>>SOUTH SAN FRANCISCO, Calif. & KENILWORTH, N.J.--(BUSINESS WIRE)-- Feb. 6, 2002--
COR Therapeutics, Inc. (NASDAQ: CORR - news) and Schering-Plough
Corporation (NYSE:SGP - news) announce publication of the
one-year results of the ESPRIT study
The Journal of the American Medical Association (JAMA) reported today that one year following a heart procedure, known as intracoronary stenting, patients who received INTEGRILIN® (eptifibatide) Injection in addition to traditional care continued to benefit from a significant reduction in the combined incidence of death or heart attack. The publication of these long-term outcomes has been much anticipated by interventional cardiologists who have already broadly adopted INTEGRILIN usage at time of intracoronary stenting. INTEGRILIN is currently the most-used agent in the class of antiplatelet agents, known as intravenous GP IIb-IIIa inhibitors.
The publication reported that the combined incidence of death or heart attack was significantly reduced from 12.4 percent with placebo to 8.0 percent with INTEGRILIN (P=0.0010). A consistency of benefit was reported regardless of patient age, weight, sex, clinical condition, or presence or absence of diabetes. Follow-up vital status information was available for 98.1 percent of all patients at 12 months.
``One of the most important findings from this analysis is that the incidence of death or heart attack at one year was reduced to similar levels with INTEGRILIN in both diabetic and non-diabetic patients,'' stated James E. Tcheng, MD, Associate Professor of Medicine at Duke University Medical Center in Durham, NC and Principal Investigator for the trial. ``Another key finding is that the benefits of INTEGRILIN continued to accrue over time. There were greater absolute differences in endpoint rates at 1 year than at 30 days in the composite of death or heart attack, and the composite of death, heart attack, or repeat revascularization procedures. Coupled with the salutary effects demonstrated in diabetic patients, our findings argue strongly for the use of INTEGRILIN in all classes of patients undergoing percutaneous coronary intervention to improve both short- and long-term outcomes.''
The incidence of death or heart attack at one year in diabetics was reduced from 13.4% with placebo to 7.8% with INTEGRILIN (P=0.05) and from 12.0% with placebo to 8.1% with INTEGRILIN in non-diabetic patients (P=0.01).
The ESPRIT (Enhanced Suppression of Platelet Receptor GP IIb-IIIa using INTEGRILIN Therapy) study was the first trial designed to assess the efficacy and safety of GP IIb-IIIa inhibitor therapy in patients undergoing non-urgent percutaneous coronary intervention (PCI) with the wide variety of intracoronary stents currently used in clinical practice.
On February 4, 2000, an independent Data Safety Monitoring Committee (DSMC) stopped enrollment early in ESPRIT after an interim analysis of 1,758 patients revealed a highly statistically significant reduction in the incidence of death or heart attack at 48 hours with INTEGRILIN as compared to placebo. Analysis of the entire cohort of 2,064 patients enrolled in ESPRIT at the time of study termination documented that the primary endpoint of death, heart attack, need for urgent target vessel revascularization, or need for thrombotic bail-out therapy at 48 hours was reduced with INTEGRILIN from 10.5 percent with placebo to 6.6 percent (P=0.0015). The combined incidence of death, heart attack, or need for urgent target vessel revascularization at 30 days was reduced from 10.4 percent with placebo to 6.8 percent with INTEGRILIN (P=0.0034). The combined incidence of death or heart attack was reduced from 11.5 percent with placebo to 7.4 percent with INTEGRILIN at 6 months (P=0.0015). Major bleeding, primarily at the site for PCI catheter placement, was increased from 0.4 percent to 1.3 percent.
Nearly 600,000 percutaneous coronary interventions are performed in the United States each year to restore blood flow through occluded arteries that supply oxygen to heart muscle. More than 60 percent of all PCI procedures employ the use of intracoronary stents, metal mesh structures that hold the artery open after the procedure. Although PCI and intracoronary stenting are generally successful at restoring blood flow and preventing the collapse of the artery, the deployment of the stent into the artery wall can result in the clumping of blood cells called platelets and the development of an intracoronary thrombus or blood clot. Because the thrombus can obstruct blood flow through the artery and thus deprive the heart muscle of oxygen supply, myocardial infarction (heart attack) or death can occur. Some patients may require urgent repeat intervention to reopen the artery. The vast majority of these thrombotic complications take place shortly following the PCI procedure.
INTEGRILIN helps prevent reocclusion of the stented artery by blocking certain receptors, known as GP IIb-IIIa, on platelets that are responsible for thrombus development. The effects of INTEGRILIN are exerted at the time of the PCI procedure when the patient is at highest risk.
About INTEGRILIN® (eptifibatide) Injection
INTEGRILIN is indicated for the treatment of patients with acute coronary syndrome (unstable angina and non-Q-wave myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention. It is also indicated in the United States for the treatment of patients at time of PCI, including in patients undergoing intracoronary stenting.
INTEGRILIN is contraindicated in patients with a history of bleeding diathesis, or evidence of abnormal bleeding within the previous 30 days; severe hypertension (systolic blood pressure greater than 200 mm Hg or diastolic blood pressure greater than 110 mm Hg) not adequately controlled on antihypertensive therapy; major surgery within the preceding six weeks; history of stroke within 30 days, or 0any history of hemorrhagic stroke; current or planned administration of another parenteral GP IIb-IIIa inhibitor; dependency on renal dialysis; or known hypersensitivity to any component of the product.
Bleeding is the most common complication encountered during INTEGRILIN therapy. The majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal and retroperitoneal bleeding were also seen more commonly with INTEGRILIN compared to placebo.
COR Therapeutics, Inc. and Schering-Plough Corporation are worldwide partners for INTEGRILIN. Both companies market and sell the drug in the United States. Schering-Plough markets INTEGRILIN outside the United States. COR has the right to co-promote INTEGRILIN in Europe and Canada at a later date.<<
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Cheers, Tuck |
