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New Analyses of Data From RE-LY Trial, Involving Oral Anticoagulant Pradaxa, to be Presented at American Heart Association's Scientific Sessions
Date:11/11/2010

linded doses) was as effective as well-controlled warfarin – INR 2.0 - 3.0 – (open label) for stroke prevention.(1) Patients with non-valvular AFib and at least one other risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack, or systemic embolism, left ventricular dysfunction, age greater than or equal to 75 years, age greater than or equal to 65 years with either diabetes mellitus, history of coronary artery disease, or hypertension)(6) were enrolled in the study for two years with a minimum follow-up period of one year.(1)

The RE-LY® trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol,(1) which has been used in the previous trials of anticoagulation for stroke prevention in patients with AFib.(1)  A PROBE design may reflect the differences in the management of warfarin and PRADAXA in clinical practice.(1)

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(1) 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.(1)

In the RE-LY® trial, all clinical outcomes were adjudicated in a blinded manner to minimize bias in assessment of outcomes for each treatment.(1)

About Atrial Fibrillation and Stroke

Atrial fibrillation, characterized by an irregular heartbeat,(7) can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(7)  An estimated 2.3 million Americans are living with AFib,(8) and the prevalence is expected to increase to 5.6 million by 2050.(8) A large managed care database study showed that non-valvular atrial fibrillation represents approximately 95 percent of all atrial fibrillation cases in the U.S.(8)  Atrial fibrillation increases the
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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