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 Norovirus evades immune system by hiding out in rare gut cells
12.10.2017 | University of Pennsylvania School of Medicine

nachricht Flexible sensors can detect movement in GI tract
11.10.2017 | Massachusetts Institute of Technology

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: Breaking: the first light from two neutron stars merging

Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.

Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....

Im Focus: Smart sensors for efficient processes

Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).

When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...

Im Focus: Cold molecules on collision course

Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.

How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...

Im Focus: Shrinking the proton again!

Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.

It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...

Im Focus: New nanomaterial can extract hydrogen fuel from seawater

Hybrid material converts more sunlight and can weather seawater's harsh conditions

It's possible to produce hydrogen to power fuel cells by extracting the gas from seawater, but the electricity required to do it makes the process costly. UCF...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ASEAN Member States discuss the future role of renewable energy

17.10.2017 | Event News

World Health Summit 2017: International experts set the course for the future of Global Health

10.10.2017 | Event News

Climate Engineering Conference 2017 Opens in Berlin

10.10.2017 | Event News

 
Latest News

Plant escape from waterlogging

17.10.2017 | Life Sciences

Study suggests oysters offer hot spot for reducing nutrient pollution

17.10.2017 | Life Sciences

Breaking: the first light from two neutron stars merging

17.10.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>