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Boehringer Ingelheim to Launch RE-ALIGN™ Trial to Evaluate Dabigatran Etexilate in Patients with Mechanical Heart Valves
Date:8/26/2011

than 50 years to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and is sold under the brand name Pradaxa®.(8) In the first eight months after approval, nearly 300,000 patients in the U.S. were prescribed PRADAXA.(9)  

"PRADAXA has almost a full year of clinical use for the reduction of stroke risk in patients with non-valvular atrial fibrillation," said Chris Barrett, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "We continue to see a steady growth in the number of patients treated with PRADAXA and are proud of the widespread formulary coverage that has been achieved, providing access to 90 percent of covered lives in the U.S."

Findings from the Phase III RE-LY® trial showed that PRADAXA 150mg taken twice daily significantly reduced stroke and systemic embolism by 35 percent beyond the reduction achieved with warfarin (dosed to international normalized ratio (INR) 2.0 to 3.0, mean time in therapeutic range = 64.4 percent)(8) in patients with NVAF.(8) Effects of PRADAXA were more apparent in patients with lower levels of INR control.(8)  Dabigatran is recommended in an update to atrial fibrillation treatment guidelines.  

About RE-LY

RE-LY was a global, Phase III, randomized trial of 18,113 patients(8) enrolled in 951 centers in 44 countries,(10) investigating whether dabigatran etexilate (two blinded doses) was as effective as well-controlled warfarin - INR 2.0 - 3.0 - (open label) for stroke prevention.(8)  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) were enrolled in the study for two years(8) with a minimum fol
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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