MUNICH (Reuters Health) - An investigational platelet inhibitor, prasugrel, demonstrated “promising” results in patients undergoing percutaneous interventions, but the drug failed to demonstrate a significant benefit over clopidogrel, according to results of a trial presented here at the European Society of Cardiology Congress 2004.
The drug, formerly known as CS-747, was associated with fewer coronary events than clopidogrel but the difference failed to reach statistical significance, said lead researcher Dr. Elliott Antman of the Harvard Medical School and Brigham and Women’s Hospital, Boston, Massachusetts.
The trial (known as JUMBO - TIMI 26) enrolled patients undergoing elective or urgent PCI. The event rate in the 649 patients randomized to prasugrel was 7.2% while the rate was 9.4% among patients randomized to clopidogrel, which is the standard of care.
Rates of myocardial infarction within 30 days of the procedure were 7.9% among those being treated with clopidogrel and 5.7% in the prasugrel group, Dr. Antman said, again noting the difference did not reach statistical significance.
Prasugrel appeared to be most effective at the highest dose -- 20 mg -- he said, but this was also associated with slight increases in bleeding events. Thus, only an intermediate 10 mg dose will be studied in a planned phase III study. Dr. Antman said the pivotal study, which will attempt to recruit 13,000 patients, is slated to begin in the fall.
Dr. Antman said that prasugrel was being developed as a drug that might be more efficacious than clopidogrel or might be used among patients who develop resistance to clopidogrel.
The study was funded by Eli Lilly and Company, which is developing the drug.
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