Welcome!

Web 2.0 Authors: Scott Bampton, Paige Leidig, Pat Romanski, Carmen Gonzalez, Liz McMillan

News Feed Item

Studies Challenge Standards to Improve Treatment Outcomes for Patients with Clotting Disorders

ATLANTA, Dec. 8, 2012 /PRNewswire-USNewswire/ -- Studies presented today at the 54th Annual Meeting of the American Society of Hematology (ASH) examine current treatment standards for patients with clotting disorders in an effort to improve outcomes. The studies evaluate long-held treatment standards and whether modifications in intensity and duration of therapy may offer equally effective outcomes while reducing toxicities and relapse rates. 

Although significant advances have been made in delivering new and improved therapies for clotting disorders, treatment still presents challenges; patients must balance the burden of therapy and risk of treatment-related bleeding with the threat of potentially life-threatening clotting. The studies presented today examine how simple strategies in the treatment of polycythemia vera (PV) and venous thromboembolism (VTE) may be safe and help produce more effective results in patients with these disorders.

"It is important to constantly evaluate and challenge standard treatment protocols to ensure that we are utilizing the best possible strategies to treat patients with these serious disorders," said Agnes Y. Lee, MD, moderator of the press conference and Medical Director of the Thrombosis Program and Associate Professor of Medicine at the University of British Columbia and Vancouver Coastal Health in Canada. "Additionally, as we are seeing an increasing number of patients who require ongoing, long-term treatment, it is important to find new ways to improve efficacy and lower the risks of potentially life-threatening complications that accompany these aggressive therapies."

This press conference will take place on Saturday, December 8, 2012, at 2:00 p.m. EST.

A Large-Scale Trial Testing the Intensity of Cytoreductive Therapy to Prevent Cardiovascular Events in Patients with Polycythemia Vera (CYTO-PV trial) [Abstract 4]

In the first randomized clinical trial assessing the proper target hematocrit level, or percentage of red blood cells that should be maintained in patients with polycythemia vera (PV), researchers have concluded that the current recommendation to maintain a hematocrit level of less than 45 percent is associated with a lower risk of thrombosis compared with a less aggressive treatment strategy of maintaining a hematocrit level between 45 and 50 percent.

PV is a rare blood disorder that causes the bone marrow to produce too many red blood cells, making the blood much thicker.This can dramatically increase the risk of blood clots such as deep-vein thrombosis (DVT, a blood clot that forms in a vein deep in the legs) or pulmonary embolism (PE, a blood clot in the lung) and cardiovascular events such as heart attack or stroke. Because thrombosis is the most common cause of death in patients with PV, prompt diagnosis and treatment to reduce the thickness of the blood is critical.

Patients with PV usually have elevated hematocrit levels (approximately 50 to 70%, compared with less than 50% in the general population), which puts them at a higher risk of suffering heart attacks, strokes, and DVT/PE than the general population. In order to reduce this risk, a hematocrit level of less than 45 percent is recommended and initially maintained through phlebotomies. If the hematocrit level cannot be reduced through multiple phlebotomies or disease progression is documented, patients receive hydroxyurea or chemotherapy to eliminate the excess red blood cells. While these two treatment strategies have become widely accepted for PV, until recently no prospective randomized clinical trial has confirmed whether tight control of hematocrit levels below 45 percent successfully prevents or reduces blood clots in patients with PV.

In order to assess the efficacy and safety of maintaining a hematocrit level of lower than 45 percent versus a more liberal approach (keeping hematocrit levels between 45 and 50%), investigators from Italy conducted a study comparing the two strategies among 365 patients with newly diagnosed PV. Patients in Arm A were treated aggressively to maintain hematocrit levels at less than 45 percent, while the patients in Arm B were treated to maintain levels between 45 and 50 percent. The primary composite endpoint was major clots, including stroke, heart attack, transient ischemic attacks ("mini strokes"), clots in the veins in the abdomen, DVT or PE, and cardiovascular death.

The investigators observed that the risk of developing major clots was four times higher in those patients whose hematocrit levels were kept between 45 and 50 percent than in patients whose levels were kept below 45 percent. With the more intensive regimen in Arm A, 1.1 percent of the patients had a major clot versus 4.4 percent in the less aggressive regimen in Arm B. The median hematocrit levels during follow-up were 44 percent and 48 percent, respectively. Treatment with phlebotomy, anti-clotting drugs, and hydroxyurea were comparable.

There was no difference in the safety profile between the regimens. Six patients in Arm A and one patient in Arm B developed myelofibrosis, a blood disorder that causes the bone marrow to be replaced by scar tissue. Researchers observed no statistical difference in the frequency of acute leukemias that occurred in three patients in Arm A and one patient in Arm B. 

"These data validate the notion that it is important to keep hematocrit levels below 45 percent for this population of patients who are at a high risk of developing clotting complications," said Tiziano Barbui, MD, lead author and Professor of Hematology and Scientific Director of the Research Foundation at Ospedali Riuniti di Bergamo in Italy. "The results from our study will be especially important in the development of new drugs for polycythemia vera, as we look to maintain these levels more effectively and with minimal complications."

Dr. Barbui will present this study during the Plenary Scientific Session on Sunday, December 9 at 3:05 p.m. EST at the Georgia World Congress Center in Hall B5, Level 1, Building B.

Two Doses of Apixaban for the Extended Treatment of Venous Thromboembolism [LBA 1]

A large study has found that the new oral anticoagulant apixaban, given at fixed doses without laboratory monitoring, may provide a simple, effective, and safe strategy for the long-term management of venous thromboembolism (VTE). Data showed that apixaban dramatically reduced patients' risk of developing potentially fatal clots without increasing their rate of major bleeding events. 

VTE is the collective name for blood clots in the deep veins of the legs (deep-vein thrombosis or DVT) or lungs (pulmonary embolism). According to the Centers for Disease Control and Prevention, approximately one-third of patients who have suffered a VTE have a recurrence within 10 years.[1] Current VTE treatments include anticoagulant drugs such as warfarin, dabigatran, and rivaroxaban that prevent blood clots from forming or growing larger. While warfarin is effective, it requires regular blood testing and dose adjustment and is associated with the risk of uncontrolled bleeding. Attempts to reduce the intensity of the anticoagulation effect of warfarin (as well as dabigatran and rivaroxaban) to lower the risk of bleeding have been ineffective, as the reduction only led to more frequent recurrent VTE without reducing bleeding risk.

While warfarin reduces the activity of several blood clotting factors, apixaban is different in that it specifically targets the activated factor X, a critically important enzyme responsible for the formation of blood clots. Also unlike warfarin, apixaban can be given in fixed doses and does not require routine laboratory monitoring. Previous studies demonstrate that patients who received a fixed, 2.5 mg dose of apixaban twice daily to prevent VTE after major orthopedic surgery experienced similar outcomes as those who received low-molecular-weight heparin (an injectible anticoagulant). Recent data also show that a twice-daily, 5.0 mg dose of apixaban was safer and more effective than warfarin to prevent stroke in patients with an irregular heart rhythm called atrial fibrillation.

To evaluate whether apixaban may be an effective and safe treatment option for the prevention of recurrent VTE, researchers initiated the AMPLIFY-Extension study, which randomized 2,500 patients with VTE who had already completed a 6-to-12 month course of anticoagulant therapy to receive one of three regimens – apixaban 2.5 mg twice daily, apixaban 5.0 mg twice daily, or placebo – for 12 months. The primary efficacy and safety study endpoints were rates of symptomatic, recurrent VTE; VTE – or cardiovascular-related death; and major bleeding.

Compared to placebo, both doses of apixaban reduced the risk of recurrent VTE and VTE-related death in study participants by approximately 80 percent. While 8.8 percent of the placebo group experienced recurrent VTE or VTE-related death, only 1.7 percent of patients in either the low-dose or high-dose apixaban groups experienced the same outcome. Treatment at either dose also reduced cardiovascular events, including stroke, heart attack, and cardiovascular-related death. Major bleeding rates associated with both the 2.5 mg and 5.0 doses of apixaban were similar to placebo (0.2%, 0.1% and 0.5%, respectively), demonstrating the safety of both doses of apixaban as a long-term VTE therapy. 

