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- New analyses highlight undertreatment of high-risk AF patients1,2
- First Phase II data demonstrating anticoagulant prescribing patterns in North America now available from GLORIA™-AF Registry Program
- Results presented at American College of Cardiology 64th Annual Scientific Session & Expo (ACC.15)
Ingelheim, Germany, 18-3-2015 — /EuropaWire/ — Boehringer Ingelheim today announces two analyses from the GLORIA™-AF Registry Program examining the use of anticoagulant treatments for stroke prevention in patients with atrial fibrillation (AF).1,2 These new analyses found that although oral anticoagulant use is increasing in the US, approximately a fifth of North American AF patients in the GLORIA™-AF Registry Program were either inadequately treated with the antiplatelet acetylsalicylic acid (ASA) or did not receive any treatment at all.1,2 This is despite current US guidelines stating that AF patients with a CHA2DS2-VASc score of 2 or above are considered at high risk for stroke and require anticoagulant treatment.3The new findings will be presented during poster sessions at the American College of Cardiology 64thAnnual Scientific Session & Expo on 16 March 2015, San Diego, USA.
“These real-world analyses highlight that while physicians have a variety of factors to consider when deciding on antithrombotic treatment options for AF patients, the fact remains that oral anticoagulants, the standard of care for significantly reducing the risk of stroke and systemic embolism in these patients, are underutilized,” said Jonathan L. Halperin, M.D., the Robert and Harriet Heilbrunn Professor of Medicine at Mount Sinai School of Medicine, lead author of the study, and member of the GLORIA-AF steering committee. “We need to continue to uncover why that is and what we can do to bridge that treatment gap.”
The new data are the first reported prescribing patterns from Phase II of the GLORIA™-AF Registry Program, which began in November 2011 after the first novel oral anticoagulant (NOAC), Pradaxa®(dabigatran etexilate), was approved in the US. The data is based on treatment trends in 3,415 AF patients who entered the GLORIA™-AF registry from November 2011 to February 2014.1,2 All patients had a recent diagnosis of AF and 86 per cent had a CHA2DS2-VASc score of 2 or higher, placing them at high risk of stroke.1,2 The data show that dabigatran etexilate was the most widely prescribed NOAC for stroke prevention among the patients included in the study.1,2
“We still face challenges in ensuring that patients with atrial fibrillation receive the most effective anticoagulant treatment to reduce their risk of stroke, which can be debilitating or even fatal,” said Professor Jörg Kreuzer, Vice President Medicine Therapeutic Area Cardiovascular, Boehringer Ingelheim. “These latest data from GLORIA™-AF, as well as further analyses from the registry, will shed light on the strategies needed to eliminate disparities in treatment and ensure that all patients are optimally protected against stroke”.
Poster Presentation Details
March 16, 9:45-10:30 a.m. Pacific Time
Session: 1246 – Risk Assessment, Exercise and Atrial Fibrillation
- Patterns of newly detected atrial fibrillation and antithrombotic treatment in North America (GLORIA™-AF Phase II)
Authors: Halperin JL, Huisman M, Diener H-C, et al. [Poster 1246-124]
Results demonstrated that 21.9 per cent of patients with occasional AF and a CHA2DS2-VASc score of 2 or higher were either undertreated with acetylsalicylic acid (ASA) or given no anticoagulant treatment at all*, compared to 12.4 per cent and 11.2 per cent of those diagnosed with persistent or permanent AF, respectively.1 Current AF guidelines call for patients to receive oral anticoagulant therapy based on their risk of stroke, rather than their type of AF.3,4 Furthermore, given the availability of NOACs, guidelines state that the use of antiplatelet therapies (such as ASA) for stroke prevention in AF should be limited to the few patients who refuse any form of oral anticoagulant as the evidence for effective stroke prevention from ASA is weak, with a potential for harm.3,4
March 16, 9:45-10:30 a.m. Pacific Time
Session: 1246 – Risk Assessment, Exercise and Atrial Fibrillation
- Antithrombotic treatment in relation to age in patients with newly diagnosed atrial fibrillation in North America (GLORIA™-AF Phase II)
Authors: Halperin JL, Huisman M, Diener H-C, et al. [Poster 1246-122]
