INTEGRILIN Stent Study Halted Early Due to Positive Results
BUSINESS WIRE - February 04, 2000 08:18
SOUTH SAN FRANCISCO, Calif., Feb 4, 2000 (BW HealthWire) -- COR Therapeutics, Inc. (Nasdaq:CORR) and Schering-Plough Corporation (NYSE:SGP) announced today that enrollment in the ESPRIT study of INTEGRILIN (R) (eptifibatide) Injection in 2,400 patients undergoing coronary intervention with stenting has been halted early after an almost 50 percent reduction in death or heart attack at 30 days at an interim analysis.
The results of the interim analysis were reviewed by an independent Data Safety Monitoring Committee (DSMC) which determined that the study should be stopped due to the highly significant reduction in the combined incidence of death or myocardial infarction with INTEGRILIN compared with placebo over 30 days (P=0.0011) following a stenting procedure. A significant reduction was seen as early as 48 hours (P=0.0017) in the interim analysis of 1,758 patients.
Consistent with the DSMC's charter, the committee also assessed the safety profile of INTEGRILIN and concluded that there was no difference in the incidence of severe bleeding events between INTEGRILIN and placebo. There was a modest increase in the incidence of moderate bleeding with INTEGRILIN.
"Given the dramatic reduction in clinically serious outcomes achieved, the committee unanimously agreed that the placebo patients should not be denied access to this type of therapy," stated Robert M. Califf, MD, Associate Vice Chancellor for Clinical Research at Duke University Medical Center and Director of the Duke Clinical Research Institute, the coordinating center for the study conducted at over 90 sites in the United States and Canada. "The results of this study reinforce our conviction that GP IIb-IIIa inhibitors should be the standard of care for patients undergoing intracoronary stenting. We now have convincing evidence that INTEGRILIN represents a highly efficacious therapy for these vulnerable patients." |
