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Boehringer Ingelheim Pharmaceuticals, Inc. Statement on RE-ALIGN Data
Date:8/31/2013

RIDGEFIELD, Conn., Sept. 1, 2013 /PRNewswire/ -- Today, data from the RE-ALIGN™ trial of dabigatran etexilate mesylate in patients with mechanical prosthetic heart valves were presented at the European Society of Cardiology (ESC) congress in Amsterdam, Netherlands, and published online in the New England Journal of Medicine. As part of Boehringer Ingelheim Pharmaceuticals, Inc.'s ongoing commitment to transparency, we previously announced on December 11, 2012, that this trial had been discontinued based on interim results which showed an increased incidence of thromboembolic and bleeding events in patients treated with dabigatran compared to warfarin. The RE-ALIGN study did not enroll any U.S. patients.

On December 19, 2012, the U.S. prescribing information for Pradaxa® (dabigatran etexilate mesylate) capsules was updated to include a contraindication, as well as a warning and precaution related to its use in patients with prosthetic heart valves. At that time, Boehringer Ingelheim instructed all investigators in the RE-ALIGN trial to switch patients treated with dabigatran in the study to warfarin. In addition, Boehringer Ingelheim sent letters to healthcare professionals in the U.S. informing them of the contraindication in the updated U.S. label.

"RE-ALIGN was the first, and remains the only, randomized study performed comparing a new oral anticoagulant with warfarin in patients with mechanical prosthetic heart valves. Our commitment to studying populations with unmet needs, such as those with mechanical prosthetic heart valves, serves to expand the body of knowledge around this novel compound and this patient population," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, U.S. Regional Medical Director, Boehringer Ingelheim Pharmaceuticals, Inc. "We are confident in the safety and efficacy of dabigatran when used as directed to reduce the
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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