SATURDAY, Dec. 8 (HealthDay News) -- The new anti-clotting drug
apixaban (Eliquis) appears to help prevent potentially fatal blood
clots in patients with deep vein thrombosis (DVT), a new Italian
People who suffer from venous thromboembolism are prone to
develop blood clots in the veins in their legs (DVT). If a clot
breaks loose, it can travel to the heart and cause a heart attack,
or the brain and cause a stroke, or to the lungs and cause severe
breathing difficulties, and even death.
"This finding is great," said Dr. Maja Zaric, an interventional cardiologist at Lenox Hill Hospital in New York City.
Currently, patients with recurrent venous thromboembolism take a
drug called warfarin, which is effective but needs careful
monitoring and is associated with a risk of major, and sometimes
This drug and others will likely replace warfarin over the next
few years, Zaric said. These drugs do not require weekly or monthly
blood tests, which is a major problem for many patients, she
"One drawback of apixaban is having to take two doses a day," Zaric said. "This can make patient compliance less effective. The drug that will be the one most used is the cheapest one that only has to be taken once a day."
Although apixaban and other drugs in its class cost more
initially, not having to make frequent doctor visits to check
medication levels along with not having as many severe bleeding
episodes as with warfarin will save more in the long run, Zaric
"It's cheaper to spend a little more on a drug than a lot on doctor's visits and hospitalizations," Zaric said.
A month's treatment with warfarin costs about $35 in Canada,
where apixaban is available with a monthly price tag of $290,
according to the Canadian drug index of Rx List.
The findings were published online Dec. 8 in the
New England Journal of Medicine, to coincide with a planned
presentation at the American Society of Hematology annual meeting
Dr. Giancarlo Agnelli, director of the department of internal
and cardiovascular medicine and stroke unit at Perugia University
Hospital in Italy, and his colleagues randomly assigned almost
2,500 patients to one of three regimens for a year.
Patients were either given 2.5 milligrams (mg) of apixaban twice
daily, 5 mg of apixaban twice daily or an inactive placebo. Over
the course of the trial, the researchers looked for recurrent
venous thromboembolism, deaths from venous thromboembolism or
cardiovascular problems and major bleeding.
The investigators found that either dose of apixaban reduced the
risk of recurrent venous thromboembolism and venous
thromboembolism-related death by about 80 percent, compared with
While almost 9 percent of those receiving placebo had one of
these events, only 1.7 percent of those taking apixaban did, the
In addition, either dose of apixaban reduced the risk of stroke,
heart attack and cardiovascular-related death. Major bleeding was
similar for those taking apixaban and those receiving placebo, the
"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 [venous thromboembolism]," Agnelli said in a statement.
"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," he added.
The trial was funded by the developers of apixaban,
Bristol-Myers Squibb and Pfizer. Although the drug has not yet been
approved by the U.S. Food and Drug Administration, a decision is
expected in March, according to the agency. Approval was delayed
because the FDA asked for more data.
Drugs similar to apixaban include Xarelto (rivaroxaban) and
Pradaxa (dabigatran etexilate), both of which have been approved by
According to the U.S. Centers for Disease Control and
Prevention, about one-third of patients who have suffered venous
thromboembolism have a recurrence within 10 years.
Another expert, Dr. Gregg Fonarow, a professor of cardiology at
the University of California, Los Angeles, said that "after venous
thromboembolism, it is recommended that patients be treated with
anticoagulation therapy for six to 12 months. However, the benefits
and risks of extended treatment with new oral anticoagulant agents
are unclear. Given the highly favorable benefit/risk ratio, the
extended treatment approach may represent an important therapeutic
For more information on venous thromboembolism , visit the
U.S. National Library of Medicine.
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