Business Wire

Real-World Analysis of more than 44,000 Patients Reinforces Safety and Effectiveness of Pradaxa® in Routine Clinical Care

Del

Brigham and Women’s Hospital in Boston, U.S., and Boehringer Ingelheim announce the results of a new interim analysis from a long-term study evaluating the safety and effectiveness of Pradaxa® (dabigatran etexilate) relative to warfarin in routine clinical practice.1 These data, from a pooled analysis of two large U.S. commercial health insurance databases, showed that patients with non-valvular atrial fibrillation (AF) treated with Pradaxa® had fewer strokes and fewer major bleeding events compared to AF patients treated with warfarin.1 The findings were presented at the American Heart Association (AHA) Scientific Sessions 2015 in Orlando.

“Beyond clinical trials, there is a wealth of available health insurance data that provides an excellent opportunity to grow our knowledge of oral anticoagulant use and outcomes for patients,” said lead investigator John Seeger, PharmD, DrPH, Department of Medicine, Brigham and Women’s Hospital, a teaching-affiliate of Harvard Medical School. “These real-world data further define the safety and effectiveness of dabigatran for patients and its use in routine care, and are consistent with the results of the pivotal RE-LY® clinical trial.”

The primary study outcomes were stroke and major bleeding rates during Pradaxa® and warfarin treatment, based on data collected over 32 months from 44,672 AF patients (22,336 propensity score matched Pradaxa® and warfarin treatment initiators) in two insurance databases — Truven MarketScan (18,276 patients per group) and Optum Clinformatics (4,060 patients per group). Researchers identified 65 strokes for Pradaxa®-treated patients (0.73 incidence rate per 100 patient years) and 78 strokes for warfarin-treated patients (1.08 incidence rate per 100 patient years), representing a 28% reduction in stroke risk for Pradaxa® compared to warfarin (HR 0.72; 95% CI 0.52 – 1.00). In addition, researchers reported 395 major bleeding events for Pradaxa®-treated patients (4.47 incidence rate per 100 patient years), compared to 459 events for warfarin-treated patients (6.42 incidence rate per 100 patient years), representing a 26% reduction in the risk of major bleeding events with Pradaxa® compared to warfarin (HR 0.74; 95% CI 0.64 – 0.84). There were 238 major gastrointestinal bleeding events for Pradaxa®-treated patients (2.69 incidence rate per 100 patient years) and 213 for warfarin treated patients ((2.97 incidence rate per 100 patient years); HR 0.95; 95% CI 0.79 - 1.14).1

“With this long-term study programme, in collaboration with Brigham and Women’s Hospital, we are seeking to expand awareness and understanding of real-world experiences with non-vitamin K antagonist oral anticoagulants (NOACs) and the impact on reducing stroke risk, which remains a major public health concern,” said Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “These data add to the robust world of evidence supporting the real-world value of Pradaxa®, the only NOAC with both proven superiority to warfarin in reducing stroke risk in AF patients and a specific reversal agent.”

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

~ENDS~

Please click on the link below for ‘Notes to Editors’ and References’:

https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/10_november_2015pradaxa2.html

Contact information

Boehringer Ingelheim GmbH
Corporate Communications

Media + PR
Friederike Middeke, +49 6132 – 77 141575
Fax: +49 6132 – 77 6601
E-mail:  press@boehringer-ingelheim.com
Twitter:  http://twitter.com/Boehringer
or
More information
www.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

Equifax Integrates Entersekt’s Digital Security System22.2.2018 12:35Pressemelding

Entersekt, a leader in push-based authentication and mobile app security, today announced a technology partnership with global information solutions company Equifax Inc. (NYSE:EFX). Equifax has licensed Entersekt’s product Transakt to serve as an additional layer of security protecting the Equifax online and mobile services. Transakt empowers consumers to play an active role in safeguarding their digital identities and accounts. Whenever access to a digital identity or account is required, an authentication request is pushed to their phone or tablet in real time. They approve or block access by simply tapping Accept or Reject. It’s a highly intuitive, one-touch user experience engineered for a mobile-first world. Transakt’s ease of use belies its advanced set of security features. Covered by 56 patents in the United States and elsewhere, the digital-certificate–based technology uniquely identifies each registered mobile device; ensures its continued integrity as a factor of authenticat

ImmerVision to Showcase AI-Ready Vision Technology at MWC 201822.2.2018 12:00Pressemelding

