A Lilly Drug Logs Success And Risks In Heart Trial
[2008-4-9]
An experimental anticlotting drug from Eli Lilly reduced heart attacks in patients with heart disease by 24 percent compared with Plavix, the current standard treatment, according to a report released Sunday in The New England Journal of Medicine.
The experimental treatment also increased the risk of severe bleeding compared with Plavix, and quadrupled the risk of fatal bleeding, though the risk was still relatively small.
Still, Lilly and Daiichi Sankyo, the drug's co-developer, said they were pleased with the trial results. They noted that patients taking prasugrel, the new drug, reduced their overall cardiovascular risk by 13 percent even given the extra bleeding.
The companies said they planned to apply as early as the end of 2007 to the Food and Drug Administration for approval. If the F.D.A. approves the drug, it could be on the market by the end of 2008.
Both Plavix -- the world's second-best selling drug after Lipitor -- and prasugrel work in the same way, by preventing platelets in the blood from forming clots. But prasugrel is more potent, according to the results of the trial, which involved 13,000 patients who had heart disease and were receiving angioplasty.
The trial's results are promising and could clear the way for prasugrel to gain regulatory approval, according to Dr. Steven Nissen, the chairman of cardiovascular medicine at the Cleveland Clinic, who said he had been a consultant to Lilly on other drugs but not on prasugrel.
''There is a safety price to be paid,'' Dr. Nissen said, ''but I think for the majority of our patients, the benefits look like they're going to exceed the increased risk.''
But Dr. Tim Anderson, a former emergency room doctor who is now a drug industry analyst for Sanford C. Bernstein & Company, said he thought that regulators and doctors would be skeptical of prasugrel.
''Prasugrel might get approved, but I see it as more of a niche-type product,'' he said. ''Better efficacy and higher bleeding, including fatal bleeding -- it's a question mark, a serious question mark, both regulatory and commercial.''
The experimental treatment also increased the risk of severe bleeding compared with Plavix, and quadrupled the risk of fatal bleeding, though the risk was still relatively small.
Still, Lilly and Daiichi Sankyo, the drug's co-developer, said they were pleased with the trial results. They noted that patients taking prasugrel, the new drug, reduced their overall cardiovascular risk by 13 percent even given the extra bleeding.
The companies said they planned to apply as early as the end of 2007 to the Food and Drug Administration for approval. If the F.D.A. approves the drug, it could be on the market by the end of 2008.
Both Plavix -- the world's second-best selling drug after Lipitor -- and prasugrel work in the same way, by preventing platelets in the blood from forming clots. But prasugrel is more potent, according to the results of the trial, which involved 13,000 patients who had heart disease and were receiving angioplasty.
The trial's results are promising and could clear the way for prasugrel to gain regulatory approval, according to Dr. Steven Nissen, the chairman of cardiovascular medicine at the Cleveland Clinic, who said he had been a consultant to Lilly on other drugs but not on prasugrel.
''There is a safety price to be paid,'' Dr. Nissen said, ''but I think for the majority of our patients, the benefits look like they're going to exceed the increased risk.''
But Dr. Tim Anderson, a former emergency room doctor who is now a drug industry analyst for Sanford C. Bernstein & Company, said he thought that regulators and doctors would be skeptical of prasugrel.
''Prasugrel might get approved, but I see it as more of a niche-type product,'' he said. ''Better efficacy and higher bleeding, including fatal bleeding -- it's a question mark, a serious question mark, both regulatory and commercial.''
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