Big question over new blood-clot buster drug Prasugrel

Nov 5 2007

A big question mark now exists over a new and experimental anti-blood clotting drug.

New research has revealed that the drug Prasugrel produced by drug company Eli Lilly increases the risk of serious bleeding when compared to the standard therapy.

A study on the drugs use in 13,600-patients has found that though Prasugrel proved to be impressively efficient it also increased the risk of serious bleeding by 32 percent in some patients.

The study compared the drug with Plavix which is produced by Bristol-Myers Squibb, in heart patients ranging from those with severe chest pain to heart attacks.

Both drugs work by keeping platelets from forming blood clots that can block off a major artery, thus preventing heart attacks and Prasugrel is far more powerful in that respect.

Analysts believe the news will deter doctors from prescribing Prasugrel because of the increased risk of bleeding but heart experts say the reduction seen in death from cardiovascular events (20% more than rival Plavix) outweighs deaths by bleeding.

They say most of the bleeding deaths occurred in patients in high-risk groups, such as those who had strokes or were low in body weight and 80 percent of patients did not fall into these groups and were at considerably lower risk of serious bleeding.

Eli Lilly says it can identify which patients are most likely to get a benefit from the medicine but it is now unclear whether the U.S. Food and Drug Administration will approve the new drug.

Dr. Elliott Antman a cardiologist at Harvard Medical School who led the study, says he believes Prasugrel is an approvable drug.

Antman says Aspirin reduced cardiovascular events 20% at a cost of more bleeding; Plavix, on top of aspirin, reduced events another 20%. Prasugrel adds a similar benefit to these previous leaps.

The Prasugrel data was released at the annual scientific meeting of the American Heart Association and is published in the New England Journal of Medicine.