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Final Patient Completes Treatment In Boehringer Ingelheim's RE-LY(R) Study, The Largest Atrial Fibrillation Outcomes Trial To Date
Date:3/20/2009

urrent standard therapy for stroke prevention in patients with atrial fibrillation.(4)

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 chaotic contraction pattern associated with atrial fibrillation 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 have any symptoms but some may feel heart palpitations, shortness of breath, dizziness or fatigue.(5)

About the RE-LY(R) Study

RE-LY(R) investigated whether dabigatran etexilate (two blinded doses) is effective for stroke prevention in patients with non-valvular AF and at least one other major risk factor for stroke (i.e., previous stroke, transient ischemic attack, heart failure, diabetes, high blood pressure or age greater than or equal to 75). Patients enrolled in the study were followed for a minimum of one year.

The primary outcome of the trial is the combined incidence of stroke (including hemorrhagic) and non-CNS systemic embolism. Secondary outcomes include all death, incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction and vascular death (including death from bleeding). Additional safety endpoints include major and minor bleeding events (including intracerebral hemorrhage).

About the Dabigatran Clinical Trial Program

RE-LY(R) is part of Boehringer Ingelheim's large clinical development program to evaluate the efficacy and safety of dabigatran etexilate against current standard therapies in over 38,000 patients. In addition to RE-LY(R), the development program encompas
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SOURCE Boehringer Ingelheim
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