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Study Backs Heart Attack Drug

Associated Press

By DANIEL Q. HANEY AP Medical Editor

Monday, March 19, 2001

ORLANDO, Fla. (AP) - A blood thinner already used after angioplasty has been shown to be a highly effective treatment for people with ominous chest pain or mild heart attacks, and could potentially prevent 100,000 heart emergencies a year in the United States.

A major study released Monday found that the drug, called Plavix, reduced the risk of death, strokes and new heart attacks in these people by 20 percent, making it probably the most significant advance in their treatment since the introduction of aspirin.

``This is a breakthrough,'' said Dr. Valentin Fuster of Mount Sinai School of Medicine in New York. ``It will change the practice of medicine.''

Some 2 million Americans are hospitalized with mild heart attacks and bad chest pain annually. Experts said the drug's impact will be even greater if it becomes routine treatment for the additional 1 million Americans who have full-blown heart attacks.

``Everyone will be put on this,'' said Dr. Christopher Cannon of Brigham and Women's Hospital in Boston. ``It's relatively cheap and has monster benefits. This is what we have all been waiting for.''

Heart attack patients are already routinely sent home with aspirin, beta blockers, ACE inhibitors and cholesterol-lowering drugs.

Currently, Plavix, which was introduced in 1998, is given primarily to prevent dangerous blood clots after balloon angioplasty. But doctors say it will soon become a regular pill for many more heart patients.

The study, which was directed by Dr. Salim Yusuf of McMaster University in Hamilton, Ontario, was presented at a meeting in Orlando of the American College of Cardiology. The study was financed by Plavix's makers, Sanofi-Synthelabo and Bristol-Myers Squibb.

The study was conducted on 12,562 patients at 482 hospitals in 28 countries. All victims had what doctors call acute coronary syndrome. This is either mild heart attacks - known technically as non-Q-wave attacks because of their appearance on electrocardiograms - or unstable angina, which is chest pain that is especially severe or unpredictable.

All patients got their standard treatments, including aspirin, which has a similar effect as Plavix on the clotting cells called platelets. They were randomly assigned to get either daily Plavix or dummy pills within a day of their symptoms and stayed on the drug for periods ranging from three months to a year.

Doctors began to notice a benefit of the drug within the first two hours of treatment. They calculated that after a year, 9.3 percent of patients on Plavix had suffered a stroke, a new heart attack or died of cardiovascular disease, compared with 11.5 percent of those getting standard treatment.

The only important side effect was bleeding, which Plavix triggers about as often as aspirin does. The average patient follow-up was nine months.

The study suggests that Plavix could prevent 28 major life-threatening events for every 1,000 patients treated over nine months, Yusuf said. Six patients per 1,000 would need a transfusion for bleeding.

``It's a very exciting result on efficacy and a reassuring result on safety,'' Yusuf said.

If given only to patients with acute coronary syndrome, it will prevent between 50,000 and 100,000 new heart attacks, strokes and cardiovascular deaths in the United States each year, Yusuf estimated. Worldwide it could prevent 250,000 to 500,000 of these if used on just one-fifth of all patients who might benefit.

Plavix has also been linked to thrombotic thrombocytopenic purpura, or TTP, a dangerous and exceedingly rare form of anemia. Experts estimate that it may occur in 4 of each 1 million patients treated with Plavix, and no cases were seen in this study.

Plavix typically costs about $3 a day. Dr. Robert Califf of Duke University estimated that adding Plavix to the list of drugs given to heart-attack patients will increase their daily drug bill to between $8 to $10.

A study is under way on 30,000 people in China to see if adding Plavix truly improves the outcome of full-blown heart attacks. It is also being tested on people with heart rhythm abnormalities called atrial fibrillation as a safer alternative for the drug warfarin.

On the Net:

Cardiology college: http://www.acc.org

CDC heart disease site: http://www.cdc.gov/nccdphp/cvd

Copyright 2001 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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