Schering-Plough Announces Results of the Early...( Early Use of INTEGRILIN(R) Investigat...),Health

Early Use of INTEGRILIN(R) Investigational Dosing is Not Superior to Delayed Provisional Use in Patients with High-Risk Acute Coronary Syndrome, Study Finds

KENILWORTH, N.J., March 30 /PRNewswire-FirstCall/ -- In a study presented today at the 58th annual Scientific Sessions of the American College of Cardiology and simultaneously published by The New England Journal of Medicine, researchers reported that a strategy using an upstream, investigational dose of INTEGRILIN(R) (eptifibatide) routinely in patients with Acute Coronary Syndrome (ACS), at least 12 hours prior to angiography, failed to achieve either the primary or secondary endpoints of the trial. Significantly higher rates of bleeding and transfusions also were reported.

"These results do not support the upstream use of double-bolus plus infusion eptifibatide as a routine course of treatment in ACS," said Enrico Veltri, M.D., group vice president of global clinical research, cardiovascular and metabolic disease, Schering-Plough Research Institute. "However, the results do not change what other studies have previously reported: that eptifibatide remains an integral component of therapy for appropriate patients undergoing PCI."

L. Kristin Newby, MD, associate professor of medicine at Duke Clinical Research Institute, presented the results of the nearly 9,500-patient Early Glycoprotein IIb-IIIa Inhibition in Non-ST-Segment Elevation Acute Coronary Syndrome (EARLY ACS) study, which was designed to determine whether routine early use of eptifibatide would result in improved cardiovascular outcomes for patients with ACS compared to delayed provisional use. The primary efficacy endpoint was a composite of death, (re)infarction (MI), recurrent ischemia requiring urgent revascularization, or thrombotic bailout through 96 hours. The secondary endpoint was death or (re)MI at 30 days. Safety endpoints included bleeding and transfusions through 120 hours.