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RE-LY® Sub-Analysis Suggests Similar Safety and Efficacy With Pradaxa® (dabigatran etexilate mesylate) Versus Warfarin in NVAF Patients With and Without Diabetes
Data Presented During the American Heart Association's Scientific Sessions
By: PR Newswire
Nov. 4, 2012 06:01 PM
RIDGEFIELD, Conn., Nov. 4, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. presented study results from a new retrospective sub-analysis of the RE-LY® trial that indicated patients with non-valvular atrial fibrillation (NVAF) who also have diabetes experienced similar safety and efficacy with Pradaxa® (dabigatran etexilate mesylate) 150mg or dabigatran 110mg* relative to warfarin, in comparison to patients with NVAF who do not have diabetes. This data was presented today during the American Heart Association's Scientific Sessions 2012.
Diabetes affects 25.8 million Americans. It is one of the most common conditions associated with atrial fibrillation (AFib), and patients with both conditions have up to double the risk of experiencing a stroke compared to those with only AFib.
"These results are encouraging, as they indicate PRADAXA 150mg twice daily is effective in this higher risk NVAF patient population, a group in need of effective treatments," said Paul Reilly, PhD, clinical program director, Boehringer Ingelheim Pharmaceuticals, Inc.
Of the 18,113 patients in the RE-LY trial, 4,221 patients (23 percent) had diabetes when the trial began. This sub-analysis examined patient characteristics and outcomes of patients with NVAF, comparing those with and without diabetes, and the relative efficacy of PRADAXA 150mg twice daily or dabigatran 110mg twice daily versus warfarin, using an interaction p-value.
The results show that patients with diabetes in the RE-LY study had a higher prevalence of additional cardiovascular diseases (e.g., hypertension), and for diabetic patients with NVAF randomized to warfarin, INR was not as well-controlled. Despite this, the sub-analysis indicates that patients with NVAF and diabetes, compared to patients with NVAF without diabetes, derive similar relative outcomes from PRADAXA 150mg or dabigatran 110mg compared to warfarin.
"It is common for patients with atrial fibrillation to have co-morbidities, such as diabetes," said Harald Darius, MD, PhD, Vivantes Berlin-Neukolln Medical Center, Germany. "These findings are important and relevant since nearly one out of four patients with NVAF in the RE-LY study also had diabetes."
The sub-analysis found that patients with diabetes were younger (70.9 vs. 71.7 years, p<0.01) and more likely to have other cardiovascular diseases, including hypertension (86.6 percent vs. 76.5 percent, p<0.01), coronary artery disease (37.4 percent vs. 24.9 percent, p<0.01) and peripheral vascular disease (5.6 percent vs. 3.2 percent, p<0.01). Compared to RE-LY patients without diabetes, those with diabetes had a higher risk of strokes and major bleeds, except intracranial bleeding.
The RE-LY trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol, which has been used in the previous trials of anticoagulation for stroke prevention in patients with AFib. A PROBE design may reflect the differences in the management of warfarin and dabigatran in clinical practice.
The primary endpoint of the trial was incidence of stroke (including ischemic and hemorrhagic) and systemic embolism. The primary safety endpoint was major bleeding, defined as a reduction in the hemoglobin level of at least 2.0 g/dL, transfusion of at least 2 units of blood, or symptomatic bleeding in a critical area or organ. Other safety endpoints included bleeding events (major and minor), intracerebral hemorrhage, other intracranial hemorrhage, elevations in liver transaminases, bilirubin and hepatic dysfunction and other adverse events.
In the RE-LY trial, all clinical outcomes were adjudicated in a blinded manner to assess outcomes for each treatment.
*Although studied in the RE-LY trial, dabigatran 110mg is not approved by the U.S. FDA.
About Pradaxa® (dabigatran etexilate mesylate) Capsules
Indications and Usage
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA
WARNINGS & PRECAUTIONS
Temporary Discontinuation of PRADAXA
Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
Other Measures Evaluated
For full PRADAXA prescribing information, please visit www.pradaxa.com or contact Boehringer Ingelheim's Medical and Technical Information Unit at 1-800-542-6257.
About the Boehringer Ingelheim Cares Foundation Patient Assistance Programs
About Boehringer Ingelheim Pharmaceuticals, Inc.
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 $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
PRADAXA® is a registered trademark of Boehringer Ingelheim Pharma GmbH and Co. KG and used under license. RE-LY® is a registered service mark of Boehringer Ingelheim International GmbH and used under license.
SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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