ORLANDO, Fla. - A new blood thinner proved better than Plavix, one of the world's top-selling drugs, at preventing heart problems after procedures to open clogged arteries, doctors reported Sunday. But the new drug also raised the risk of serious bleeding.
People given the experimental drug, prasugrel, were nearly 20 percent less likely to suffer one of the problems in a combined measure - heart attack, stroke or heart-related death - than those given Plavix, a drug that millions of Americans take to prevent blood clots that cause these events.
However, for each heart-related death that prasugrel (PRASS-uh-grell) prevented, compared to Plavix, almost one additional bleeding death occurred.
'There is a price to pay' for greater effectiveness, Dr. Deepak Bhatt, a Cleveland Clinic cardiologist, wrote in an editorial accompanying the results, which were published online by The New England Journal of Medicine and presented at an American Heart Association conference in Florida.
Still, many doctors said that on balance, the new drug comes out ahead, and offers great promise as a more potent alternative to Plavix, which costs $4 a day and does not work for some patients.
'I'm encouraged by the results' and think prasugrel should win Food and Drug Administration approval because it so dramatically cuts non-fatal heart attacks, said the Cleveland Clinic's Dr. Steven Nissen, a frequent government adviser.
Doctors can sort out who might most benefit from it, such as diabetics, and who might face too much bleeding risk to use it, like the elderly, people who previously had strokes and those with kidney problems, he said. (The Cleveland doctors give to charity or the clinic the consulting and research fees they earn from drugmakers.)
Doctors also were waiting for prasugrel's makers to clarify why they stopped two small studies of it a week ago. They said it was due to dosing problems but did not explain.
Prasugrel is being developed by Indianapolis-based Eli Lilly and Co. and a Japanese firm, Daiichi Sankyo Co. It could be a hugely important drug, and the study has been one of the most-watched tests of a novel heart medication in recent years.
Like Plavix, prasugrel prevents blood components called platelets from sticking together and forming a clot. Anti-platelet drugs are advised for most people with stents - tiny mesh tubes that keep arteries open after balloon angioplasty, an artery-clearing procedure that more than a million Americans have each year.
Plavix, sold by Sanofi-Aventis SA and Bristol-Myers Squibb Co., has been the most effective drug of this type. More than 70 million people have taken it since it went on sale a decade ago.
Plavix had 18.6 million prescriptions and nearly $3 billion in U.S. sales last year, according to IMS Health, a healthcare information firm. Worldwide sales were nearly $6 billion.
The study comparing it to prasugrel involved 13,608 patients from 30 countries and was led by Dr. Elliott Antman at Harvard Medical School and Brigham and Women's Hospital in Boston. Prasugrel's makers paid for the study; many of the researchers work or consult for them.