|By Marketwired .||
|March 30, 2014 11:30 AM EDT||
WASHINGTON, DC -- (Marketwired) -- 03/30/14 -- The Medicines Company (NASDAQ: MDCO) today reported a presentation of a pooled analysis of 5,800 patients in the EUROMAX and HORIZONS-AMI trials, two international clinical trials comparing Angiomax® (bivalirudin) versus heparin with or without glycoprotein IIb/IIIa inhibitors (GP IIb/IIIa) in patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI). EUROMAX and HORIZONS-AMI studies were presented and published individually in September 2008 and October 2013, in The Lancet and The New England Journal of Medicine respectively.
The pre-specified patient-level data from the EUROMAX and HORIZONS-AMI trials were presented today at the American College of Cardiology's (ACC) 63rd Annual Scientific Session in Washington, D.C.
Lead author, presenter and primary investigator of the EUROMAX trial Professor P. Gabriel Steg, MD, of Hôpital Bichat in Paris said, "The totality of the findings in this analysis confirm the earlier findings of the EUROMAX and HORIZONS-AMI trials, and support the fact that bivalirudin should remain the preferred anticoagulant of choice for clinicians treating STEMI patients undergoing primary PCI."
The totality of the data in the EUROMAX and HORIZONS-AMI trials of 5,800 STEMI patients undergoing primary PCI showed a significant absolute reduction in cardiac death of 0.9% (2.0% for bivalirudin vs. 2.9% for control; OR 0.70, 95% CI 0.50-0.97, p=0.03); absolute reduction in major non-CABG-related bleeding of 3.6% (4.2% for bivalirudin vs. 7.8% for control; OR 0.53, 95% CI 0.43-0.66, p= < 0.0001); absolute reduction in transfusion of 1.7% (2.1% for bivalirudin vs. 3.8% for control; OR 0.57, 95% CI 0.42-0.77, p=0.0002); and absolute reduction in net adverse clinical events (NACE) of 3.1% (8.8% for bivalirudin vs. 11.9% for control; OR 0.74, 95% CI 0.63-0.86, p= < 0.0001). The analysis also showed an increased risk of stent thrombosis, driven by an increase in acute stent thrombosis absolute risk of 1.0% (1.2% for bivalirudin vs. 0.2% for control; OR 6.04, 95% CI 2.55-14.31, p= < 0.0001). The findings were consistent across all examined subgroups.
"As we had seen in the results of the EUROMAX and HORIZONS-AMI trials when they were first presented and published, this analysis underscores that use of bivalirudin, compared with a combination of heparin and a GP IIb/IIIa inhibitor, is associated with significant absolute reductions in risk for cardiac death and major non-CABG bleeding," said Gregg W. Stone, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular therapy at New York-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation. Dr. Stone is the principal investigator of the HORIZONS-AMI trial.
In the United States, bivalirudin is marketed under the trade name Angiomax and is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
In Europe, Angiox currently is indicated as an anticoagulant for adult patients undergoing PCI, including patients with STEMI undergoing primary PCI. Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation MI planned for urgent or early intervention. Please see full prescribing information available at http://www.angiox.com.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28%). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Please see full prescribing information for Angiomax, available at http://www.angiomax.com.
EUROMAX (EUROpean aMbulance Acs angioX trial) was a 2,218 randomized, controlled, open label, international, multicenter study that compared early administration of bivalirudin, which is marketed as Angiox in the European Union, and Angiomax in the US, to heparins with or without glycoprotein inhibitors (GPI). Patients with ST-segment elevation myocardial infarction (STEMI) who were being transported for primary PCI received either bivalirudin or unfractionated or low-molecular-weight heparin with optional GPI (control group). At 30 days, the primary outcome was a composite of death or major bleeding not associated with coronary-artery bypass grafting (CABG), and the principal secondary outcome was a composite of death, reinfarction, or non-CABG major bleeding. Patients who were assigned to the bivalirudin group received a bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour, which should be continued for at least 4 hours after PCI. The protocol also specified that the dose during the post-PCI interval should be 0.25 mg per kilogram per hour; however, continuation of the higher dose used during PCI was also permitted. Bailout use of a GPI was allowed in the event of giant thrombus or no-reflow.
