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Experimental Heart Drug Beats Plavix in Trials

Posted on: Monday, 5 November 2007, 06:00 CST

By Steve Sternberg

ORLANDO -- A potent new blood thinner trumped one of the nation's biggest-selling drugs, Plavix, in a major test of the drugs' power to prevent deadly blood clots in patients whose clogged arteries must be cleared using angioplasty, researchers said Sunday.

But the experimental drug, prasugrel (PRASS-uh-grell), caused more severe bleeding than Plavix, especially in patients who are elderly and frail and who have had strokes or fleeting strokelike episodes.

"We have to weigh the benefits and risks as we do with every medication. The bottom line is that this is an important advance," lead investigator Elliott Antman of Brigham and Women's Hospital in Boston told an American Heart Association meeting.

The report was also published in the New England Journal of Medicine.

For every 1,000 patients treated, Antman says, the new drug prevented 23 heart attacks and caused six major episodes of bleeding. He says the best way to prevent bleeding is by not giving the drug to patients in the highest-risk group.

"These are compelling results," says Sidney Smith of the University of North Carolina-Chapel Hill, chairman of the American Heart Association and American College of Cardiology task force on practice guidelines.

J. Anthony Ware of Eli Lilly & Co., which sponsored the prasugrel study with Daiichi Sankyo Co. Ltd., says the drug's co-developers plan to file for government approval before the end of the year.

The most widely used anti-clotting medications, aspirin and Plavix, have become mainstays of medicine in an era in which about 650,000 people a year undergo angioplasty, according to AHA. But Plavix, costing about $4 a day, doesn't fully prevent clotting in about 25% of patients, doctors say.

The new research pitted prasugrel against Plavix in a study of 13,608 patients with severe blockages in their coronary arteries. More than 3,500 of the patients were at the hospital and in the throes of a major heart attack.

Overall, patients given prasugrel had 19% fewer heart-related deaths, non-fatal strokes and non-fatal heart attacks, but a 32% increase in the risk of major bleeding, the study shows. Prasugrel cut in half the number of potentially deadly blood clots that formed in stents, springlike devices used to prop arteries open.

Blood clots have become a major concern among patients given drug-coated stents, because the coating seems to promote clot formation. Some doctors now recommend those patients take Plavix indefinitely.

Antman says the new drug "showed clear benefit" in diabetics, cutting by 30% the number of serious cardiovascular events and strokes without any excess bleeding. (c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

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