• GLORIA™-AF Registry Programme shows half of patients in China with an irregular heart beat (atrial fibrillation, or AF) suboptimally protected against potentially devastating stroke1 • Treatment guidelines recommend preventative treatment with anticoagulants over antiplatelets (such as ASA*) for AF patients at risk of stroke**2,3 • GLORIA™-AF Registry Programme will enrol up to 56,000 patients in 50 countries4
For media outside of the U.S., the UK & Canada only
Ingelheim, Germany, 7 May, 2014 – Boehringer Ingelheim today announces first worldwide data from the GLORIA™-AF Registry Programme highlighting substantial regional differences in how patients with an irregular heart beat (atrial fibrillation, or AF) were treated with stroke prevention medicines. Data collected from nine countries over one and a half years (May 2011-January 2013) before the approval of novel oral anticoagulants4 show that a large proportion of patients with atrial fibrillation at risk of stroke were treated with antiplatelet therapy, such as ASA*, or did not receive any stroke prevention treatment at all. These patients were at increased risk of suffering a disabling or fatal stroke. The data were presented today at the World Heart Federation's World Congress of Cardiology Scientific Sessions 2014 in Melbourne, Australia.1
Patients with atrial fibrillation, the most common heart rhythm disorder worldwide, are at five-times higher risk of stroke if not appropriately treated.2,5 Blood-thinners are essential for stroke prevention in these patients.6,7 Latest treatment guidelines recommend that AF patients deemed at risk of stroke** should take warfarin or a novel oral anticoagulant (NOAC), rather than less effective antiplatelet therapies such as ASA*.2,3 Warfarin has a narrow therapeutic window and administration limitations, leading to significant underuse in some regions of the world and leaving many AF patients inadequately protected against stroke.8
The results from the first phase of the GLORIA™-AF Registry Programme were collected prior to the availability of novel oral anticoagulants in the participating countries. 1,063 newly diagnosed AF patients with a moderate to high risk of stroke were enrolled globally with results demonstrating:1
The majority of enrolled patients should have received stroke prevention treatment as they were deemed at moderate or high risk of stroke (CHA2DS2-VASc≥2). Despite this, 1 in 4 (25.9%) patients in China received no antithrombotic therapy compared to only 8.6% in Europe
Most patients in China were treated with antiplatelet therapy (53.7%) versus 27.1% in Europe
Use of warfarin is lowest in China and highest in Europe
Nearly two thirds (63.9%) of AF patients in Europe received warfarin compared to only 20.3% in China
Overall warfarin was most frequently prescribed for patients at high risk of stroke (36.1%, CHA2DS2-VASc≥2) versus those deemed at moderate risk of stroke (20.1%, CHA2DS2-VASc=1)
"These data show that more patients with atrial fibrillation in China were at potentially increased risk of stroke compared to Europe due to no treatment or lower usage of effective anticoagulants," said Professor Chang-Sheng Ma, Professor and Department Chair, Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, China and member of the GLORIA™-AF Steering Committee. "The ongoing publication of results from the GLORIA™-AF Registry Programme will help physicians, especially those based in China, to recognise that the gap between prescribing patterns in China compared to other parts of the world needs to be bridged. We look forward to future results which will enable us to advance management of atrial fibrillation and to ultimately better protect patients against a potentially devastating stroke wherever in the world they live."
Boehringer Ingelheim launched the GLORIA™-AF Registry Programme, the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation, to provide important scientific information from everyday clinical practice on antithrombotic prescribing patterns and patient outcomes. GLORIA™-AF which will enrol up to 56, 000 patients in 50 countries, is set to become one of the largest AF registries worldwide.4 Patient enrolment into the registry programme has now commenced in all major regions of the world with over 11,000 patients already participating in the registry.9
The GLORIA™-AF Registry Programme 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® (dabigatran etexilate), the first NOAC for stroke prevention, to patients with atrial fibrillation.10 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.9,11-22 Clinical experience with Pradaxa® continues to grow worldwide and currently equates to over 2.9 million patient-years in all licensed indications supporting Pradaxa® as the leading novel oral anticoagulant.9
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.4
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.4 Patient enrolment into the registry programme has now commenced in all major regions of the world with over 11,000 patients already participating in the registry.9
For more information please visit
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.
References 1Huisman M.V. et al. Results of the 1st Phase of the International GLORIA-AF Registry Program: Regional Treatment Differences Before the Era of Novel Anticoagulants. Oral Presentation on Wednesday 7 May 2014 at the World Heart Federation’s World Congress of Cardiology Scientific Sessions 2014, Melbourne, Australia. 2Camm AJ, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33(21):2719-47. 3January CT, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary : A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. JACC. 2014. DOI: 10.1016/j.jacc.2014.03.021 4Huisman 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. 5Lloyd-Jones DM, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110(9):1042-46. 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. 8Camm AJ, et al. Guidelines for the management of atrial fibrillation. Eur Heart J. 2010;31(19):2369–429. 9Boehringer Ingelheim data on file. 10Pradaxa® European Summary of Product Characteristics 2014. 11Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51. 12Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6. 13Ezekowitz MD, et al. RE-LY and RELY-ABLE Long-term Follow-up of Patients with Non-valvular Atrial Fibrillation Receiving Dabigatran Etexilate for up to 6.7 Years. Oral Presentation #10684 on Monday 18 November 2013 at the American Heart Association Scientific Sessions, Dallas, Texas, USA. 14Connolly 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. 15Eriksson 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. 16Eriksson 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. 17Eriksson 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. 18Ginsberg 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;24:1–9. 19Schulman S, et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52. 20Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation. Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation published online before print December 16, 2013, doi:10.1161/ CIRCULATIONAHA.113.004450 21Schulman S, et al. Extended use of dabigatran, warfarin or placebo in venous thromboembolism. N Engl J Med. 2013;368:709–18. 22Oldgren 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.