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Data From Largest Stroke Prevention Trial in Atrial Fibrillation To Premiere at European Society of Cardiology Congress
Date:8/25/2009

trolled warfarin - INR 2.0-3.0 - (open label) for stroke prevention.(1) Patients with non-valvular AF 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)(1) were enrolled in the study for two years with a minimum follow-up period of one year.(1)

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(10) Secondary outcome measures included a composite of incidence of stroke (including hemorrhagic), systemic embolism and all death, as well as a composite of incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, and vascular death (including death from bleeding).(10) Additional 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)

About AF and stroke

Atrial fibrillation is the most common heart rhythm abnormality in the U.S.,(11) accounting for one out of every three hospitalizations for irregular heart beat.(11) The prevalence of atrial fibrillation in the U.S. is expected to increase 2.5 fold to 5.6 million by 2050, reflecting the growing population of elderly individuals.(2) Atrial fibrillation is the cause of up to one out of every six strokes in the U.S.(11) Strokes related to AF are twice as likely to be fatal(12) and twice as likely to be debilitating as non-AF related strokes.(13) Total annual costs for the treatment of AF are estimated to be more than U.S. $6.65 billion.(14)

About dabigatran etexilate

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SOURCE Boehringer Ingelheim Pharmaceuticals
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