Thursday December 14, 7:51 pm Eastern Time
Press Release
INTEGRILIN -eptifibatide- Injection Reduces Major Ischemic Complications in Patients Undergoing Intracoronary Stent Implantation
First major pivotal study of an intravenous GP IIb-IIIa inhibitor in contemporary percutaneous coronary intervention published in The Lancet
SOUTH SAN FRANCISCO--(BW HealthWire)--Dec. 14, 2000-- COR Therapeutics, Inc. (Nasdaq: CORR - news) announced today the publication of the 48-hour and 30-day results from the ESPRIT study, which demonstrated statistically and clinically significant improvements in outcomes in patients receiving INTEGRILIN® during non-emergency percutaneous coronary intervention (PCI), in the December 16 issue of the medical journal, The Lancet.
The study showed that when INTEGRILIN was administered in addition to modern PCI techniques, which include the use of multiple intracoronary stents, even in small tortuous vessels, the combined incidence of death, myocardial infarction, need for urgent repeat intervention, or need for thrombotic bail-out therapy at 48 hours was reduced with INTEGRILIN from 10.5 % to 6.6 % when compared to placebo (P=0.0013). The key longer-term endpoint of the combined incidence of death, myocardial infarction, or need for urgent revascularization at 30 days was reduced from 10.5% with modern PCI techniques alone to 6.8% with INTEGRILIN (P=0.0034). ESPRIT allowed for bail out to INTEGRILIN in patients who initially received placebo if thrombotic complications arose; the authors note that without this provision the placebo event rate would likely have been higher.
Six-month data from ESPRIT continue to be collected. When the collection process is completed, the data will be locked and then unblinded. The results are expected to be released via a press release shortly after the data are unblinded.
Consistent with previous clinical trials of GP IIb-IIIa inhibitors, major bleeding, primarily at the site for PCI catheter placement, was increased from 0.4% to 1.3%. This represents the lowest major bleeding rate reported in any previously reported major trial of a GP IIb-IIIa inhibitor in PCI.
``These results demonstrate the need for the broad use of GP IIb-IIIa inhibitor therapy prior to the initiation of percutaneous coronary intervention, even with today's sophisticated procedural techniques,'' stated James E. Tcheng, MD, lead investigator for ESPRIT and Associate Professor of Medicine at Duke University Medical Center. ``Due to cost constraints in the past, many physicians limited their use of GP IIb-IIIa inhibitors to patients they perceived to be at highest risk or reserved them for bail-out use if a thrombotic complication arose during the procedure. Given the affordable cost of INTEGRILIN, physicians should not deny GP IIb-IIIa inhibitor therapy to any eligible patient.''
On February 4 of this year, 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 death or heart attack combined at 48 hours with INTEGRILIN relative to placebo.
Nearly 600,000 percutaneous coronary interventions (PCI) are performed in the U.S. each year to restore blood flow through occluded arteries that supply oxygen to heart muscle. More than sixty 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 during drug infusion when the patient is at highest risk. Upon drug discontinuation, INTEGRILIN is eliminated from the circulation, thus helping to avoid potential bleeding complications.
INTEGRILIN® (eptifibatide) Injection
INTEGRILIN is currently 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 (PCI). It is also indicated for the treatment of patients at time of PCI.
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 any history of hemorrhagic stroke; current or planned administration of another parenteral GP IIb-IIIa inhibitor; platelet count less than 100,000 per cubic millimeter; serum creatinine greater than or equal to 4.0 mg/dL (in patients with serum creatinine levels between 2.0 mg/dL and 4.0 mg/dL, a 135 mcg/kg bolus and 0.5 mcg/kg/min infusion should be administered); dependency on renal dialysis; or known hypersensitivity to any component of the product.
Previous studies have shown that bleeding is the most common complication encountered during INTEGRILIN® (eptifibatide) Injection 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 (NYSE: SGP - news) are worldwide partners for INTEGRILIN. Both companies market and sell the drug in the United States. Schering-Plough markets INTEGRILIN in Europe. COR has the right to co-promote INTEGRILIN in Europe at a later date.
COR Therapeutics, Inc. is dedicated to the discovery, development and commercialization of novel pharmaceutical products for the treatment and prevention of severe cardiovascular diseases. COR has complementary research and development programs that seek to address critical needs in severe cardiovascular care, including unstable angina, acute myocardial infarction, deep vein thrombosis, and restenosis.
In addition to historical information, this press release contains forward-looking statements regarding the Company's performance that involve risks and uncertainties. Actual results may differ materially from the anticipated results discussed in such forward-looking statements, due to factors such as results of clinical trials with INTEGRILIN and other factors discussed in the Company's SEC reports, including, but not limited to, the Company's Report on Form 10-Q for the quarter ended September 30, 2000, and Report on Form 10-K for the year ended December 31, 1999. Forward-looking statements are based on our current expectations and the Company does not intend to update such information to reflect later events or developments.
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