American College of Cardiology and Boehringer Ingelheim collaborate to advance physician education

Boehringer IngelheimIn parallel with the American College of Cardiology (ACC) Scientific Sessions in San Francisco, initial results have been released from a physician educational programme being undertaken to rectify misunderstandings on stroke prevention in atrial fibrillation (AF) in China. The programme offered by the ACC and the Chinese Society of Cardiology with the support of Boehringer Ingelheim, is part of wider international educational activities. It is designed to address the current chronic under-treatment of atrial fibrillation in China and meet future needs for the prevention of AF-related strokes. Following the formation of a Steering Committee with international experts from the ACC and Chinese experts from the Chinese Society of Cardiology, foundational 'Train the Trainer' meetings were completed in early 2013. With the support of these trainers, the educational programme will now be rolled out in hospitals across China, reaching over 4,000 cardiologists during 2013.

It is estimated that there are over 8 million patients with atrial fibrillation in China, considerably more than in Europe and the US, and the number continues to rise.(1) Of these patients, currently only 10% receive any form of treatment for stroke prevention in China, far below the average treatment rates worldwide and in other parts of Asia.2 Results from the global RE-LY AF Registry have highlighted the significant need for effective stroke prevention in China, where more AF patients suffered a stroke (7.2%) versus South East Asia (6.6%) and North America (3.1%) within a one year follow-up period.(2) For this reason the American College of Cardiology, the largest non-profit medical association in cardiology, together with the Chinese Society of Cardiology, and with support from Boehringer Ingelheim, has developed an educational programme to increase the understanding of atrial fibrillation treatments and management in China.

"The first Expert Consensus on AF Anticoagulation Treatment in China has identified the importance of primary and secondary stroke prevention for patients with atrial fibrillation. Atrial fibrillation leads to a five-fold increase in the risk of stroke, especially the risk of ischaemic stroke, which accounts for 92% of all AF-related strokes," commented Prof. Dayi Hu, President of the Chinese Society of Cardiology. "There is still considerable misunderstanding amongst Chinese doctors on the role of anticoagulant treatments such as warfarin for stroke prevention in AF patients, leading to significant and widespread underuse. In light of the recent innovations in the field and the introduction of novel oral anticoagulants, physician education is even more crucial for improving patient outcomes."

Following the formation of a Steering Committee between the ACC and the Chinese Society of Cardiology, 'Train the Trainer' meetings were undertaken in January 2013 led by Professors John Camm and Elaine Hylek to build the foundation of the educational programme in China. Ten pilot centres will be set-up throughout China in 2013 offering over fifty lectures and face-to-face exchanges in hospitals with top local and global experts in AF. The contents of the lectures will be based on actual clinical practice to address the 'real needs of China'. The programme is expected to reach over 4,000 cardiologists during 2013.

"The Train the Trainer meetings have allowed us to build a firm foundation from which to undertake peer-to-peer sharing of medical knowledge, expertise and clinical skills," stated Professor John Camm, Head of the Division of Cardiac and Vascular Sciences at St. Georges Hospital, UK. "Working together we hope to standardise the care of patients with atrial fibrillation in China throughout 2013."

"The American College of Cardiology is thrilled to collaborate with the Chinese Society of Cardiology and Boehringer Ingelheim to bring physician training to our counterparts in China," said ACC President William A. Zoghbi, MD, FACC. "We hope to improve patient care and outcomes across China by working together to share our experience and expertise."

Physician education is essential to ensure appropriate and best use of treatments. With the recent addition of novel oral anticoagulants into treatment guidelines worldwide, physicians now have more options to consider for AF patients at risk of stroke.

Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim stated, "In addition to developing innovative treatment options like Pradaxa®, Boehringer Ingelheim is proud to support educational programmes across the world which help to encourage optimal management of patients with atrial fibrillation. We hope that the programme will help to advance patient care across China."

RE-LY AF Registry(2,3)
RE-LY AF is the first prospective registry to report one-year outcomes for a large cohort of primary care patients with AF from all regions of the world, including low-income countries. It is based on the clinical records of patients presenting to emergency departments with AF between January 2008 and April 2011 from academic settings, rural and urban areas in 9 major geographic regions of the world. The goals of the RE-LY AF registry, supported by Boehringer Ingelheim, are to measure worldwide variations in the predisposing conditions and treatment of AF, with a focus on blood pressure management and anticoagulation.

