WEDNESDAY, Sept. 22 (HealthDay News) -- A blood-thinning drug
could help some patients with superficial-vein thrombosis avoid
more serious blood clots, a new study suggests. But experts
question whether the benefit is worth the drug's high price.
Superficial-vein thrombosis, or superficial phlebitis, is
characterized by blood clots in leg veins close to the skin. "This
clot occurs in 90 percent of cases of varicose veins and is painful
and visible for the patient," said the study's lead author, Dr.
Herve Decousus, a researcher with University Hospital in
Saint-Etienne, France.
Many factors -- long flights, pregnancy or recent surgery, among
them -- can cause the condition. While serious complications of
superficial-vein clots are rare, people with the condition can be
at risk of developing deep-vein thrombosis, which is more serious
and potentially fatal. Some doctors treat the superficial clots
with blood-thinning medication or surgery; others don't treat them
at all.
In the new study, researchers treated the superficial clots with
Arixtra (fondaparinux), which is used to prevent and treat clots in
the deep veins of the legs and in the lungs (pulmonary embolism),
or a placebo. The pharmaceutical company GlaxoSmithKline, which
makes Arixtra, funded the study.
Researchers randomly assigned 3,002 patients to receive either
injections of 2.5 mg of Arixtra daily or a placebo for 45 days.
They monitored the patients for another 32 days.
The study findings appear in the Sept. 23 issue of
The New England Journal of Medicine.
The risk of developing deep-vein blood clots or clots in the
lungs was lower in those who took the drug: 0.2 percent in those
taking Arixtra vs. 1.3 percent in those getting the placebo.
The researchers also found that the risk of serious adverse
events was less in the Arixtra group (0.7 percent) compared with
the placebo group (1.1 percent). One patient in each group suffered
major bleeding, they said.
"This treatment is effective, safe and relatively simple," Decousus said.
However, the risk of death -- one in 1,000 -- was the same in
both groups. And overall, the researchers estimated that they'd
have to treat 88 people with the drug to prevent one case of a
deep-vein or lung blood clot.
Since the drug is safe, Decousus said, it's an acceptable
treatment. "There are many diseases with a low risk of mortality
which, nevertheless, require effective treatment to prevent
disabling complications and the need for more aggressive therapies
such as surgery."
But one American expert was more cautious. Dr. Julie Freischlag,
director of the department of surgery at Johns Hopkins School of
Medicine in Baltimore, said that it was rare that the clots would
pose a serious threat. The findings "didn't convince me to use this
in all patients. I've only seen a few clots go deeper," she
said.
And in an accompanying commentary in the journal, two American
doctors cautioned that the drug is expensive, costing $2,124 to
$7,380 in New York City for a once-daily, 45-day supply. They
recommended that government officials spend more time studying the
drug and its cost-effectiveness. Until there's a consensus, they
wrote, "it would be premature" to recommend the drug for this
use.
More information
For more about
superficial-vein thrombosis, visit the U.S. National Library of Medicine.