Heart attack and stroke patients are getting access to a new blood thinner that may be slightly better than aspirin in lowering their risk of repeat attacks.
But before prescribing it, doctors must decide whether clopidogrel, approved by the Food and Drug Administration on Monday, provides enough extra benefit to justify having their patients pay more than the pennies-a-day costs of aspirin.The manufacturers, Sanofi Inc. and Bristol-Myers Squibb, declined to disclose a price, saying they would announce it when clopidogrel begins selling, by prescription, early next year. It will be sold under the brand name Plavix.
New drugs typically are priced higher than older competitors, as companies try to recover the millions of research dollars that went into the medicines' development.
Thousands of Americans take half an aspirin or a baby aspirin every day to help prevent the blood clots that lead to heart attacks and strokes.
While aspirin works well, companies are racing to develop even better "platelet inhibitors," clot-preventing drugs that would be stronger and not come with aspirin's side effect, a tendency to cause stomach ulcers or bleeding.
In the biggest study of a new drug ever performed, Sanofi and Bristol-Myers tested clopidogrel on 19,000 patients in 16 countries. Over three years, clopidogrel reduced the risk of a repeat heart attack or stroke by about one-third, while aspirin lowered the risk by about one-quarter.
Because of the small difference, Sanofi and Bristol-Myers will not be allowed to advertise the drug as better than aspirin.
The main side effects of clopidogrel are rash and diarrhea - and patients in the study suffered slightly fewer ulcer-related side effects than aspirin users.
The drug is intended for anyone who recently suffered a heart attack or stroke or who currently has peripheral artery disease.