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News breaking: 2017-11-14

New RE-VERSE AD™ analyses provide additional insights on impact of Praxbind® (idarucizumab) in Pradaxa® (dabigatran etexilate) patients with gastrointestinal bleeding or needing emergency surgery

INGELHEIM, Germany–(BUSINESS WIRE)– Boehringer Ingelheim announced results from two sub-analyses of the phase III RE-VERSE AD™ study.1,2 The sub-analyses evaluated the safety and efficacy of idarucizumab (marketed as Praxbind®) in reversing the anticoagulant effect of dabigatran etexilate (marketed as Pradaxa®) in patients in diverse emergency situations. These include those with acute bleeding or requiring an urgent surgery or procedure, such as an orthopedic, vascular or abdominal procedure. The analyses were presented at the American Heart Association (AHA) Scientific Sessions 2017 in Anaheim, California, USA. They provide further insights on the use of idarucizumab in patients with gastrointestinal (GI) bleeding and in those with a need for urgent surgery or intervention.

“The RE-VERSE AD study has demonstrated that idarucizumab can reverse the anticoagulant effect of dabigatran within minutes, allowing physicians to quickly initiate emergency interventions for patients who need urgent surgery or are experiencing uncontrollable bleeding,” said Charles Pollack, M.D., lead investigator of RE-VERSE AD, Professor of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, USA. “These new analyses further reinforce the potential for idarucizumab to enhance care for people living with atrial fibrillation.”

One of the sub-analyses focused on patients with GI bleeding,2 the most common type of bleeding event among patients who were enrolled in the study due to acute bleeding. Of the 137 patients enrolled with a GI bleed, complete reversal of the anticoagulant effect of dabigatran was observed in more than 95 percent of patients. The median time to cessation of bleeding post-idarucizumab administration was less than three hours when the location of the GI bleed was known and 6.4 hours when the location was unknown.

Mortality and thromboembolic event rates for patients with a GI bleed were consistent with the overall findings of RE-VERSE AD™. In the sub-analysis, as presented in the abstracts, at 90 days, there were low thromboembolic event rates of 5.1 percent in patients with a GI bleed, compared to 6.3 percent in non-GI bleed patients. Mortality in the first five days following administration was 6 percent in patients with a GI bleed, compared to 9 percent in non-GI bleed patients. At 90 days, mortality rates were 16 percent and 23 percent, respectively.2

Also presented at AHA were updated results assessing periprocedural bleeding in patients requiring an urgent procedure, such as an emergency surgery.1 Idarucizumab rapidly and completely reversed the anticoagulant effect of dabigatran in approximately 98 percent of patients based on diluted thrombin time (dTT). The median time between administration of idarucizumab and start of surgery was 1.7 hours for patients requiring abdominal procedures, 1.9 hours for orthopaedic procedures, 1.4 hours for vascular procedures, 1.3 hours for drainage procedures and 1.2 hours for catheter procedures. Among these patients, periprocedural bleeding was assessed as normal (if anticoagulation were absent) in more than 92 percent of patients, across all surgery types. Among patients needing emergency surgery, none were assessed as experiencing periprocedural bleeding that was severely abnormal (severe refractory hemorrhage). RE-VERSE AD™ is the only study to investigate anticoagulation reversal among patients requiring surgery.

“The RE-VERSE AD sub-analyses presented at the AHA Scientific Sessions provide insights in two highly relevant areas for patients and physicians,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Accidents can happen in life, also to patients taking an anticoagulant. Knowing that a fast-acting reversal agent is available is very reassuring to patients and their treating physicians. That is why we continue our efforts to expand the global availability of idarucizumab, the reversal agent for dabigatran.”

~ENDS~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/RE-VERSE-AD-sub-analyses-data-presented-at-AHA-2017

For more information, please visit: www.boehringer-ingelheim.com

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