SUNDAY, March 10 (HealthDay News) -- In the search for better
medicines to safely help heart patients, clinical trials testing
three new drugs appear to offer some promise.
Two of the drugs, cangrelor and inclacumab, might improve
outcomes for patients undergoing cardiac interventions such as
angioplasty or stenting, while a third drug, Inspra, seems to lower
heart patients' odds for death and heart failure following a heart
All three trials were funded by the respective drugs' makers,
and all three were presented Sunday at the annual meeting of the
American College of Cardiology (ACC) in San Francisco.
In the first trial, researchers compared an as-yet unapproved
blood thinner called cangrelor against the current standard
medication, Plavix (clopidogrel), for patients who have recently
had a stent implanted in an artery to help improve blood flow.
According to the ACC, more than 600,000 coronary artery stent
procedures are conducted in the United States each year, but
doctors have long sought safer alternatives to Plavix to help
prevent clots. Plavix comes with one big drawback for patients
rushed to the hospital with suspected heart attack: It is taken in
pill form, and its anti-clotting effects (with accompanying
bleeding risk) may not wear off for up to a week.
That means that pre-treating a new patient with Plavix can
trigger long delays in needed heart surgery, as the patient waits
for the bleeding risk to subside.
Cangrelor may help get around that issue. Even though it is
delivered intravenously and begins acting quickly, its
anti-clotting effects also fade quickly -- within an hour -- should
any bleeding complications occur, the study authors said.
So, doctors might feel free to give heart patients cangrelor
upon admittance to the hospital and then send them immediately for
angioplasty -- a minimally invasive procedure to reopen clogged
vessels -- or stenting, if needed.
In the trial, which was funded by cangrelor's maker, New
Jersey-based The Medicines Company, researchers compared short-term
outcomes for 11,000 patients who underwent stent placement at one
of 153 centers around the world.
Some of the patients got cangrelor, while others got Plavix. The
study was also published online Sunday in
The New England Journal of Medicine.
The research team reported that cangrelor reduced by 22 percent
the odds of a patient dying, having a heart attack or having a clot
develop in the stented vessel within two days of the procedure,
compared to patients who took Plavix. Safety profiles were similar:
Severe bleeding at 48 hours after the stenting procedure occurred
in 0.16 percent of those on cangrelor and 0.11 percent of those
Commenting at a press conference on Sunday, Dr. Cindy Grines, a
cardiologist at Detroit Medical Center, said that if cangrelor
receives U.S. Food and Drug Administration approval it could have a
"huge impact" for heart patients.
The new study "shows that we do not necessarily have to
pre-treat these patients, but once they get to the lab we can give
them a very rapidly acting medication with rapid-onset action and
rapid offset," she said.
There's one caveat, however: cost. Lead researcher Dr. Deepak
Bhatta, chief of cardiology at Brigham and Women's Hospital in
Boston, told reporters that cangrelor's price has not yet been set,
but it likely will carry a much higher price tag than Plavix. But,
he believes the cost of the drug would be offset by savings gained
as patients avoid lengthy pre-surgery hospital stays, waiting for
the effects of Plavix to wear off.
A second study focused on the drug eplerenone, marketed by
Pfizer as Inspra. The drug is currently FDA-approved to help lower
high blood pressure and to ward off heart failure after heart
attack. In the new Pfizer-funded trial, slightly more than 1,000
patients who had had a heart attack caused by complete blockage of
an artery took either Inspra or a placebo in addition to standard
Patients were followed for an average of a bit more than 10
months. Researchers led by Dr. Gilles Montalescot of the
Pitie-Salpetriere Hospital in Paris reported that those taking
Inspra were 38 percent less likely than those on a placebo to have
outcomes such as death by cardiovascular causes, rehospitalization
due to heart failure, irregular heart rhythms or other indicators
of heart failure.
Commenting on the results at a news conference, Dr. Miguel
Quinones, chair of cardiology at Methodist DeBakey Heart and
Vascular Center in Houston, said the study showed a "striking"
short-term benefit for patients, but it's unclear if it would be
sustained over time. Use of Inspra could be "a game-changer if we
could demonstrate three to five years later that we have
significantly improved outcomes," he said.
A third and smaller trial, published simultaneously online in
Journal of the American College of Cardiology, looked at
another still-unapproved drug, the anti-inflammatory agent
inclacumab, for use in patients undergoing angioplasty.
The ACC noted that more than 1 million Americans each year
undergo angioplasty. But angioplasty can also trigger damage to
heart tissues, and it was thought that the new drug might help
minimize that risk.
In the study, which involved 322 patients with a common form of
heart attack, participants got either various doses of inclacumab
or a placebo about an hour before their angioplasty.
The research team assessed changes in levels of troponin I -- a
protein found in the blood that indicates heart damage -- as a
means of telling whether the drug was effective or not.
The researchers reported that 24 hours after the procedure,
patients who had gotten the highest dose of inclacumab saw their
troponin I levels drop by more than 24 percent compared to those on
a placebo -- indicating less heart tissue damage. Levels of another
marker of heart tissue damage, called CK-MB, fell by more than 17
percent over 24 hours compared to placebo, the team added.
There was also "no bad signal [from the data] in terms of
increased rates of bleeding or infection" with the use of
inclacumab, study author Dr. Jean Claude Tardif, director of the
Research Center at the Montreal Heart Institute, told
One expert agreed, but said more study is needed. "This looks to
be very promising, [and] I hope we get to see this continuing in
larger trials," Dr. Neal Kleiman, medical director of the Cardiac
Catheterization Laboratories at the Methodist DeBakey Heart and
Vascular Center in Houston, said at the press briefing.
Tardif said that such a trial is being planned. The current
study was funded by the drug's developer, Hoffman-La Roche Ltd.
Findings from studies that have only been presented at medical
meetings, such as the Inspra trial, are typically considered
preliminary until published in a peer-reviewed journal.
Find out more about drugs that work to fight heart failure at
American Heart Association.
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