|By PR Newswire||
|April 2, 2014 07:01 AM EDT||
MUNICH, Germany, April 2, 2014 /PRNewswire/ --
For European Media Only, Not for UK Media
Atrial fibrillation (AF) is the most common heart rhythm disorder resulting in a five-fold increased risk of stroke compared with the general population
Daiichi Sankyo today announced its commitment to extend the PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF). The extension of the registry will include a specific focus on the use of Novel Oral Anticoagulant (NOAC) therapy including prescribing patterns, providing new insight into the long-term management of patients with atrial fibrillation (AF).
The PREFER in AF Registry was initially conducted in seven European countries with over 7,000 patients to gain detailed insight into the characteristics and management of AF, with a focus on the prevention of thromboembolic events, and in particular, stroke. Baseline results released at EHRA EUROPACE in June 2013 illustrated recent changes in the management of AF and some uptake of NOACs following their inclusion in the updated ESC guidelines. This extension to the registry will collect additional up to date real life data from approximately 5,000 patients across more than 320 centres in nine European countries, including the addition of two new countries; Belgium and The Netherlands.
"Despite the introduction of a number of new oral anticoagulants there remains a lack of data on current management of AF patients in clinical practice settings. The PREFER in AF registry enables us to observe and understand different anticoagulation treatment patterns, giving us a valuable and much needed insight into the long-term management of patients with AF and specifically the use of NOACs," explains Professor Paulus Kirchhof, Chair in Cardiovascular Medicine, University of Birmingham and Chair of the PREFER in AF Steering Committee. "It is critical that patients with AF who are at risk of experiencing stroke and thromboembolism maintain effective anticoagulation - and this extended registry will provide vital data to support clinicians with their prescribing decisions."
The extended registry places a special focus on the use of NOACs and corresponding treatment patterns; including the reasons for switching AF patients to NOACs from vitamin K antagonists (VKAs). VKAs, such as warfarin, are the current standard of care but require frequent monitoring and dose adaptation to keep patients within therapeutic range. For patients with AF who are at risk of experiencing stroke and thromboembolism, it is critical to maintain effective anticoagulation.
AF is the most common type of heart rhythm disorder, and a major cause of morbidity and mortality across Europe. Patients with AF have a five-fold increased risk of stroke compared with the general population, and stroke in those suffering with AF is more severe, more likely to cause disability, and nearly twice as likely to be fatal than in those without AF. AF also places a considerable burden on European health systems, with inpatient care and interventional procedures accounting for the majority of costs.
"As part of Daiichi Sankyo's commitment to the advancement of cardiovascular medicine, multi-national registries are now underway in both AF and VTE," comments Dr. Jan van Ruymbeke, CEO Daiichi Sankyo Europe. "Through these we aim to provide clinicians with data that can improve future management of AF and VTE and support them in delivering the best outcomes for patients while effectively managing resources."
Further results from the PREFER in AF initial registry period are due to be presented later this year.
To address the common and significant limitations of existing therapies, Daiichi Sankyo is currently investigating a novel oral anticoagulant. Edoxaban, the once-daily factor Xa inhibitor, is currently being evaluated for the prevention of stroke and systemic embolic events (SEE) in patients with atrial fibrillation (AF), as well as for preventing recurrent VTE complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE). The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation).,
Notes to editors:
About PREFER in AF
The initial PREFER in AF registry enrolled 7,243 AF patients across 461 centres in Austria, France, Germany, Italy, Spain, Switzerland and the UK, to provide information on the clinical outcomes of patients on different treatment regimens, as well as other important considerations such as management of AF patients, adherence to therapy, quality of life and treatment satisfaction.
The Prolongation of PREFER in AF Registry is designed to both prolong the currently ongoing PREFER in AF registry to improve clinical understanding of AF management, as well as to extend this registry to two additional countries (Belgium and the Netherlands) to further improve clinical understanding of NOAC management over a 24 month period. Enrolment of new patients will take place in all regions. Data will be collected from 5,000 patients across 325 centres in nine European countries (Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland and the United Kingdom).
About PREFER in VTE
Daiichi Sankyo has also recently analysed the first baseline data of the PREFER in VTE registry, covering information from 1,783 VTE patients. PREFER in VTE is the first registry of its kind to collate comprehensive data on the disease management in patients with VTE with key insight into patient satisfaction and quality of life. First results from the first study period of PREFER in VTE registry are due to be presented later this year.
Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation). The results from these trials form the basis of the MAA for edoxaban for the prevention of stroke and SEE in patients with NVAF, as well as for the treatment of DVT or PE and prevention of recurrence of symptomatic VTE.
Edoxaban is currently approved only in Japan, since April 2011, for the prevention of VTE after major orthopaedic surgery, and was launched in July 2011 under the brand name LIXIANA®. Elsewhere, including Europe and the U.S., edoxaban is currently in phase 3 clinical development and has not been approved in any indication.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: http://www.daiichisankyo.com.
About Daiichi Sankyo Europe
Daiichi Sankyo's European base is located in Munich and has affiliates in 12 European countries in addition to a global manufacturing site located in Pfaffenhofen, Germany. For more information, please visit: http://www.daiichi-sankyo.eu.
This press release contains forward-looking statements and information about future developments in the sector,and the legal and business conditions of Daiichi Sankyo Europe GmbH. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. Daiichi Sankyo Europe GmbH assumes no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.
- Iqbal, M. B., Taneja, A. K., Lip, G. Y. H. & Flather, M. Recent developments in atrial fibrillation. BMJ. 2005;330:238-43.
- Camm, A. et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). European Heart Journal. 2010;31:2369-429.
- Kirchhof P, et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF). Europace 2013. doi: 10.1093/europace/eut263.
