. 2005;(3):CD001927.