Look at this Plavix Rival

Prasugrel outperforms Plavix in study, but has higher risk of bleeding.

"An experimental anticlotting drug from Eli Lilly reduced heart attacks in patients with heart disease by 24 percent compared with Plavix (clopidogrel bisulfate), the current standard treatment," according to study results to be published in the Nov. 15 issue of the New England Journal of Medicine. However, the new treatment, prasugrel, "also increased the risk of severe bleeding compared with Plavix, and quadrupled the risk of fatal bleeding, though the risk was still relatively small."

Plavix and prasugrel "work in the same way, by preventing platelets in the blood from forming clots. But prasugrel is more potent," study results indicate.If the FDA approves the drug, it could be on the market by the end of 2008."

"A three-year study into the new medication found that patients already at a high risk of bleeding could be harmed by taking" it. In addition, the drug's bleeding risk could be fatal in some trial participants, "typically...individuals with a history of strokes, and the elderly."

Dr. Elliott M. Antman, a professor of medicine at Harvard Medical School and colleagues, "randomly chose 13,608 patients at 707 sites in 30 countries," who were given "prasugrel (60 milligrams as a one-time 'loading' dose, followed by a 10-milligram maintenance dose) or Plavix (300 milligrams initially, followed by a daily 75-milligram maintenance dose) for up to 15 months following angioplasty and stenting to open blocked arteries."

During the study, "[o]nly 9.9 percent of participants taking prasugrel died from cardiovascular causes, compared with 12.1 percent of patients taking Plavix, a 19 percent reduction."

Additionally, "Prasugrel was...associated with a lower incidence of stent thrombosis, revascularization and heart attack." However, "the incidence of major bleeding was significantly higher with prasugrel -- 2.4 percent vs. 1.8 percent of patients on Plavix."

Patients like those who experienced bleeding problems during the trial would make up roughly "20 percent of the total population." Dr. Antman pointed out, "For the remaining 80 percent of the patients, which I would say represented eight of 10 patients undergoing stenting, the drug works very well."

Furthermore, among diabetics, who are considered a group at high risk of bleeding complications, "there was no excess bleeding, and a 30 percent reduction in [myocardial infarctions] compared with" Plavix. Roughly "99 percent of patients had percutaneous interventions at the time of [trial] randomization, 94 percent of them with at least one coronary stent, and 47 percent with a drug-eluting stent."

"Several leading cardiologists said they believe the results are strong enough for Lilly to gain...[FDA] approval to market the drug, in part because the overall benefit in the study favored prasugrel over Plavix, the current standard of care." Prasurgel "is intended to treat patients on the verge of a heart attack, and it marks" Eli Lilly's first attempt "to break into the blockbuster heart-drug arena."

Some physicians are optimistic about the drug's future," with many saying 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." Dr. Steven Nissen, of the Cleveland Clinic, who is also "a frequent government adviser," added, "I'm encouraged by the results," and expects that "prasugrel should win Food and Drug Administration approval because it so dramatically cuts non-fatal heart attacks."

"Doctors can sort out who might benefit most from prasugrel, 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."

"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." Should prasugrel gain FDA approval, physicians could prescribe it as frequently as Plavix, if not more often.