ImmerVision, a technology company enabling intelligent vision in all the world’s devices, announced today that it is uniquely prepared to provide AI-ready, data-rich image processing to today’s most incisive device makers and manufacturers. Indeed, ImmerVision is already providing such hyper-intelligent image capture capabilities to some of the world’s top brands. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180222005513/en/ ImmerVision Enables AI-ready intelligent devices include Acer Holo360, Quanta Pi SOLO, and Tamaggo 360LiveCam (Graphic: Business Wire) Based in Montreal, Canada, ImmerVision develops wide-angle panomorph lenses and data-augmented imaging algorithms, enabling creative manufacturers to see more and smarter while creating professional and consumer devices. “In our quest to enable intelligent vision in every device, ImmerVision has taken a great leap forward,” says Alessandro Gasparini, Executive Vice Presi

Kite, a Gilead Company, and Sangamo Therapeutics Announce Collaboration to Develop Next-Generation Engineered Cell Therapies for the Treatment of Cancer22.2.2018 12:00Pressemelding

Kite, a Gilead Company (Nasdaq:GILD) and Sangamo Therapeutics, Inc. (Nasdaq:SGMO) today announced the companies have entered into a worldwide collaboration using Sangamo’s zinc finger nuclease (ZFN) technology platform for the development of next-generation ex vivo cell therapies in oncology. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180222005488/en/ Kite will use Sangamo’s ZFN technology to modify genes to develop next-generation cell therapies for autologous and allogeneic use in treating different cancers. Allogeneic cell therapies from healthy donor cells or from renewable stem cells would provide a potential treatment option that can be accessed directly within the oncology infusion center, thus reducing the time to infusion for patients. Under the terms of the agreement, Sangamo will receive an upfront payment of $150 million and is eligible to receive up to $3.01 billion in potential payments, aggregated across 10

CorFlow Presents Fundamental New Insights into the Coronary Microcirculation at ACC22.2.2018 09:10Pressemelding

CorFlow Therapeutics AG (www.corflow-therapeutics.ch) today announced that the company will present fundamental new insights into the coronary microcirculation during the annual meeting of the American College of Cardiology (ACC) in Orlando, FL, March 10-12, 2018. CorFlow has since its foundation in June 2016 worked to document that the Controlled Flow Infusion (CoFITM) technology is able to measure the coronary microvascular status and provide therapy to the compromised coronary microcirculation at the same time. Microvascular obstruction (MVO) affects more than half of the acute heart attack patients and is an independent predictor for complications including heart failure which constitutes a high cost burden for the world-wide health care system. To address this large unmet medical need in interventional cardiology, CorFlow has developed an in-vivo model which reproducibly creates MVO in an occlusion-reperfusion model with very low complication rates. Using this in-vivo model, the C

DocsCorp White Paper Encourages Businesses to Review their 2018 Data Protection Strategy – Protection through Technology22.2.2018 09:02Pressemelding

Tough new data protection laws are coming – are you prepared? Reviewing your data protection strategy in 2018, a new white paper published today by DocsCorp, challenges readers to assess their readiness to comply with rigorous upcoming data protection standards affecting businesses in Europe, the Americas and Australia. DocsCorp contends that organizations around the world will be affected by new data laws. The UK’s General Data Protection Regulation (GDPR) goes into force in May 2018. Australia’s new, sweeping National Data Breach (NDB) notification laws already require all businesses to report data breaches. In the United States, many individual states have passed their own data protection laws, and the US federal government has proposed the nationwide Data Security and Breach Notification Act, currently under congressional review. A main focus of GDPR is “Privacy by Design and Default,” which recommends preventative action before breaches occur rather than coping with damages and pe

GSMA Warns That Policymakers Must Act Now to Avoid Mobile Network “Gridlock” in Major Cities22.2.2018 09:00Pressemelding

The GSMA today published a new report that examines the ability of mobile networks to meet the exploding demand for mobile data in the world’s largest and densest cities. The GSMA/Boston Consulting Group report, “Delivering the Digital Revolution: Will Mobile Infrastructure Keep Up with Rising Demand?”, finds that networks in so-called “megacities” such as New York, Shanghai, Shenzhen and Tokyo will face a significant gap between mobile data traffic demand and available network capacity, with as much as 48 per cent of traffic demand going unserved in ultra-dense urban areas by 2025. The report highlights that regulatory reform will be critical in closing the projected supply-demand gap and unlocking the economic potential of next-generation mobile broadband. “The current global regulatory landscape has been successful in creating a competitive market that has made mobile connectivity accessible to more than five billion people around the world,” said John Giusti, Chief Regulatory Offic