|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)
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Feb. 13, 2016 07:00 PM EST Reads: 416
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Feb. 13, 2016 04:45 PM EST Reads: 206
CIOs and those charged with running IT Operations are challenged to deliver secure, audited, and reliable compute environments for the applications and data for the business. Behind the scenes these tasks are often accomplished by following onerous time-consuming processes and often the management of these environments and processes will be outsourced to multiple IT service providers. In addition, the division of work is often siloed into traditional "towers" that are not well integrated for cro...
Feb. 13, 2016 04:00 PM EST Reads: 512
SYS-CON Events announced today that FalconStor Software® Inc., a 15-year innovator of software-defined storage solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. FalconStor Software®, Inc. (NASDAQ: FALC) is a leading software-defined storage company offering a converged, hardware-agnostic, software-defined storage and data services platform. Its flagship solution FreeStor®, utilizes a horizonta...
Feb. 13, 2016 02:30 PM EST
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 13, 2016 02:00 PM EST Reads: 258
SYS-CON Events announced today that Avere Systems, a leading provider of enterprise storage for the hybrid cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Avere delivers a more modern architectural approach to storage that doesn’t require the overprovisioning of storage capacity to achieve performance, overspending on expensive storage media for inactive data or the overbuilding of data centers ...
Feb. 13, 2016 01:30 PM EST Reads: 145
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 13, 2016 01:30 PM EST Reads: 285
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 13, 2016 12:45 PM EST Reads: 472
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 13, 2016 12:00 PM EST Reads: 451
The Quantified Economy represents the total global addressable market (TAM) for IoT that, according to a recent IDC report, will grow to an unprecedented $1.3 trillion by 2019. With this the third wave of the Internet-global proliferation of connected devices, appliances and sensors is poised to take off in 2016. In his session at @ThingsExpo, David McLauchlan, CEO and co-founder of Buddy Platform, will discuss how the ability to access and analyze the massive volume of streaming data from mil...
Feb. 13, 2016 12:00 PM EST
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
Feb. 13, 2016 12:00 PM EST
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
Feb. 13, 2016 12:00 PM EST Reads: 474
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 13, 2016 11:45 AM EST Reads: 313
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 13, 2016 11:45 AM EST Reads: 278
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
Feb. 13, 2016 11:45 AM EST