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
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.”
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
Boehringer Ingelheim GmbH
Media + PR
Phone: +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Westinghouse Accident Tolerant Fuel Development Moves Forward with Cooperation Agreement with ENUSA25.5.2018 09:00 | Tiedote
Westinghouse Electric Company today announced that it will collaborate in the development of its EnCore® Fuel, the revolutionary accident-tolerant fuel (ATF) design, with ENUSA Industrias Avanzadas (ENUSA) through a Frame Cooperation Agreement (FCA). “This agreement serves to strengthen the technical and commercial relations between ENUSA and Westinghouse as we work to develop leading nuclear fuel technology,” said Torbjörn Norén, European Fuel Group and EMEA Fuel Delivery Director at Westinghouse. “Westinghouse’s work with ENUSA in the Spanish and European Fuel Group markets will help to facilitate agreements with customers to launch EnCore Fuel demonstration programs in their plants.” Under the terms of the agreement, the newly signed FCA establishes the framework that will regulate the different Joint Development Programs (JDPs) to be launched between both companies. The first JDP will evaluate the application of the segmented rod concept and develop models of ATF / EnCore fuel beha
BRIC HOLDING Offers Aimedis – ICO: Germany’s Leading eHealth Platform Goes Public25.5.2018 09:00 | Tiedote
Since Wednesday, May 16, investors finally have a chance to claim their share of a unique success story, the international market roll-out of Aimedis, by purchasing AIM tokens: AIM tokens are now available with a 20% presale bonus PLUS a 5% early bird-premium only at the Czech investment house BRIC INVEST https://www.bric-holding.com/home_en.html! Aimedis aims to shape the future of healthcare by providing an advanced and fully operational platform, secured by blockchain and supported by AI, that enables patients to take control, secure the exchange of their medical data, access the best healthcare providers, get advice, prescriptions, personal health upgrades and to become part of the health revolution. And we are not talking about the future: The revolutionary Aimedis platform is already deployed as a live working system and is already in use in major hospital groups in Germany! By issuing 300 million AIM tokens at a nominal value of 0,12 USD each, the Aimedis consortium will raise c
Alps Electric to Acquire Greina Technologies, Inc. as Part of Sensor Business Strengthening25.5.2018 05:33 | Tiedote
Alps Electric Co., Ltd. (TOKYO: 6770; President: Toshihiro Kuriyama; Head Office: Tokyo) today announces that on May 14, 2018 the company signed a share purchase agreement with Greina Technologies, Inc. (Salt Lake City, Utah, U.S.A.; President/CTO: Daniel J. Lee) whereby Alps Electric will acquire Greina Technologies, making it a wholly owned subsidiary. Alps Electric signed a share purchase agreement with Greina Technologies on May 14, 2018. Through the agreement, Alps Electric aims to add even greater value to its sensing solutions for the automotive market, as well as the consumer electronics and mobile market, by combining high-accuracy positioning technology based on original algorithms developed by Greina Technologies with Alps Electric’s compact, high-performance wireless communication module technology. An engineering firm specializing in positioning systems, Greina Technologies was established in Salt Lake City, Utah, in September 2012. Engaging in such activities as design an
IFF Strengthens Innovation Platform as Partner in Amkiri’s Visual Fragrance™ Technology24.5.2018 23:15 | Tiedote
Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, announced its partnership in Amkiri’s Visual Fragrance Technology -- a new ‘ink’ that can be drawn on the skin that also delivers a long-lasting fragrance, thus connecting the senses of sight and smell. The innovative product’s launch was announced on March 22, 2018 by Amkiri, an Israeli-based start-up that was founded in 2014. “This is a significant innovation in the fragrance category, merging strong and deeply personal visuals with the resonance and emotion of fragrance,” said IFF Chairman and CEO Andreas Fibig. “The Visual Fragrance technology creates a new platform from which IFF can showcase our capabilities, including naturals, molecules, and cosmetic actives. The potential for innovative applications are nearly endless and our teams are truly inspired by the possibilities.” Amkiri’s patented Visual Fragrance is applied to th
Hisense's Zhou Houjian and Huawei's Kevin Ho to Keynote CES Asia; Focus on Mobility, 5G and Connectivity24.5.2018 18:00 | Tiedote
The Consumer Technology AssociationTM (CTA) today announced that Hisense Chairman Zhou Houjian and Huawei’s president of Handset Product Line Kevin Ho will deliver separate keynote addresses at the upcoming CES AsiaTM 2018. As CES Asia drives the expansion of technology into new areas like artificial intelligence, vehicle technology, AR, VR and more, Chairman Zhou and Mr. Ho will discuss the future of innovation at their respective companies through connectivity and mobility during Asia’s premier tech event. “Hisense and Huawei have become major global brands by challenging the status quo and creating innovative product solutions that engage, entertain and connect consumers around the world,” said Gary Shapiro, president and CEO, CTA. “We are thrilled to welcome Chairman Zhou and Mr. Ho to the CES Asia keynote stage and are eager to learn from these experts who are leading the charge to harness the potential of 5G through various implementation strategies and connection opportunities.”
Maximum Cryptocurrencies Available for EU Traders in Libertex24.5.2018 17:29 | Tiedote
Libertex trading platform, operated by Indication Investments Ltd, announces that starting from May 23rd 2018, European traders can perform operations with 34 new cryptocurrency CFD instruments. This means that Libertex became one of the leading applications and trading platforms for EU traders in terms of amount of cryptocurrencies available. Andrew Nikolaev, Libertex Executive director highlighted: “Cryptocurrencies are one of the main trends in financial industry for the past couple of years. The demand for these assets grows significantly. We are happy to satisfy the demand of European traders for new innovative crypto-instruments launching them in our cutting edge Libertex platform”. Launch of cryptocurrency pairs in Libertex for EU traders follows Circular from Cyprus financial regulator - CySec issued on May 15th 2018, that introduces new rules for governing derivatives on virtual currencies. According to this Circular, CFDs on virtual currencies are considered as financial inst
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme