|By PR Newswire||
|December 8, 2012 02:00 PM EST||
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. 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.
 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
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Dec. 8, 2016 04:45 PM EST Reads: 2,242
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Dec. 8, 2016 04:45 PM EST Reads: 1,821
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
Dec. 8, 2016 04:15 PM EST Reads: 2,305
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
Dec. 8, 2016 03:48 PM EST Reads: 206
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Dec. 8, 2016 03:30 PM EST Reads: 1,210
Unsecured IoT devices were used to launch crippling DDOS attacks in October 2016, targeting services such as Twitter, Spotify, and GitHub. Subsequent testimony to Congress about potential attacks on office buildings, schools, and hospitals raised the possibility for the IoT to harm and even kill people. What should be done? Does the government need to intervene? This panel at @ThingExpo New York brings together leading IoT and security experts to discuss this very serious topic.
Dec. 8, 2016 03:00 PM EST Reads: 507
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Dec. 8, 2016 02:30 PM EST Reads: 912
"Dice has been around for the last 20 years. We have been helping tech professionals find new jobs and career opportunities," explained Manish Dixit, VP of Product and Engineering at Dice, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 02:15 PM EST Reads: 1,178
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
Dec. 8, 2016 02:00 PM EST Reads: 214
"ReadyTalk is an audio and web video conferencing provider. We've really come to embrace WebRTC as the platform for our future of technology," explained Dan Cunningham, CTO of ReadyTalk, in this SYS-CON.tv interview at WebRTC Summit at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 01:45 PM EST Reads: 779
"At ROHA we develop an app called Catcha. It was developed after we spent a year meeting with, talking to, interacting with senior citizens watching them use their smartphones and talking to them about how they use their smartphones so we could get to know their smartphone behavior," explained Dave Woods, Chief Innovation Officer at ROHA, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 01:45 PM EST Reads: 750
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
Dec. 8, 2016 12:45 PM EST Reads: 1,743
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Dave McCarthy, Director of Products at Bsquare Corporation; Alan Williamson, Principal...
Dec. 8, 2016 12:00 PM EST Reads: 510
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, 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.
Dec. 8, 2016 11:30 AM EST Reads: 2,340
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Dec. 8, 2016 10:30 AM EST Reads: 7,318
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for ...
Dec. 8, 2016 10:30 AM EST Reads: 544
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 8, 2016 10:00 AM EST Reads: 1,000
Dec. 8, 2016 09:45 AM EST Reads: 1,947
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
Dec. 8, 2016 09:30 AM EST Reads: 643
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Dec. 8, 2016 09:15 AM EST Reads: 968