WEDNESDAY, Dec. 22 (HealthDay News) -- A new drug, apixaban, may
be better for preventing dangerous blood clots in the legs and
lungs after hip replacement surgery than a commonly used older
drug, a new study finds.
Researchers in Denmark compared the two anti-clotting drugs in a
head-to-head test involving about 5,400 hip replacement
About 3.9 percent of patients given the older drug, enoxaparin,
developed venous thromboembolism (clot in the legs), a pulmonary
embolism (clot in the lungs) or died after the surgery, according
to the study.
That compares to only 1.4 percent of patients given
Apixaban is being developed by Bristol-Myers Squibb and Pfizer,
which funded the Phase III trial reported in the Dec. 23 issue of
New England Journal of Medicine.
The company has applied to the U.S. Food and Drug Administration
for drug approval and expects to complete the application process
in the first quarter of 2011, said Christina Trank, associate
director of public affairs for Bristol-Myers Squibb, headquartered
in New York City.
Sanofi-Aventis makes the older drug, enoxaparin (Lovenox).
"The apixaban was superior to enoxaparin, including the total number of patients with thromboembolism and major embolism," said lead study author Dr. Michael Rud Lassen, a spine surgeon and clinical researcher at Horsholm Hospital at the University of Copenhagen.
Deep vein thrombosis is one of the most common complications
after lower extremity surgery, including hip and knee replacement,
explained Dr. Richard Stein, a professor of cardiology at New York
University School of Medicine and a spokesman for the American
Clots can form in the veins of the legs, leading to chronic
swelling, and a piece of the clot can break off and travel to the
lungs, forming a pulmonary embolism, which can be fatal.
After hip replacement, patients typically receive (warfarin)
Coumadin, a blood thinner that inhibits clotting. But Coumadin
takes a day or more to kick in, so patients usually are immediately
put on enoxaparin, Stein added.
There are several drawbacks to that strategy. Enoxaparin is
delivered by injection, whereas apixaban can be taken in oral
Coumadin can be somewhat unpredictable and patients taking it
have to be monitored, Stein said.
"It often is difficult to find the right dosage. Sometimes we overshoot and patients are at risk of bleeding, and sometimes we undershoot and they are at risk of getting the clot in their vein," Stein said.
The new drug seemed to reduce clots by nearly half and resulted
in slightly fewer problems with bleeding at the surgical site,
"This is an important article," Stein said. "They showed a reduction in bleeding and a reduction in major and minor complications, including deep vein thrombosis, non-fatal pulmonary embolism or cardiac death, which usually means fatal pulmonary embolism. They showed those risks were reduced substantially in the group taking the apixaban compared to the enoxaparin group."
Apixaban is also being studied for use after knee replacement
surgery and for patients with atrial fibrillation, among other
conditions. In addition to the hip replacement study, there are
eight other completed or ongoing Phase III clinical trials
involving the drug, Trank said.
Apixaban is one of several drugs under development that work by
inhibiting factor Xa in the blood, according to an accompanying
editorial that predicts a huge impact if the drug is
Bristol-Myers Squibb declined to provide information about the
cost of the drug.
U.S. National Heart, Lung, and Blood Institute has
more on deep vein thrombosis.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
Copyright © EBSCO Publishing. All rights reserved.