The second study, which grouped patients by their age and CHA2DS2-VASc score, found that about 20 per cent of new-onset AF patients below 75 years with a CHA2DS2-VASc score of 2 or higher received ASA alone or went untreated (20.6 per cent of patients aged below 65 years and 19.7 per cent of patients aged 65-74 years).2 Over half of patients were prescribed NOACs for stroke prevention, (25 per cent dabigatran, 20.5 per cent rivaroxaban, and 6.6 per cent apixaban).2 Vitamin K antagonists (VKAs e.g. warfarin) remain widely used, particularly in high-risk, elderly patients (31.7 per cent of patients aged 80 and older with a CHA2DS2-VASc score of 2 or higher).2
NOTES TO THE EDITORS
About GLORIA™-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation)
GLORIA™-AF is the largest, global observational study to date on the use of anticoagulants in patients with AF. GLORIA™-AF will examine physicians’ actual prescribing behaviours in treating AF, as well as the factors behind their prescribing decisions.5 The study will collect long-term effectiveness and safety data on a range of anticoagulants, including warfarin, ASA, and NOACs for stroke prevention in AF, as well as patient outcomes data.5
The registry will enroll up to 56,000 patients newly diagnosed with AF at risk of stroke from up to 2,200 sites in nearly 50 countries.5 Patient enrolment into the registry program has now commenced in all major regions of the world with over 20,000 patients already participating in the registry. Phase II began after the first NOAC, Pradaxa® (dabigatran etexilate), was approved in November 2011 in the US.6
For more information please visit https://www.gloria-af.com/public/about.html
CHA2DS2-VASc is a scoring system used by physicians to assess the risk of stroke in people diagnosed with AF. The system scores 1 point for: age 65-74, congestive heart failure, high blood pressure, diabetes, vascular disease, and being female, and 2 points for: age 75 and over and previous stroke/ mini-stroke or thromboembolism (blood clot blocking a blood vessel).
European guidelines recommend that anyone with a score of 1 or over should be considered for oral anticoagulant treatment with the exception of women aged < 65 and who have lone AF because their score of 1 is due to their gender.4
European and US guidelines state that anticoagulant treatment is recommended for all AF patients with a score of 2 or higher except where this is contraindicated.3,4
About Pradaxa® (dabigatran etexilate)
Clinical experience of Pradaxa® (dabigatran etexilate) equates to over 3.9 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.7
Currently approved indications for Pradaxa® are: 8, 9
- 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.10 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.11 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.10,12
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.
* The analysis defined oral anticoagulation as treatment from warfarin or the novel oral anticoagulants (dabigatran etexilate, rivaroxaban or apixaban)
1. Halperin JL, et al. Patterns of newly detected atrial fibrillation and antithrombotic treatment in North America (GLORIA-AF Phase II). Abstract No./Poster No: 1246-124, Presented at: the American College of Cardiology 64th; Annual Scientific Session (ACC.15), March 14-16, 2015, San Diego, CA.
2. Halperin JL, et al. Antithrombotic Treatment in Relation to Age in Patients with Newly Diagnosed Atrial Fibrillation in North America (GLORIA-AF Phase II). Abstract No./Poster No: 1246-122, Presented at: the American College of Cardiology 64th; Annual Scientific Session (ACC.15), March 14-16, 2015, San Diego, CA.
3. January 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. Circulation. 2014 Dec 2;130(23):2071-104.
4. Camm AJ, et al. Guidelines for the management of atrial fibrillation. The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31(19):2369–2429.
5. GLORIA-AF Registry website. www.gloria-af.com, last accessed march 2015
6. Huisman 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.
7. Boehringer Ingelheim Data on File.
8. Pradaxa® European Summary of Product Characteristics, 2014.
9. PRADAXA® US Prescribing Information, 2014.
10. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008;47(5):285–95.
11. Di Nisio M. et al. Direct thrombin inhibitors. N Engl J Med. 2005;353:1028–40.
12. 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.