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Boehringer Ingelheim Plans to Launch U.S. Registry to Assess the State of Anticoagulation Therapy for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation

Retrospective Analysis Presented at 58th Annual Scientific Session of the American College of Cardiology Suggests Oral Anticoagulants are Underused in Eligible Patients with Non-Valvular Atrial Fibrillation at Risk for Stroke

RIDGEFIELD, Conn., March 31 /PRNewswire/ -- Boehringer Ingelheim today announced that it plans to launch REAL-AF (Registry to Evaluate AnticoaguLation in Atrial Fibrillation), a U.S. based registry to evaluate patterns in the present practice of anticoagulation in 2,500 patients with non-valvular atrial fibrillation (AF).(1) The registry, which will be led by an outside committee of expert advisers,(1) will enroll patients prospectively and analyze data from patients retrospectively.(1)

Atrial fibrillation is the most common abnormal rhythm of the heart and affects more than 2.2 million Americans.(2) Atrial fibrillation can lead to serious health complications such as stroke.(2) In fact, AF is associated with a five-fold increase in the risk of stroke(3) and is associated with up to one out of every six strokes in the U.S.(2) Furthermore, AF-related strokes are often more severe and debilitating than other types.(4,5)

"Stroke can be a serious consequence of atrial fibrillation, particularly among older patients, yet evidence from several analyses suggests that many patients are not receiving anticoagulation for stroke prevention," said Dr. Giora Davidai, executive director and cardiovascular medical leader, Boehringer Ingelheim. "Through this registry, Boehringer Ingelheim hopes to better understand the factors contributing to under-treatment in this patient population."

REAL-AF Registry

Anticoagulant therapy is the most effective approach for stroke prevention in AF, reducing the incidence of stroke by up to 60 percent.(6) However, there is a need for accurate data to define the patterns of current use and management of anticoagulation in patients with AF who are treated in ordinary community medical practices.

In this registry, Boehringer Ingelheim plans to enroll 1,500 AF patients prospectively at roughly 250 general and cardiology practices across the country.(1) In addition, retrospective data will be analyzed from 1,000 patients from the same clinical sites.(1) The registry is designed to provide a better understanding of patient characteristics and risk factors, clinical outcomes (e.g., ischemic stroke, other thromboembolic events and bleeding) and healthcare resource utilization associated with the initiation of anticoagulation treatment in non-valvular AF.(1)

Analyses of retrospective data, including a medical claims database review presented today at the 58th Annual Scientific Session of the American College of Cardiology (ACC) in Orlando, FL, suggest that many patients with AF who are potentially eligible for anticoagulation therapy for stroke prevention are not treated.(7,8) The data from REAL-AF should contribute to our understanding of current treatment trends.

Claims Database Review

A Boehringer Ingelheim sponsored, retrospective analysis of medical claims from a nationally representative group of U.S. managed care plans (from January 2001 to December 2006), was presented today at ACC. The analysis of data from more than 50,000 patients with atrial fibrillation not associated with valvular disease found that less than half (41.9%) of patients potentially eligible for anticoagulation therapy for stroke prevention received it.(7) Patients were considered eligible for anticoagulant therapy if they were at moderate to high risk for stroke and lacked any evidence of contraindication to treatment.(7)

"This medical claims database review found that anticoagulation therapy was not used as widely or effectively as it could have been for stroke prevention in atrial fibrillation patients," said Dr. Gregory P. Samsa, associate professor at Duke University Medical Center and co-investigator of the study. "These results are consistent with several other analyses showing that many atrial fibrillation patients who are at increased risk for stroke do not receive treatment with anticoagulants."

About Atrial Fibrillation

Atrial fibrillation is a disorder in which the normally regular and coordinated contraction pattern of the heart's two small upper chambers (the atria) becomes irregular and uncoordinated. The contraction pattern associated with AF causes blood to pool up in the atria predisposing to formation of clots, which may escape from the heart and become lodged in the arteries leading to the brain and other organs blocking necessary blood flow. Many people with the disorder do not experience any symptoms but some may feel heart palpitations, shortness of breath, dizziness or fatigue.(9)

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies. The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and approximately 39,800 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.

In 2007, Boehringer Ingelheim posted net sales of U.S. $15.0 billion (10.9 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

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(1) Disease Registry Protocol: A Registry for the Evaluation of Safety, Health Economic and Quality of Life Outcomes in Patients with Atrial Fibrillation Newly Managed with Warfarin.

(2) Fuster V, Ryden LE, Asinger RW et al. "ACC/AHA/ESC Guidelines 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 European Society of Cardiology Committee for Practice Guidelines and Policy Conferences (Committee to Develop Guidelines for the Management of Patients With Atrial Fibrillation) Developed in Collaboration with the North American Society of Pacing and Electrophysiology." Circulation 2001;104:2118-2150.

(3) American Heart Association. "2008 Heart Disease and Stroke Statistics." Accessed on: March 11, 2009.

(4) Lin HJ, Wolf P, DJ, Bui E, Kelly-Hayes M, et al. "Stroke Prevention in Atrial Fibrillation: The Framingham Study." Stroke. 1996;27:1760-1764.

(5) Dulli D, Stanko H, DJ Levine R. "Atrial Fibrillation is Associated with Severe Ischemic Stroke." Neuroepidemiology. 2003; 22: 118-123.

(6) Hart, et al. "Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation." Annals of Internal Medicine. 146(2007); 857-867.

(7) Williams C, Reynolds M, et al. "The Extent of Warfarin Use and its Effectiveness within Atrial Fibrillation Patients from a US Nationally Representative Sample."

(8) Tapson V, Hayers T, Waldo A, et al. "Antithrombotic Therapy Practices in US Hospitals in an Era of Practice Guidelines." Archives of Internal Medicine 2005; 165:1458-1464.

(9) National Heart, Lung and Blood Institute Web site. "What is Atrial Fibrillation?" Available at: Accessed on: March 11, 2009.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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