Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Treating blood clots, a half-century later

30.10.2003


The first new oral drug in 50 years to prevent blood clots after knee-replacement surgery was superior to the standard treatment in a clinical trial of about 2,300 patients led by the University of Rochester Medical Center.



Researchers also have tested the new drug, ximelagatran, for prevention of stroke, heart attacks and deep vein thrombosis, and if approved by the FDA it would offer millions of patients an alternative to the commonly prescribed anticoagulant, warfarin.

Results of the UR study are reported in the Oct. 30, 2003, New England Journal of Medicine, which in this issue paid special attention to scientific advances in the treatment of blood clots, or thrombosis. Two other major clinical trials also are reported.


Lead author Charles W. Francis, M.D., University of Rochester professor of Medicine and Pathology and Laboratory Medicine, says ximelagatran has now been studied in some 17,000 patients during the past five years. Ximelagatran was developed as an alternative to oral warfarin (brand name: Coumadin), in an effort to find a drug that was easier for patients and doctors to manage. Warfarin requires constant laboratory monitoring, and has a long list of side effects and food and drug interactions. Studies show ximelagatran is absorbed quickly, does not require adjustments or close monitoring, and has no food or drug interactions.

"Coumadin is a fine drug, but lots of people don’t do well on it," Francis says. "We’ve been 50 years with no alternative and now it looks like we have one."

Blood clots occur in 40 to 80 percent of patients after total knee replacement surgery; clots are also a serious risk for the one-to-two million Americans a year diagnosed with atrial fibrillation, a heart rhythm disorder, or who suffer heart attacks. In addition, doctors treat a half-million individuals annually for deep-vein thrombosis or pulmonary embolisms, and thousands of others need prophylactic therapy. All of these patients take anticoagulants.

Francis led previous studies of ximelagatran to prevent clots from developing in the leg veins after knee surgery. The purpose of the latest research, the largest study to date, was to determine if a higher dose (36 mg twice daily versus 24 mg) would be safe and even more effective. AstraZeneca PLC, the maker of ximelagatran, sponsored the research.

Francis’ randomized, double-blind Phase III trial took place at 116 medical centers in the United States, Canada, Israel, Mexico and Brazil. Researchers compared seven to 12 days of oral ximelagatran, at two different doses, starting the morning after knee surgery, with warfarin begun the day of surgery. Among the 608 patients in the warfarin group, 27.6 percent developed blood clots. In the higher-dose ximelagatran group (629 patients), 20.3 percent developed clots. Of the 614 patients in the lower-dose ximelagatran group, 24.9 percent developed clots. Statistically, therefore, the new drug was significantly superior to warfarin for prevention of venous thromboembolism, the study concluded.

There were no significant differences in the groups for bleeding after surgery, or wound healing. The most common post-operative complication was anemia, which occurred in eight-to-10 percent of the patients in each group. The biggest concern about ximelagatran, Francis says, is that in other studies of longer duration, some patients showed liver-function abnormalities. When the drug was discontinued, liver function returned to normal, he said.

Leslie Orr | EurekAlert!
Further information:
http://www.urmc.rochester.edu/

More articles from Health and Medicine:

nachricht Spanish scientists create a 3-D bioprinter to print human skin
24.01.2017 | Carlos III University of Madrid

nachricht Tracking movement of immune cells identifies key first steps in inflammatory arthritis
23.01.2017 | Massachusetts General Hospital

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: Scientists spin artificial silk from whey protein

X-ray study throws light on key process for production

A Swedish-German team of researchers has cleared up a key process for the artificial production of silk. With the help of the intense X-rays from DESY's...

Im Focus: Quantum optical sensor for the first time tested in space – with a laser system from Berlin

For the first time ever, a cloud of ultra-cold atoms has been successfully created in space on board of a sounding rocket. The MAIUS mission demonstrates that quantum optical sensors can be operated even in harsh environments like space – a prerequi-site for finding answers to the most challenging questions of fundamental physics and an important innovation driver for everyday applications.

According to Albert Einstein's Equivalence Principle, all bodies are accelerated at the same rate by the Earth's gravity, regardless of their properties. This...

Im Focus: Traffic jam in empty space

New success for Konstanz physicists in studying the quantum vacuum

An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...

Im Focus: How gut bacteria can make us ill

HZI researchers decipher infection mechanisms of Yersinia and immune responses of the host

Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Sustainable Water use in Agriculture in Eastern Europe and Central Asia

19.01.2017 | Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

 
Latest News

Breaking the optical bandwidth record of stable pulsed lasers

24.01.2017 | Physics and Astronomy

Choreographing the microRNA-target dance

24.01.2017 | Life Sciences

Spanish scientists create a 3-D bioprinter to print human skin

24.01.2017 | Health and Medicine

VideoLinks
B2B-VideoLinks
More VideoLinks >>>