"These results indicate that apixaban – at both low and high doses – provides an attractive risk-benefit profile for use as an ongoing treatment option in patients at risk of recurrent VTE," said Giancarlo Agnelli, MD, lead author and Chair of the Steering Committee of AMPLIFY-Extension, Professor of Internal Medicine and Director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit at Perugia University Hospital in Italy. "This regimen has the potential to eliminate many of the challenges we face when we treat patients with warfarin, including drug and food interactions and the need for ongoing monitoring, which can greatly simplify ongoing management of this condition." 

Dr. Agnelli will present this study during the Late-Breaking Abstracts session on Tuesday, December 11, at 7:30 a.m. EST at the Georgia World Congress Center in Hall B5, Level 1, Building B.

American Society of Hematology 54th Annual Meeting
The study authors and moderator will be available for interviews after the press conference or by telephone. Additional press briefings will take place throughout the meeting on new targeted treatment for chronic lymphocytic leukemia (CLL) and hard-to-treat blood disorders, efforts to reduce toxicity and improve survival for blood cancer therapy, and advances in stem cell technology and transplant strategies. For the complete annual meeting program and abstracts, visit www.hematology.org/2012abstracts. Follow ASH (@ASH_hematology) on Twitter (use the hashtag #ASH12 when posting tweets about the meeting) and on Facebook at www.facebook.com/AmericanSocietyofHematology for the most up-to-date information about the 2012 ASH Annual Meeting.

The American Society of Hematology (ASH) (www.hematology.org) is the world's largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. For more than 50 years, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. The official journal of ASH is Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field, which is available weekly in print and online.


[1] Center for Disease Control and Prevention, "Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE): Data & Statistics," http://www.cdc.gov/NCBDDD/dvt/data.html (Accessed November 2012).

SOURCE American Society of Hematology

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.