- Jones, M. et al. Evaluation of the pattern of treatment, level of anticoagulation control, and outcome of treatment with warfarin in patients with non-valvar atrial fibrillation: a record linkage study in a large British population. Heart. 2005:91:472-7.
- National Institute for Health and Care Excellence. Atrial fibrillation: the management of atrial fibrillation. Clinical guideline: Methods, evidence and recommendations. January 2014. Available at: http://www.nice.org.uk/nicemedia/live/13590/66267/66267.pdf [Last accessed: March 2014]
- Lin, H., Wolf, P. A., Kelly-Hayes, M. & Benjamin, E. J. Stroke Severity in Atrial Fibrillation. Stroke. 1996;27:1760-1764.
- Ringborg A, Nieuwlaat R, Lindgren P, et al. Costs of atrial fibrillation in five European countries: results from the Euro Heart Survey on atrial fibrillation. Europace. 2008;10(4):403-11.
- Büller, H et al. Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism. N Engl J Med 2013;369:1406-1415.
- Giugliano, R et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2013;369:2093-2104.
- Ogata, K et al. Clinical Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers. J Clin Pharmacol 2010;50:743-753.
For more information, please contact:
Daiichi Sankyo Europe GmbH
Tel: +49-(89)-7808728 (Office)
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. In the eyes of many, containers are at the brink of becoming a pervasive technology in enterprise IT to accelerate application delivery. In this presentation, you'll learn about the: The transformation of IT to a DevOps, microservices, and container-based architecture What are containers and how DevOps practices can operate in a container-based environment A demonstration of how Docke...
Oct. 28, 2016 05:45 PM EDT Reads: 1,721
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Oct. 28, 2016 05:30 PM EDT Reads: 3,319
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
Oct. 28, 2016 05:30 PM EDT Reads: 285
President Obama recently announced the launch of a new national awareness campaign to "encourage more Americans to move beyond passwords – adding an extra layer of security like a fingerprint or codes sent to your cellphone." The shift from single passwords to multi-factor authentication couldn’t be timelier or more strategic. This session will focus on why passwords alone are no longer effective, and why the time to act is now. In his session at 19th Cloud Expo, Chris Webber, security strateg...
Oct. 28, 2016 04:45 PM EDT Reads: 298
November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Penta Security is a leading vendor for data security solutions, including its encryption solution, D’Amo. By using FPE technology, D’Amo allows for the implementation of encryption technology to sensitive data fields without modification to schema in the database environment. With businesses having their data become increasingly more complicated in their mission-critical applications (such as ERP, CRM, HRM), continued ...
Oct. 28, 2016 04:30 PM EDT Reads: 1,227
In the 21st century, security on the Internet has become one of the most important issues. We hear more and more about cyber-attacks on the websites of large corporations, banks and even small businesses. When online we’re concerned not only for our own safety but also our privacy. We have to know that hackers usually start their preparation by investigating the private information of admins – the habits, interests, visited websites and so on. On the other hand, our own security is in danger bec...
Oct. 28, 2016 04:30 PM EDT Reads: 769
Two weeks ago (November 3-5), I attended the Cloud Expo Silicon Valley as a speaker, where I presented on the security and privacy due diligence requirements for cloud solutions. Cloud security is a topical issue for every CIO, CISO, and technology buyer. Decision-makers are always looking for insights on how to mitigate the security risks of implementing and using cloud solutions. Based on the presentation topics covered at the conference, as well as the general discussions heard between sessi...
Oct. 28, 2016 04:30 PM EDT Reads: 5,253
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Oct. 28, 2016 04:00 PM EDT Reads: 3,876
SYS-CON Events announced today that Cloudbric, a leading website security provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Cloudbric is an elite full service website protection solution specifically designed for IT novices, entrepreneurs, and small and medium businesses. First launched in 2015, Cloudbric is based on the enterprise level Web Application Firewall by Penta Security Sys...
Oct. 28, 2016 03:15 PM EDT Reads: 1,382
SYS-CON Events announced today that Impiger Technologies will exhibit in Booth #109 at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Impiger Technologies is a world-class, enterprise software product engineering company specializing in Mobile Application Development, Cloud Applications, Microsoft Technology Solutions, Web Technology and Telecom Services. Impiger Technologies helps enterprises improve busi...
Oct. 28, 2016 03:00 PM EDT Reads: 432
Virgil consists of an open-source encryption library, which implements Cryptographic Message Syntax (CMS) and Elliptic Curve Integrated Encryption Scheme (ECIES) (including RSA schema), a Key Management API, and a cloud-based Key Management Service (Virgil Keys). The Virgil Keys Service consists of a public key service and a private key escrow service.
Oct. 28, 2016 02:30 PM EDT Reads: 1,250
SYS-CON Events announced today that Cemware will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Use MATLAB functions by just visiting website mathfreeon.com. MATLAB compatible, freely usable, online platform services. As of October 2016, 80,000 users from 180 countries are enjoying our platform service.
Oct. 28, 2016 02:15 PM EDT Reads: 1,020
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Oct. 28, 2016 02:15 PM EDT Reads: 4,025
Digitization is driving a fundamental change in society that is transforming the way businesses work with their customers, their supply chains and their people. Digital transformation leverages DevOps best practices, such as Agile Parallel Development, Continuous Delivery and Agile Operations to capitalize on opportunities and create competitive differentiation in the application economy. However, information security has been notably absent from the DevOps movement. Speed doesn’t have to negat...
Oct. 28, 2016 02:00 PM EDT Reads: 2,955
SYS-CON Events announced today that eCube Systems, the leading provider of modern development tools and best practices for Continuous Integration on OpenVMS, will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. eCube Systems offers a family of middleware products and development tools that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Oct. 28, 2016 02:00 PM EDT Reads: 4,703