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Nor is Effient (prasugrel) any safer than Plavix (clopidogrel) when it comes to bleeding complications in patients with acute coronary syndrome who have not had revascularization procedures such as bypass surgery or stenting.
The findings are scheduled to be presented Sunday at the European Society of Cardiology annual meeting in Munich and simultaneously published online in the New England Journal of Medicine.
The study was funded by Eli Lilly and Co. and Daiichi Sankyo Co., which co-developed Effient.
Roughly 60 percent of patients with ACS undergo revascularization procedures to restore blood flow to the heart while the remaining 40 percent are managed by medications alone, the researchers said.
A previous trial of more than 13,000 ACS patients who were about to receive stents found that Effient was about 20 percent more effective than Plavix in preventing death, heart attacks and stroke. However, Effient also resulted in more cases of fatal bleeding.
This study was designed to look at a completely different group of ACS patients: those who did not undergo a revascularization procedure.
"This group of patients has never been exclusively studied before in a large-scale trial," said study author Dr. Matthew Roe, an associate professor of medicine at Duke University Medical Center in Durham, N.C.
Roe and other study authors reported financial ties with Eli Lilly, Daiichi Sankyo and other pharmaceutical companies.
For this study, 7,243 patients in 52 countries were randomized to receive 10 milligrams daily of Effient or 75 milligrams a day of Plavix. Both groups also took aspirin.
After an average follow-up of 17 months, 14 percent of patients receiving Effient died or had a heart attack or stroke, compared with 16 percent of those taking Plavix, not a statistically significant difference.
There was, however, some improvement in some health outcomes beyond the one-year mark in patients under the age of 75 taking Effient, the authors noted.
"There may be some patients who benefit for the longer term with platelet inhibitors," Roe said. "These patients that do not undergo revascularization may be fundamentally different from those who do [and] may need treatment longer. The exact reasons are not certain."
Plavix has the additional advantage of being inexpensive -- as little as about $35 for a month's supply since the drug went generic in May. Effient, on the other hand, can cost hundreds of dollars a month.
One expert noted that might make the difference when it comes to deciding which to prescribe for this group of patients.
"In the long run, it's going to come down to cost," said Dr. Christopher Cove, assistant director of the cardiac catheterization lab at the University of Rochester Medical Center. "Now that clopidogrel is generic, it's going to be tougher to prescribe a drug that's going to cost a lot more money without significant benefits."
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