Stroke Prevention in Atrial Fibrillation
AF is the most common sustained heart rhythm condition(4), with one in four adults over the age of 404 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.(5) Up to three million people worldwide suffer strokes related to AF each year.(6,7) Strokes due to AF tend to be severe, with an increased likelihood of death (20%), and disability (60%).(8)

Ischaemic strokes are the most common type of AF-related stroke, accounting for 92% of strokes experienced by AF patients and frequently leading to severe debilitation.(9) Appropriate anticoagulation therapy can help to prevent many types of AF-related strokes and improve overall patient outcomes.(10) Pradaxa 150mg bid is the only novel oral anticoagulant, for which the pivotal trial* vs. warfarin (INR 2-3, median TTR 67%4) has shown a statistically significant and clinically relevant reduction of both ischaemic and haemorrhagic strokes.(11,12) Additionally, treatment with Pradaxa is associated with >2-fold lower rates of both fatal and non-fatal intracranial haemorrhage, one of the most devastating complications of anticoagulation therapy.(13,14)

Worldwide, AF is an extremely costly public health problem, with treatment costs equating to $6.65 billion in the US and over €6.2 billion across Europe each year.(15,16) Given AF-related strokes tend to be more severe, this results in higher direct medical patient costs annually.(17) The total societal burden of AF-related stroke reaches €13.5 billion per year in the European Union alone.(18)

Dabigatran etexilate
Dabigatran etexilate is at the forefront of a new generation of oral anticoagulants/direct thrombin inhibitors (DTIs) (19) 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.

To date, regulatory approvals of Pradaxa® exceed 80 countries worldwide with clinical experience continuing to grow and equating to over 1.4 million patient-years in all licensed indications, exceeding that of all other novel oral anticoagulants.(20)

About 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 44,000 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.

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 endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about 13.2 billion euro. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

About the American College of Cardiology
The mission of the American College of Cardiology is to transform cardiovascular care and improve heart health. The College is a 43,000-member medical society comprised of physicians, surgeons, nurses, physician assistants, pharmacists and practice managers. The College is a leader in the formulation of health policy, standards and guidelines. The ACC provides professional education, operates national registries to measure and improve quality of care, disseminates cardiovascular research, and bestows credentials upon cardiovascular specialists who meet stringent qualifications.

1. Hu D and Sun Y. Epidemiology, Risk Factors for Stroke, and Management of Atrial Fibrillation in China. J Am Coll Cardiol. 2008, 52:865-868.
2. Healey JS, et al. Global Variations in the 1-Year Rates of Death and Stroke in 15,340 Patients Presenting to the Emergency Department with Atrial Fibrillation in 47 Countries: The RE-LY AF Registry. Presented at the European Society of Cardiology Congress 2012, 29th August 2012.
3. Healey JS, et al. Global variation in the etiology and management of atrial fibrillation: results from a global atrial fibrillation registry- Presented at the European Society of Cardiology Congress 2011, August 2011, session number 711006.
4. Lloyd-Jones DM, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004;110:1042-6.
5. Camm JA, et al. 2012 focussed update of the ESC Guidelines for the management of atrial fibrillation. European Heart Journal. 2012;33:2719-2741
6. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed Nov 2012 at http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.pdf
7. Camm JA, et al. Guidelines for the management of atrial fibrillation. European Heart Journal. 2010;31:2369–2429.
8. Gladstone DJ, et al. Potentially Preventable Strokes in High-Risk Patients With Atrial Fibrillation Who Are Not Adequately Anticoagulated. Stroke. 2009;40:235-240.
9. Andersen KK, et al. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009;40:2068−72.
10. Aguilar 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 Systematic Reviews. 2005, Issue 3. Art. No.: CD001927.
11. Connolly SJ, et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2009;361:1139-51.
12. Connolly SJ, et al. Newly Identified Events in the RE-LY Trial. N Engl J Med. 2010;363:1875-6.
13. Hart RG, et al. Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with Warfarin or Dabigatran: The RE-LY® Trial. Stroke 2012; 43(6):1511-1517
14. Fang MC, et al. Death and disability from warfarin-associated intracranial and extracranial hemorrhages. Am J Med. 2007; 120:700 –705.
15. Coyne KS, et al. Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States. Value Health 2006; 9:348-56.
16. Ringborg A, et al. Costs of atrial fibrillation in five European countries: results from the Euro Heart Survey on atrial fibrillation. Europace 2008; 10:403-11.
17. Brüggenjürgen B, et al. The impact of atrial fibrillation on the cost of stroke: the Berlin acute stroke study. Value Health 2007;10:137-43.
18. Fuster V, et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation – executive summary. Circulation. 2006;114:700-52.
19. Di Nisio M, et al. Direct thrombin inhibitors. N Engl J Med 2005; 353:1028-40.
20. Boehringer Ingelheim Data on File.

*RE-LY® was a PROBE trial (prospective, randomized, open-label with blinded endpoint evaluation), comparing two fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110 mg bid and 150 mg bid) each administered in a blinded manner, with open label warfarin.11,12

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