- The Washington Times - Monday, March 13, 2006

ATLANTA (AP) — People taking the blood thinner Plavix in addition to aspirin to try to prevent heart attacks, as many doctors recommend, 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 such as high blood pressure and high cholesterol.

“They actually were harmed,” Dr. Eric Topol said. “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 persons in 32 countries. Dr. Topol has since left the clinic and is at Case Western Reserve University in Cleveland.

Results were reported yesterday 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-Aventis spokesman Michel Joly denied the claim, saying the company provided no results in advance.

Aspirin’s ability to prevent heart attacks in men is well-established, 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 several risk factors such as heavy smoking, diabetes and high cholesterol.

They gave everyone in the study low daily doses of aspirin plus Plavix or a dummy pill and studied 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, compared with 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 and Dr. John Jarcho of Brigham and Women’s Hospital in Boston 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.”

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