HORIZONS-AMI, co-funded by a grant from The Medicines Company, was the largest study to focus on the appropriate use of anticoagulation medications and stents in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI), commonly known as angioplasty. This landmark trial was a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax (bivalirudin) with provisional use of GPI or heparin plus GPI. Patients enrolled in the HORIZONS-AMI trial also were assigned randomly to receive either TAXUS® drug-eluting stents or a bare-metal stent.
The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary endpoint was major adverse cardiovascular events at 30 days.
About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether physicians, patients and other key decision makers will accept clinical trial results and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the SEC on March 3, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Neera Dahiya Ravindran, MD
Vice President, Investor Relations & Strategic Planning
The Medicines Company
+1 (973) 290-6044
SYS-CON Events announced today that 910Telecom 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. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 31, 2016 09:00 PM EDT Reads: 2,072
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...
Aug. 31, 2016 08:15 PM EDT Reads: 295
The Internet of Things can drive efficiency for airlines and airports. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Sudip Majumder, senior director of development at Oracle, will discuss the technical details of the connected airline baggage and related social media solutions. These IoT applications will enhance travelers' journey experience and drive efficiency for the airlines and the airports. The session will include a working demo and a technical d...
Aug. 31, 2016 07:00 PM EDT Reads: 257
Although it has gained significant traction in the consumer space, IoT is still in the early stages of adoption in enterprises environments. However, many companies are working on initiatives like Industry 4.0 that includes IoT as one of the key disruptive technologies expected to reshape businesses of tomorrow. The key challenges will be availability, robustness and reliability of networks that connect devices in a business environment. Software Defined Wide Area Network (SD-WAN) is expected to...
Aug. 31, 2016 06:15 PM EDT Reads: 298
Developing software for the Internet of Things (IoT) comes with its own set of challenges. Security, privacy, and unified standards are a few key issues. In addition, each IoT product is comprised of (at least) three separate application components: the software embedded in the device, the back-end service, and the mobile application for the end user’s controls. Each component is developed by a different team, using different technologies and practices, and deployed to a different stack/target –...
Aug. 31, 2016 05:15 PM EDT Reads: 295
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 31, 2016 04:45 PM EDT Reads: 3,849
As cloud adoption continues to transform business, today’s global enterprises are challenged with managing a growing amount of information living outside of the data center. The rapid adoption of IoT and increasingly mobile workforce are exacerbating the problem. Ensuring secure data sharing and efficient backup poses capacity and bandwidth considerations as well as policy and regulatory compliance issues.
Aug. 31, 2016 03:15 PM EDT Reads: 345
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Aug. 31, 2016 03:00 PM EDT Reads: 802
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.
Aug. 31, 2016 02:30 PM EDT Reads: 2,103
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 31, 2016 02:00 PM EDT Reads: 3,290
Data is an unusual currency; it is not restricted by the same transactional limitations as money or people. In fact, the more that you leverage your data across multiple business use cases, the more valuable it becomes to the organization. And the same can be said about the organization’s analytics. In his session at 19th Cloud Expo, Bill Schmarzo, CTO for the Big Data Practice at EMC, will introduce a methodology for capturing, enriching and sharing data (and analytics) across the organizati...
Aug. 31, 2016 11:00 AM EDT Reads: 497
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.
Aug. 31, 2016 10:45 AM EDT Reads: 481
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 31, 2016 09:30 AM EDT Reads: 1,137
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...
Aug. 31, 2016 09:00 AM EDT Reads: 572
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Aug. 31, 2016 08:45 AM EDT Reads: 943
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...
Aug. 31, 2016 07:45 AM EDT Reads: 985
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Aug. 31, 2016 02:45 AM EDT Reads: 1,923
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
Aug. 31, 2016 02:15 AM EDT Reads: 2,318
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 31, 2016 02:00 AM EDT Reads: 2,056
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Aug. 31, 2016 01:45 AM EDT Reads: 3,135