Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Apixaban superior to warfarin for preventing stroke, reducing bleeding and saving lives

29.08.2011
A large-scale trial finds that apixaban, a new anticoagulant drug, is superior to the standard drug warfarin for preventing stroke and systemic embolism in patients with atrial fibrillation. Moreover, apixaban results in substantially less bleeding and also results in lower mortality.

The results were presented by Duke University Medical Center researchers at the European Society of Cardiology in Paris, France, today, and published simultaneously online in the New England Journal of Medicine.

"These are important findings because they show that, when compared to warfarin, a very effective treatment to prevent stroke, apixaban resulted in an additional 21 percent relative reduction in stroke or systemic embolism," says Christopher B. Granger, M.D., the study's lead author and professor of medicine at Duke. "It also resulted in a 31 percent relative reduction in major bleeding, as well as an 11 percent relative reduction in overall mortality."

The improvement in stroke prevention was statistically significant with P=0.011, the lower rate of major bleeding at P

The randomized, double-blind clinical trial known as ARISTOTLE randomized 18,201 patients at 1034 clinical sites in 39 countries, giving them either 5 mg twice daily of apixaban or warfarin for an average of 1.8 years.

Apixaban has several major practical advantages over warfarin in addition to the therapeutic benefits, says John Alexander, M.D., a study co-author and Duke cardiologist. "It does not require monitoring and has few interactions with other medications or food. Apixaban was better tolerated than warfarin, with fewer discontinuations."

The benefits of reducing stroke and lower rates of bleeding were consistent across all major subgroups, and despite the heterogeneity that exists in the quality of warfarin use across the world, says Alexander.

The number of events prevented per 1,000 people, which indicate absolute risk reduction, was also impressive, says Alexander. Apixaban prevented 6 patients from having a stroke, 15 patients from having major bleeding, and 8 patients from dying. The major effect on stroke prevention was on hemorrhagic stroke. Apixaban prevented 4 patients from having hemorrhagic stroke and 2 patients from having an ischemic or uncertain type of stroke.

Atrial fibrillation is a common abnormal heart rhythm that affects more than 2.6 million Americans. It occurs when the heart's electrical activity becomes disorganized, resulting in an irregular heartbeat with ineffective contraction of the upper chambers of the heart. The potential for blood clots to form, and one's risk for stroke, increases as a result.

Warfarin is a vitamin K antagonist that is well documented for its ability to prevent blood clots. Previous studies indicate that long-term use of warfarin in patients with atrial fibrillation and other stroke risk factors can reduce stroke by up to 70 percent. But only about half of patients who could benefit from warfarin actually do. Patients on warfarin must have regular blood tests to monitor and adjust the dose and avoid certain foods and medications that interfere with warfarin's effect. Warfarin also increases bleeding rusj including including intracranial hemorrhage.

"There is an enormous unmet need for treatment of patients at risk for stroke associated with atrial fibrillation," says Granger. "Only about half of patients who should be treated are being treated. The disparity exists because warfarin treatment has several limitations."

Doctors and patients have been eagerly awaiting alternative therapies to warfarin, one of which is currently available. Several others are currently under investigation in large clinical trials.

Apixaban is an oral direct factor Xa inhibitor that showed promise last year when trial findings presented at the European Society of Cardiology showed apixaban patients were 54 percent less likely to have a stroke or blood clot than those who took aspirin. Apixaban and aspirin showed similar risks of major bleeding.

"Our study indicates treatment with apixaban is more effective than warfarin in preventing stroke without the need for anticoagulation monitoring," says Lars Wallentin, M.D., the study committee's co-chair, professor of cardiology, and director of the Uppsala Clinical Research Center University Hospital in Sweden.

The study also shows apixaban is safer than warfarin, according to Wallentin. "Our findings show a single dose of apixaban accomplishes the same stroke prevention goal as adjusted-dose warfarin with a substantially lower risk of all types of bleeding across different ages, and with lower rates of discontinuation."

The study was coordinated by Uppsala Clinical Research Institute, Sweden and the Duke Clinical Research Institute.

It was funded by Bristol-Myers Squibb, Co and Pfizer Inc.

