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 A 'half-hearted' solution to one-sided heart failure
24.11.2017 | Boston Children's Hospital

nachricht New study points the way to therapy for rare cancer that targets the young
22.11.2017 | Rockefeller University

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: New proton record: Researchers measure magnetic moment with greatest possible precision

High-precision measurement of the g-factor eleven times more precise than before / Results indicate a strong similarity between protons and antiprotons

The magnetic moment of an individual proton is inconceivably small, but can still be quantified. The basis for undertaking this measurement was laid over ten...

Im Focus: Frictional Heat Powers Hydrothermal Activity on Enceladus

Computer simulation shows how the icy moon heats water in a porous rock core

Heat from the friction of rocks caused by tidal forces could be the “engine” for the hydrothermal activity on Saturn's moon Enceladus. This presupposes that...

Im Focus: Nanoparticles help with malaria diagnosis – new rapid test in development

The WHO reports an estimated 429,000 malaria deaths each year. The disease mostly affects tropical and subtropical regions and in particular the African continent. The Fraunhofer Institute for Silicate Research ISC teamed up with the Fraunhofer Institute for Molecular Biology and Applied Ecology IME and the Institute of Tropical Medicine at the University of Tübingen for a new test method to detect malaria parasites in blood. The idea of the research project “NanoFRET” is to develop a highly sensitive and reliable rapid diagnostic test so that patient treatment can begin as early as possible.

Malaria is caused by parasites transmitted by mosquito bite. The most dangerous form of malaria is malaria tropica. Left untreated, it is fatal in most cases....

Im Focus: A “cosmic snake” reveals the structure of remote galaxies

The formation of stars in distant galaxies is still largely unexplored. For the first time, astron-omers at the University of Geneva have now been able to closely observe a star system six billion light-years away. In doing so, they are confirming earlier simulations made by the University of Zurich. One special effect is made possible by the multiple reflections of images that run through the cosmos like a snake.

Today, astronomers have a pretty accurate idea of how stars were formed in the recent cosmic past. But do these laws also apply to older galaxies? For around a...

Im Focus: Visual intelligence is not the same as IQ

Just because someone is smart and well-motivated doesn't mean he or she can learn the visual skills needed to excel at tasks like matching fingerprints, interpreting medical X-rays, keeping track of aircraft on radar displays or forensic face matching.

That is the implication of a new study which shows for the first time that there is a broad range of differences in people's visual ability and that these...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Ecology Across Borders: International conference brings together 1,500 ecologists

15.11.2017 | Event News

Road into laboratory: Users discuss biaxial fatigue-testing for car and truck wheel

15.11.2017 | Event News

#Berlin5GWeek: The right network for Industry 4.0

30.10.2017 | Event News

 
Latest News

IceCube experiment finds Earth can block high-energy particles from nuclear reactions

24.11.2017 | Physics and Astronomy

A 'half-hearted' solution to one-sided heart failure

24.11.2017 | Health and Medicine

Heidelberg Researchers Study Unique Underwater Stalactites

24.11.2017 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>