Business Wire

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

Del

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

Further Media Channels
www.facebook.com/boehringeringelheim
www.twitter.com/Boehringer

Contact information

Boehringer Ingelheim GmbH
Corporate Communications
Media + PR
Friederike Middeke
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
E-mail:  press@boehringer-ingelheim.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

BCW Acquires Creative Powerhouse HZ, Significantly Expanding Expertise in Integrated Communications14.8.2018 14:26Pressemelding

BCW (Burson Cohn & Wolfe), a leading global communications agency and a WPP company, today announced it has acquired HZ, one of the largest independent, digitally driven, integrated creative agencies in the U.S. Headquartered in Rockville, Maryland with offices in Baltimore, Los Angeles, New York and Washington, D.C., the acquisition will add the capability of HZ’s nearly 200 creative and digital professionals to BCW’s deep expertise in integrated communications across all industry sectors. HZ’s wide-ranging offerings include a full spectrum of multichannel digital design and development, mobile activation, social media, brand and identity creation, content, film and video production, search marketing (SEO/SEM), data and analytics as well as integrated media solutions. HZ’s broad client base spans the consumer, hospitality, food & beverage, education, B2B, real estate, sports & entertainment, healthcare and technology industries and counts Hilton Worldwide, Salesforce.org and Tishman S

Andersen Global Initiates Expansion in Mozambique14.8.2018 13:30Pressemelding

Andersen Global continues expansion in Africa with Isalcio Mahanjane e Associados, a law firm headquartered in Maputo, Mozambique. The collaboration with Isalcio Mahanjane e Associados signifies Andersen’s growth in the African region, as Mozambique provides strategic coverage in Southeast Africa and is the sixth country to collaborate or join in Africa in the past 14 months. Led by Managing Partner Isalcio Mahanjane, the firm includes 10 professionals and specializes in providing quality services in all branches of law for corporations and individuals. These services include commercial and corporate law, banking and financial law, labor law, real estate management, oil and gas, mines, and law and administrative litigation. “Mozambique will be a key point of connectivity with our practice in Portugal as we continue to focus on best-in-class solutions in Africa,” commented Global Chairman and Andersen Tax LLC CEO, Mark Vorsatz. “Isalcio and his team are passionate about their practice a

CTS Engines Inducts First PW2000 Engine14.8.2018 12:00Pressemelding

CTS Engines, the global leader for mature engine maintenance within the Aerospace & Defense industry, announced today that it had inducted the first PW2000 engine into its engine overhaul facility in Ft. Lauderdale, FL. Along with the CF6-80C2, CF6-80A, and CF6-50C2, the PW2000 represents the fourth engine model type serviced by CTS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180814005021/en/ PW2000 Engine. (Photo: Business Wire) “The profile of the PW2000 engine—which will continue to operate on B757s in cargo configuration and on C-17 Globemaster military transport aircraft for years to come—is an ideal fit for the CTS product line,” said Vesa Paukkeri, CTS’s President and Chief Operating Officer. “CTS is the go-to independent jet engine MRO for sunset engines operating in cargo and military transport configurations. We look forward to servicing this engine through the remainder of its time on wing over the next 30+ ye

Gyeonggi Province of Korea Launches Beyond the Dream Global VLOG Contest14.8.2018 12:00Pressemelding

Gyeonggi Provincial Government and Gyeonggi Tourism Organization (GTO) are hosting an international video contest called “Beyond the Dream VLOG Contest 2018.” Video submissions will be accepted until August 26, 2018 (Korean Standard Time). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180814005240/en/ Gyeonggi Provincial Government and Gyeonggi Tourism Organization (GTO) are hosting an international video contest called "Beyond the Dream VLOG Contest 2018." Video submissions will be accepted until August 26, 2018 (Korean Standard Time). The goal of the "Beyond the Dream VLOG Contest 2018" is to raise global awareness of Gyeonggi Province as an attractive travel destination and to select a Gyeonggi-do tourism ambassador who will show the world the charms of the province. Four final-winning teams will win a 10 day trip to Gyeonggi Province. USD 10,000 travel expenses for airline tickets and other travel expenses will be provi

BOC Group has just released ADONIS:CE – A Milestone in Free Cloud BPM Tools!14.8.2018 11:00Pressemelding

BOC Group announces the release of brand new ADONIS:Community Edition, now available in the cloud for free. Today, BOC Group launched the next in line descendent of its worldwide-known free Business Process Management tool, ADONIS:CE. This launch is more than just a product update: it marks the ADONIS:Community Edition's shift to the battle-tested web-platform and its transition to the cloud as SaaS. Based on the latest version of BPM suite's commercial edition ADONIS NP 5.5, ADONIS:CE makes a grand entrance with its fresh design, state-of-the-art functionality and exceptional user experience. Tobias Rausch, ADONIS product manager elaborates: “We believe in spreading BPM to all regions, as well as teams and companies of all sizes, by providing a free-of-charge tool that helps businesses improve their process game. That is why we have designed a freely available BPM tool with such an outstanding and rich feature-set.” In addition to the capabilities mentioned above, ADONIS:CE comes with

Interxion Announces Direct Connectivity to Google Cloud Platform across Its European Footprint14.8.2018 08:00Pressemelding

INTERXION HOLDING NV (NYSE: INXN), a leading provider of carrier and cloud-neutral colocation data centre services in Europe, today announced that dedicated access to Google Cloud Platform (GCP) is now available across its European footprint through Cloud Connect, Interxion’s multi-cloud interconnection platform. With Google Cloud deploying its Cloud Interconnect points of presence (PoPs) in Interxion’s Paris, Marseille, Frankfurt and Stockholm data centres, customers can now directly connect to Google Cloud Platform from these locations. Moreover, because Interxion is a partner of Google Cloud’s newly launched Partner Interconnect service, customers can also connect from any of Interxion’s data centres across Europe via Cloud Connect. Customers using this service benefit from fully redundant, instant access to GCP from multiple metropolitan areas, ensuring a 99.99% availability SLA without the complexity and costs of having to build a networking solution themselves. “We are seeing str