Additional study authors include: John J. V. McMurray, M.D., Cardiovascular Research Centre, University of Glasgow; Renato Lopes, DCRI; Elaine Hylek, Boston University; Michael Hanna, BMS; Hussein Al-Khalidi, DCRI; Jack Ansell, Lenox Hill Hospital; Dan Atar, Oslo University Hospital; Alvaro Avezum, Dante Pazzanese Institute of Cardiology; M. Bahit, ECLA Estudios Cardiologicos Latinoamerica; Rafael Diaz, ECLA Estudios Cardiologicos Latinoamerica; J. Donald Easton, Brown University; Justin Ezekowitz, University of Alberta; Greg Flaker, University of Missouri Health Care; David Garcia, University of New Mexico; Margarida Geraldes, BMS; Bernard Gersh, Mayo Clinic; Sergey Golitsyn, Russian Cardiology Research Center; Shinya Goto, Tokai University School of Medicine; J. Antonio Gonzalez-Hermosillo; Instituo N de Cardiologia Ignacio Chavez; Stefan Hohnloser, J.W. Goethe University; John Horowitz, University of Adelaide; Puneet Mohan, BMS; Petr Jansky, Motol University Hospital; Basil Lewis, Lady Davis Carmel Medical Center; Jose Lopez-Sendon, La Paz University Hospital; Prem Pais, St. John's Medical College; Alexander Parkhomenko, Institute of Cardiology; Freek Verheugt, Radboud University Nijmegen Medical Centre; Jun Zhu, Fuwai Hospital

Debbe Geiger | EurekAlert!
Further information:
http://www.duke.edu

More articles from Health and Medicine:

nachricht Correct connections are crucial
26.06.2017 | Charité - Universitätsmedizin Berlin

nachricht One gene closer to regenerative therapy for muscular disorders
01.06.2017 | Cincinnati Children's Hospital Medical Center

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Can we see monkeys from space? Emerging technologies to map biodiversity

An international team of scientists has proposed a new multi-disciplinary approach in which an array of new technologies will allow us to map biodiversity and the risks that wildlife is facing at the scale of whole landscapes. The findings are published in Nature Ecology and Evolution. This international research is led by the Kunming Institute of Zoology from China, University of East Anglia, University of Leicester and the Leibniz Institute for Zoo and Wildlife Research.

Using a combination of satellite and ground data, the team proposes that it is now possible to map biodiversity with an accuracy that has not been previously...

Im Focus: Climate satellite: Tracking methane with robust laser technology

Heatwaves in the Arctic, longer periods of vegetation in Europe, severe floods in West Africa – starting in 2021, scientists want to explore the emissions of the greenhouse gas methane with the German-French satellite MERLIN. This is made possible by a new robust laser system of the Fraunhofer Institute for Laser Technology ILT in Aachen, which achieves unprecedented measurement accuracy.

Methane is primarily the result of the decomposition of organic matter. The gas has a 25 times greater warming potential than carbon dioxide, but is not as...

Im Focus: How protons move through a fuel cell

Hydrogen is regarded as the energy source of the future: It is produced with solar power and can be used to generate heat and electricity in fuel cells. Empa researchers have now succeeded in decoding the movement of hydrogen ions in crystals – a key step towards more efficient energy conversion in the hydrogen industry of tomorrow.

As charge carriers, electrons and ions play the leading role in electrochemical energy storage devices and converters such as batteries and fuel cells. Proton...

Im Focus: A unique data centre for cosmological simulations

Scientists from the Excellence Cluster Universe at the Ludwig-Maximilians-Universität Munich have establised "Cosmowebportal", a unique data centre for cosmological simulations located at the Leibniz Supercomputing Centre (LRZ) of the Bavarian Academy of Sciences. The complete results of a series of large hydrodynamical cosmological simulations are available, with data volumes typically exceeding several hundred terabytes. Scientists worldwide can interactively explore these complex simulations via a web interface and directly access the results.

With current telescopes, scientists can observe our Universe’s galaxies and galaxy clusters and their distribution along an invisible cosmic web. From the...

Im Focus: Scientists develop molecular thermometer for contactless measurement using infrared light

Temperature measurements possible even on the smallest scale / Molecular ruby for use in material sciences, biology, and medicine

Chemists at Johannes Gutenberg University Mainz (JGU) in cooperation with researchers of the German Federal Institute for Materials Research and Testing (BAM)...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Plants are networkers

19.06.2017 | Event News

Digital Survival Training for Executives

13.06.2017 | Event News

Global Learning Council Summit 2017

13.06.2017 | Event News

 
Latest News

Study shines light on brain cells that coordinate movement

26.06.2017 | Life Sciences

Smooth propagation of spin waves using gold

26.06.2017 | Physics and Astronomy

Switchable DNA mini-machines store information

26.06.2017 | Information Technology

VideoLinks
B2B-VideoLinks
More VideoLinks >>>