|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)
While DevOps promises a better and tighter integration among an organization’s development and operation teams and transforms an application life cycle into a continual deployment, Chef and Azure together provides a speedy, cost-effective and highly scalable vehicle for realizing the business values of this transformation. In his session at @DevOpsSummit at 19th Cloud Expo, Yung Chou, a Technology Evangelist at Microsoft, will present a unique opportunity to witness how Chef and Azure work tog...
Sep. 29, 2016 04:45 AM EDT Reads: 1,793
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Sep. 29, 2016 04:30 AM EDT Reads: 4,672
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Sep. 29, 2016 04:00 AM EDT Reads: 1,805
The Transparent Cloud-computing Consortium (abbreviation: T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data processing High speed and high quality networks, and dramatic improvements in computer processing capabilities, have greatly changed the nature of applications and made the storing and processing of data on the network commonplace.
Sep. 29, 2016 04:00 AM EDT Reads: 1,207
We’ve been doing it for years, decades for some. How many websites have you created accounts on? Your bank, your credit card companies, social media sites, hotels and travel sites, online shopping sites, and that’s just the start. We do it often without even thinking about it, quickly entering our personal information, our data, in a plethora of systems. Sometimes we’re not even aware of the information we are providing. It could be very personal information (think of the security questions you ...
Sep. 29, 2016 03:45 AM EDT Reads: 4,818
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor 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. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Sep. 29, 2016 03:30 AM EDT Reads: 3,029
I'm a lonely sensor. I spend all day telling the world how I'm feeling, but none of the other sensors seem to care. I want to be connected. I want to build relationships with other sensors to be more useful for my human. I want my human to understand that when my friends next door are too hot for a while, I'll soon be flaming. And when all my friends go outside without me, I may be left behind. Don't just log my data; use the relationship graph. In his session at @ThingsExpo, Ryan Boyd, Engi...
Sep. 29, 2016 03:30 AM EDT Reads: 1,375
IoT offers a value of almost $4 trillion to the manufacturing industry through platforms that can improve margins, optimize operations & drive high performance work teams. By using IoT technologies as a foundation, manufacturing customers are integrating worker safety with manufacturing systems, driving deep collaboration and utilizing analytics to exponentially increased per-unit margins. However, as Benoit Lheureux, the VP for Research at Gartner points out, “IoT project implementers often ...
Sep. 29, 2016 03:15 AM EDT Reads: 3,575
SYS-CON Events announced today that Pulzze Systems 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. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Sep. 29, 2016 03:15 AM EDT Reads: 1,905
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Sep. 29, 2016 03:00 AM EDT Reads: 1,868
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
Sep. 29, 2016 02:45 AM EDT Reads: 1,718
As ridesharing competitors and enhanced services increase, notable changes are occurring in the transportation model. Despite the cost-effective means and flexibility of ridesharing, both drivers and users will need to be aware of the connected environment and how it will impact the ridesharing experience. In his session at @ThingsExpo, Timothy Evavold, Executive Director Automotive at Covisint, will discuss key challenges and solutions to powering a ride sharing and/or multimodal model in the a...
Sep. 29, 2016 02:30 AM EDT Reads: 520
Is your aging software platform suffering from technical debt while the market changes and demands new solutions at a faster clip? It’s a bold move, but you might consider walking away from your core platform and starting fresh. ReadyTalk did exactly that. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, will discuss why and how ReadyTalk diverted from healthy revenue and over a decade of audio conferencing product development to start an innovati...
Sep. 29, 2016 02:30 AM EDT Reads: 2,174
WebRTC adoption has generated a wave of creative uses of communications and collaboration through websites, sales apps, customer care and business applications. As WebRTC has become more mainstream it has evolved to use cases beyond the original peer-to-peer case, which has led to a repeating requirement for interoperability with existing infrastructures. In his session at @ThingsExpo, Graham Holt, Executive Vice President of Daitan Group, will cover implementation examples that have enabled ea...
Sep. 29, 2016 02:00 AM EDT Reads: 1,592
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
Sep. 29, 2016 01:45 AM EDT Reads: 2,057