Heart drug may cause bleeding

Study finds that Plavix can be dangerous for people taking it to prevent 1st heart attack


ATLANTA --Cardiologists are re-evaluating how they prescribe Plavix, a popular heart medication, after a major clinical study found that the drug may cause dangerous bleeding in patients who take it along with aspirin to ward off a first heart attack.

The announcement of the results of the study, which will be published in The New England Journal of Medicine this week, created a buzz at the annual meeting of the American College of Cardiology meeting, one of the world's largest gatherings of cardiologists, partly because of the implications for patients and partly because the results might have been disclosed to a financial analyst before their release yesterday.

A Bloomberg News article Thursday about continuing studies of the drug quoted financial analysts as expecting the study to find that the drug was of no help in preventing a first heart attack among at-risk patients.

That article so concerned the conference organizer, the American College of Cardiology, that it almost refused to publicly release the study, said Amy Murphy, a spokeswoman for the organization.

Whether the study results had been disclosed before yesterday or whether the financial analysts merely predicted the outcome was not clear.

But what was clear was that the study could have a significant impact on use of the drug, which is marketed in the United States as Plavix. It could also affect the drug's distributors, Sanofi-Aventis, a French drug manufacturer, and Bristol-Myers Squibb of New York. Plavix is Sanofi-Aventis' top-selling drug.

In 2002, the American Heart Association and the American College of Cardiology issued a joint statement endorsing the short-term use of Plavix as part of the treatment regimen for patients who had been evaluated in the emergency room as having had a mild heart attack or who were at high risk of having a heart attack.

Plavix seemed to work so well that many physicians began prescribing it, along with standard low-dose aspirin therapy, to patients who had risk factors for heart disease but who had never had a heart attack or stroke.

"There's been an extrapolation of these data results to a larger and larger patient population," said Matthew Wolff, chief of cardiology at the University of Wisconsin, Madison. "This is being given to patients who cardiologists think in a very subjective way are at substantially increased risk without any formal guidance as to what substantially increased risk is."

The trial results released yesterday studied use of Plavix in a population of more than 15,000 patients who fell into both groups - those who seemed to be well on their way to a heart attack or stroke and those who had experienced a cardiovascular event like a stroke, heart attack or a blocked artery in a leg.

In patients in the first category, Plavix offered no benefit over standard low-dose aspirin therapy, and it significantly increased the risk of internal bleeding, a complication that can be life-threatening, the study found.

When combined with aspirin, Plavix may offer a small benefit to the second category of patients, those who have suffered a heart attack or stroke. But critics say even that benefit - a 1 percent reduction in the risk of heart attack, stroke or death from cardiovascular disease - may not be borne out after the study's information has been further parsed.

"When the dust settles," Wolff said, "people are going to want to look at the magnitude of the overall benefit, which was relatively modest, and they're going to look at the cost of adding clopidogrel to aspirin in a world where there are a lot of drugs we can use to prevent disease."

Plavix, which costs as much as $4 a pill, generated more than $6 billion last year in annual sales worldwide for Sanofi-Aventis and Bristol-Myers Squibb. It is second only to Lipitor, which generated about $12 billion in sales last year.

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