"Taking Plavix With Aspirin Proves Risky", Houston Chronicle, March 12,
2006,
Link: http://www.chron.com/disp/story.mpl/ap/health/3718610.html

People taking the blood thinner Plavix on top of aspirin to try to
prevent heart attacks, as many doctors recommend, now have good reason
to stop.

The drug combination not only didn't help most people in a newly
released study, but it unexpectedly almost doubled the risk of death,
heart attack or stroke for those with no clogged arteries but with
worrisome conditions like high blood pressure and high cholesterol.

"They actually were harmed," said Dr. Eric Topol. "This was a trial to
determine the boundaries of benefit, and it did. You don't use this
drug for patients without coronary artery disease."

He and Dr. Deepak Bhatt of the Cleveland Clinic led the study, which
involved 15,603 people in 32 countries. Topol has since left the clinic
and is at Case Western Reserve University in Cleveland.

Results were reported Sunday at an American College of Cardiology
conference whose organizers issued an "expression of concern" saying
the drug's maker, Sanofi-Aventis SA, told some stock analysts the
results of the study in advance, in violation of the conference's
embargo policies.

However, Sanofi spokesman Michel Joly denied the claim Sunday, saying
the company provided no results in advance.

Aspirin's ability to prevent heart attacks in men is legendary but it
does little for their risk of stroke. In women, aspirin wards off
strokes but only reduces heart attack risk in those 65 or older. Adding
Plavix to aspirin for people being treated for a heart attack cuts
their risk of a second one or death.

For these reasons, doctors thought the drug combination might prevent
"heart attacks waiting to happen" in people with very clogged arteries
or lots of risk factors like heavy smoking, diabetes and high
cholesterol.

They gave everyone in the study low daily doses of aspirin plus Plavix
or a dummy pill and looked at how they fared more than two years later.

Adding Plavix made little difference for the group as a whole except
for slightly reducing hospitalizations. But for the 20 percent with no
signs of heart disease, the drug combination proved dangerous.
Heart-related deaths almost doubled, from 2.2 percent of those taking
only aspirin to 3.9 percent of those who added Plavix.

The only people even modestly helped by adding Plavix were those with
established heart disease. Their risk of heart attack, stroke or death
was about 7 percent versus 8 percent for those taking aspirin alone.

Specialists said this was not enough to justify recommending the drug
in light of the overall findings of no benefit.

The cost and risks of Plavix don't justify expanding its use for
prevention, Dr. Marc Pfeffer of Brigham and Women's Hospital in Boston
and Dr. John Jarcho of the New England Journal of Medicine write in an
editorial in the journal, which will be published along with the study
results in the April 20 issue.

"Plavix should not be used for prevention," said Dr. Elizabeth Nabel,
director of the National Heart, Lung and Blood Institute. "Aspirin
alone is sufficient."

The study was paid for by Sanofi and Bristol-Myers Squibb, which sell
Plavix in the United States for about $4 a pill. Outside the U.S. the
drug is sold as Iscover. Many of the researchers have ties to the
companies or others that make heart drugs.

Also at the conference, the third study in roughly a year confirmed
that a different strategy to prevent heart attacks _ folic acid and
vitamin B supplements _ doesn't work.

These lower homocysteine, a blood substance that can make arteries
stiffen and clog.

Dr. Eva Lonn of McMaster University in Hamilton, Ontario, and
colleagues gave 5,522 people with clogged arteries or diabetes these
vitamins or phony pills for five years. Homocysteine dropped in people
given the supplements, but not the risk of heart attack or death.
Vitamin takers suffered slightly fewer strokes than the others, but
they also were more likely to be hospitalized for chest pains.

Results were released by the New England Journal, which will publish
them in print later.