SYS-CON MEDIA Authors: Yeshim Deniz, Elizabeth White, Sean Houghton, Glenn Rossman, Ignacio M. Llorente

News Feed Item

Daiichi Sankyo Initiates Phase 3 ENSURE-AF Study, Investigating Once-Daily Edoxaban in Patients with Atrial Fibrillation Undergoing Cardioversion

-- First patient enrolled in largest planned phase 3 study evaluating a novel oral anticoagulant in non-valvular atrial fibrillation patients undergoing electrical cardioversion

PARSIPPANY, New Jersey, March 31, 2014 /PRNewswire/ -- Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has started enrolling patients into the ENSURE-AF multinational phase 3 study, which will evaluate the efficacy and safety of its investigational oral, once-daily direct factor Xa-inhibitor edoxaban compared to enoxaparin/warfarin for the prevention of stroke and other blood clot complications in patients with non-valvular atrial fibrillation (NVAF) undergoing electrical cardioversion (low-energy shocks to trigger normal heart rhythm).1,2 More than 2,200 patients are expected to be enrolled in ENSURE-AF at approximately 250 clinical sites across North America and Europe.1

"Due to the risk of thromboembolism, clinical guidelines recommend anticoagulation before and after cardioversion in patients with atrial fibrillation," said Andreas Goette, MD, Chief Physician, St. Vincenz-Hospital Paderborn, Germany, Department of Cardiology and Intensive Care Medicine and member of the European Heart Rhythm Association's International Affairs Committee with responsibility for Japan.3,4  "This trial will provide us with insights on whether edoxaban can be a viable treatment option for non-valvular atrial fibrillation patients undergoing cardioversion."1

"This is a very exciting study as this will be the largest planned clinical trial to evaluate a novel oral anticoagulant with the current standard of care in patients undergoing cardioversion," said Gregory YH Lip, Professor of Cardiovascular Medicine, University of Birmingham, UK. "The novel oral anticoagulants offer the possibility of efficacy, safety and convenience for the peri-cardioversion management of patients with atrial fibrillation."

About ENSURE-AF

ENSURE-AF is a Prospective, Randomized, Open-Label, Blinded Endpont evaluation (PROBE), parallel group study, evaluating the efficacy and safety of once-daily edoxaban for the prevention of stroke, systemic embolic event, myocardial infarction and cardiovascular mortality versus enoxaparin/warfarin in patients with NVAF undergoing electrical cardioversion. More than 2,200 NVAF patients undergoing electrical cardioversion are expected to be enrolled at approximately 250 clinical sites across North America and Europe. Patients will be randomized to receive edoxaban 60 mg (or a patient specific dose of edoxaban 30 mg for patients with renal impairment or low body weight or p-glycoprotein inhibitor use) or enoxaparin/warfarin for 28-49 days.1

For more information please visit: http://clinicaltrials.gov/show/NCT02072434.

About Atrial Fibrillation and Cardioversion

Atrial fibrillation (AF) is a condition in which the heartbeat is rapid and irregular, and can potentially lead to a stroke. AF is a common condition, affecting approximately 2.3-3.4% of people in developed nations.5 Stroke is the second most common cause of death worldwide, responsible for approximately 6.2 million deaths each year.6 Compared to those without AF, people with the arrhythmia have a 3-5 times higher risk of stroke.5 Strokes due to AF are nearly twice as likely to be fatal than strokes in patients without AF at 30 days7 and have poorer prognosis than non-AF related strokes, with a 50% increased risk of remaining disabled at three months.8 Cardioversion is a procedure that can restore a fast or irregular heartbeat to a normal rhythm, but is associated with a risk of thromboembolic events, including stroke, in patients who do not receive anticoagulation therapy.2,9

About Edoxaban

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.10 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), which included nearly 30,000 patients combined. The results from these trials form the basis of regulatory filings for edoxaban for symptomatic venous thromboembolism (VTE) in patients with deep vein thrombosis and/or pulmonary embolism, and for the prevention of stroke in NVAF, respectively.11,12 Edoxaban is currently under regulatory review in Japan, the U.S. and EU for these indications.

Edoxaban is currently approved only in Japan, since April 2011, for the prevention of VTE after major orthopedic surgery, and was launched in July 2011 under the brand name Lixiana®. Elsewhere, including Europe and the U.S., edoxaban has not been approved in any indication.13

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: www.daiichisankyo.com.

Contact

Global Media

US Media

Michaela Paudler-Debus, PhD

Alyssa Dargento

[email protected]

[email protected]

+49 89 7808 685 (office)

+1 973 944 2913 (office)

+49 176 1178 0966 (mobile)

+1 973 727 1604 (mobile)



EU Media


Daria Munsel


[email protected]


+49 89 7808728 (office)


+49 176 11780826 (mobile)

Forward-looking statements

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO, Co., Ltd. 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, Co., Ltd. assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References

  1. Goette, A. Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Atrial Fibrillation (ENSURE IN AF). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000-2014. Available from http://clinicaltrials.gov/show/NCT02072434. NLM Identifier: NCT02072434.
  2. National Heart, Lung, and Blood Institute. What is Cardioversion. 2012. Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/crv/. [Last accessed: March 2014].
  3. American College of Cardiology Foundation and American Heart Association. ACCF/AHA pocket guideline: management of patients with atrial fibrillation. 2011. Available at: http://www.cardiosource.org/~/media/Files/Science%20and%20Quality/Guidelines/Pocket%20Guides/AFIB_PocketGuide.ashx. [Last accessed: March 2014].
  4. Camm, J et al. Guidelines for the management of atrial fibrillation. Eur Heart J 2010;31:2369-2429.
  5. Ball, J et al. Atrial fibrillation: Profile and burden of an evolving epidemic in the 21st century. Int J Card 2013; 167:1807-1824.
  6. World Health Organization. The top 10 causes of death. July 2013. Available at: who.int/mediacentre/factsheets/fs310/en/. [Last accessed: March 2014].
  7. Lin H et al. Stroke severity in atrial fibrillation. Stroke 1996; 27:1760-1764.
  8. Lamassa A et al. Characteristics, outcome, and care of stroke associated with atrial fibrillation in Europe. Stroke 2001; 32:392-398.
  9. Fuster, V et al. ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation: executive summary; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines and Policy Conferences. Circulation 2001;104:2118-2150.
  10. 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.
  11. Giugliano, R et al. Edoxaban versus Warfarin in patients with atrial fibrillation. N Engl J Med 2013;369:2093-2104.
  12. Büller, H et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013; 369:1406-1415.
  13. Daiichi Sankyo press release - Daiichi Sankyo launches LIXIANA® (edoxaban), a direct oral factor Xa inhibitor, in Japan for the prevention of venous thromboembolism after major orthopaedic surgery. 19 July 2011. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005784.html. [Last accessed: March 2014].

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
There's Big Data, then there's really Big Data from the Internet of Things. IoT is evolving to include many data possibilities like new types of event, log and network data. The volumes are enormous, generating tens of billions of logs per day, which raise data challenges. Early IoT deployments are relying heavily on both the cloud and managed service providers to navigate these challenges. In her session at Big Data Expo®, Hannah Smalltree, Director at Treasure Data, discussed how IoT, Big D...
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is obsolete...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
SYS-CON Media announced today that Skytap blog on "DevOps Journal" exceeded 84,000 story reads. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Noel Wurst is the managing content editor at Skytap. Skytap provides SaaS-based dev/test environments to the enterprise. Skytap solution removes the inefficiencies and constraints that comp...
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...