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New Sub-Analysis of RE-LY Trial Examines Pradaxa in Patients with Atrial Fibrillation Undergoing Cardioversion
Date:1/5/2011

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)(2) were enrolled in the study for two years with a minimum follow-up period of one year.(4) RE-LY enrolled a comparable number of patients in each stroke risk group,(5) providing a broad representation of patients with NVAF.

The RE-LY® trial utilized the established PROBE (prospective, randomized, open-label, blinded endpoint evaluation) clinical trial protocol,(4) which has been used in the previous trials of anticoagulation for stroke prevention in patients with AFib.(4)  A PROBE design may reflect the differences in the management of warfarin and PRADAXA in clinical practice.(4)

The primary endpoint of the trial was incidence of stroke (including hemorrhagic) and systemic embolism.(4) 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.(4)

In the RE-LY® trial, all clinical outcomes were adjudicated in a blinded manner to minimize bias in assessment of outcomes for each treatment.(4)

About Atrial Fibrillation and Stroke

Atrial fibrillation, characterized by an irregular heartbeat, can cause blood clots to form in the heart that can travel to the brain and cause a stroke.(6)  An estimated 2.3 million Americans are living with atrial fibrillation,(7) and the prevalence is expected to increase to 5.6 million by 2050.(7) A large managed care database study showed that NVAF represents approximately 95 percent of all atrial fibrillation cases in the U.S.(7)  Atrial fibrillation increases the risk of stroke nearly five times(8) and is associated with up to 15 percent of all strokes in the U.S.(8) Atrial fibrillation impo
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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Related medicine technology :

1. New PLATO Sub-Analysis of CABG Patients Presented at ACC
2. Boehringer Ingelheim Announces Enrollment is Complete for the Largest Atrial Fibrillation Outcomes Trial - The RE-LY(TM) Study
3. Data Published in The Lancet Compare Dabigatran Etexilate to Dose-Adjusted Warfarin Across RE-LY® Trial Centers
4. New Analyses of Data From RE-LY Trial, Involving Oral Anticoagulant Pradaxa, to be Presented at American Heart Associations Scientific Sessions
5. Progen Engages Leading CRO to Assist with Phase 3 Trial of PI-88
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
8. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
9. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
10. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
11. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
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