@ThingsExpo Stories
SYS-CON Events announced today that Gridstore™, the leader in software-defined storage (SDS) purpose-built for Windows Servers and Hyper-V, will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Gridstore™ is the leader in software-defined storage purpose built for virtualization that is designed to accelerate applications in virtualized environments. Using its patented Server-Side Virtual Controller™ Technology (SVCT) to eliminate the I/O blender effect and accelerate applications Gridsto...
SYS-CON Events announces a new pavilion on the Cloud Expo floor where WebRTC converges with the Internet of Things. Pavilion will showcase WebRTC and the Internet of Things. 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--computers, smartphones, tablets, and sensors – connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades.
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, will examine 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 storage designed to handle the massive surge in back-end data in a world where timely analytics...
Internet of @ThingsExpo Silicon Valley announced on Thursday its first 12 all-star speakers and sessions for its upcoming event, which will take place November 4-6, 2014, at the Santa Clara Convention Center in California. @ThingsExpo, the first and largest IoT event in the world, debuted at the Javits Center in New York City in June 10-12, 2014 with over 6,000 delegates attending the conference. Among the first 12 announced world class speakers, IBM will present two highly popular IoT sessions, which will take place November 4-6, 2014 at the Santa Clara Convention Center in Santa Clara, Calif...
The Internet of Things (IoT) promises to evolve the way the world does business; however, understanding how to apply it to your company can be a mystery. Most people struggle with understanding the potential business uses or tend to get caught up in the technology, resulting in solutions that fail to meet even minimum business goals. In his session at Internet of @ThingsExpo, Jesse Shiah, CEO / President / Co-Founder of AgilePoint Inc., will show what is needed to leverage the IoT to transform your business. He will discuss opportunities and challenges ahead for the IoT from a market and tec...
SYS-CON Events announced today that TeleStax, the main sponsor of Mobicents, will exhibit at Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. TeleStax provides Open Source Communications software and services that facilitate the shift from legacy SS7 based IN networks to IP based LTE and IMS networks hosted on private (on-premise), hybrid or public clouds. TeleStax products include Restcomm, JSLEE, SMSC Gateway, USSD Gateway, SS7 Resource Adaptors, SIP Servlets, Rich Multimedia Services, Presence Services/RCS, Diame...
From a software development perspective IoT is about programming "things," about connecting them with each other or integrating them with existing applications. In his session at @ThingsExpo, Yakov Fain, co-founder of Farata Systems and SuranceBay, will show you how small IoT-enabled devices from multiple manufacturers can be integrated into the workflow of an enterprise application. This is a practical demo of building a framework and components in HTML/Java/Mobile technologies to serve as a platform that can integrate new devices as they become available on the market.
SYS-CON Events announced today that O'Reilly Media has been named “Media Sponsor” of SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. O'Reilly Media spreads the knowledge of innovators through its books, online services, magazines, and conferences. Since 1978, O'Reilly Media has been a chronicler and catalyst of cutting-edge development, homing in on the technology trends that really matter and spurring their adoption by amplifying "faint signals" from the alpha geeks who are creating the future. An...
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.
SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue business and deliver exceptional experiences to their customers.
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce the value of the network in helping organizations to maximize their company’s cloud experience.
As a disruptive technology, Web Real-Time Communication (WebRTC), which is an emerging standard of web communications, is redefining how brands and consumers communicate in real time. The on-going narrative around WebRTC has largely been around incorporating video, audio and chat functions to apps. In his session at Internet of @ThingsExpo, Alex Gouaillard, Founder and CTO of Temasys Communications, will look at a fourth element – data channels – and talk about its potential to move WebRTC beyond browsers and into the Internet of Things.
SYS-CON Events announced today that Gigaom Research has been named "Media Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Ashar Baig, Research Director, Cloud, at Gigaom Research, will also lead a Power Panel on the topic "Choosing the Right Cloud Option." Gigaom Research provides timely, in-depth analysis of emerging technologies for individual and corporate subscribers. Gigaom Research's network of 200+ independent analysts provides new content daily that bridges the gap between break...
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, data security and privacy.
Swiss innovators dizmo Inc. launches its ground-breaking software, which turns any digital surface into an immersive platform. The dizmo platform seamlessly connects digital and physical objects in the home and at the workplace. Dizmo breaks down traditional boundaries between device, operating systems, apps and software, transforming the way users work, play and live. It supports orchestration and collaboration in an unparalleled way enabling any data to instantaneously be accessed on any surface, anywhere and made interactive. Dizmo brings fantasies as seen in Sci-fi movies such as Iro...
Software AG helps organizations transform into Digital Enterprises, so they can differentiate from competitors and better engage customers, partners and employees. Using the Software AG Suite, companies can close the gap between business and IT to create digital systems of differentiation that drive front-line agility. We offer four on-ramps to the Digital Enterprise: alignment through collaborative process analysis; transformation through portfolio management; agility through process automation and integration; and visibility through intelligent business operations and big data.
One of the biggest challenges when developing connected devices is identifying user value and delivering it through successful user experiences. In his session at Internet of @ThingsExpo, Mike Kuniavsky, Principal Scientist, Innovation Services at PARC, will describe an IoT-specific approach to user experience design that combines approaches from interaction design, industrial design and service design to create experiences that go beyond simple connected gadgets to create lasting, multi-device experiences grounded in people’s real needs and desires.
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at Internet of @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, will discuss how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money! Speaker Bio: Esmeralda Swartz, CMO of MetraTech, has spent 16 years as a marketing, product management, and busin...
As the Internet of Things unfolds, mobile and wearable devices are blurring the line between physical and digital, integrating ever more closely with our interests, our routines, our daily lives. Contextual computing and smart, sensor-equipped spaces bring the potential to walk through a world that recognizes us and responds accordingly. We become continuous transmitters and receivers of data. In his session at Internet of @ThingsExpo, Andrew Bolwell, Director of Innovation for HP’s Printing and Personal Systems Group, will discuss how key attributes of mobile technology – touch input, senso...