DALLAS, Nov. 14 /PRNewswire-FirstCall/ -- Schering-Plough Corporation and Sinai Center for Thrombosis Research of Baltimore today announced that results from a prospective analysis of the CLEAR PLATELETS (Clopidogrel Loading with Eptifibatide to Arrest the Reactivity of Platelets) study showed that adding INTEGRILIN(R), a potent glycoprotein (GP) IIb-IIIa inhibitor, to a loading dose of clopidogrel, a commonly used oral antiplatelet therapy, produced superior reduction in inflammation in patients undergoing elective percutaneous coronary intervention (PCI) stenting. In this study, the degree of inflammation was assessed by levels of tumor necrosis factor (TNF)-alpha and C-Reactive Protein (CRP) and other factors. Results from this analysis were presented at the American Heart Association Scientific Sessions in Dallas, Texas.
The study results demonstrated that compared to a strategy of clopidogrel alone, adding INTEGRILIN reduced the release of inflammatory markers. A marked reduction in platelet aggregation and active GP IIb-IIIa expression (p < 0.001) with the addition of INTEGRILIN was associated with a decrease in CRP and TNF-alpha release (p < 0.001) that resulted in the lowest levels of these markers.
"Reducing inflammation is of growing interest in the field of cardiology, and these findings indicate that INTEGRILIN may play a role in reducing inflammation in elective PCI patients," said Paul Gurbel, MD, principal investigator in the CLEAR PLATELETS study, director of Sinai Center for Thrombosis Research at Sinai Hospital of Baltimore and associate professor at Johns Hopkins University, Baltimore. "Further studies are necessary to determine the clinical implications of these findings."
Schering-Plough and Sinai Center for Thrombosis Research also announced the initiation of the CLEAR PLATELETS II study, designed to evaluate the effects of the addition of INTEGRILIN to an antithrombotic regimen of aspirin (325 mg) plus clopidogrel (600 mg) plus bivalirudin in elective PCI patients.
CLEAR PLATELETS II will directly compare the levels of inhibition of platelet aggregation achieved with high-dose clopidogrel used in combination with bivalirudin plus INTEGRILIN versus high-dose clopidogrel with bivalirudin alone, as well as the time to achieve peak levels of inhibition with each regimen. This study will also examine the release of cardiac biomarkers associated with heart-muscle death and inflammatory markers in patients receiving the two treatment regimens.
"This new study will investigate whether adding INTEGRILIN to a commonly used antithrombotic regimen will help protect patients from irreversible heart-muscle death," stated Dr. Gurbel.
"Schering-Plough is committed to continuing investigation of the benefits of INTEGRILIN. Recently, we announced the initiation of the RESISTOR trial evaluating INTEGRILIN in patients undergoing percutaneous coronary intervention," said Robert J. Spiegel, MD, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute. "In addition, Schering-Plough is continuing to discover and develop new therapies that, along with INTEGRILIN, have the potential to further improve the outcomes of patients with cardiovascular disease."
CLEAR PLATELETS Inflammation Analysis
CLEAR PLATELETS was a randomized study involving 120 patients undergoing elective PCI with stenting who were treated with 300 mg clopidogrel (C); 300 mg C + eptifibatide (E); compared to 600 mg C; and 600 mg C + E. Assessment of inflammation was measured at baseline and at 24 hours; markers included levels of tumor necrosis factor (TNF)-alpha, C- Reactive Protein (CRP), soluble CD-40 Ligand (sCD-40L), platelet bound p-selectin (p-selectin), and soluble p-selectin (sp-selectin). Demographics and baseline markers were the same between groups.
Study results demonstrated that the addition of INTEGRILIN consistently produced the largest reductions in TNF-alpha (p<0.001) and CRP (p=0.002). 600 mg C+E reduced CRP significantly compared to 600 mg C (p=0.03) and 300 mg C (p=0.05). 300 mg C+E reduced CRP compared to 600 mg C (p=0.005) and 300 mg C (p=0.002). 600 mg C+E and 300 mg C+E reduced TNF-alpha compared to 600 mg C and 300 mg C (p<0.001). 600 mg C reduced TNF-alpha compared to 300 mg C (p<0.001). There were no differences in CD-40, p-selectin, or sp-selectin between groups. In the absence of eptifibatide, high dose clopidogrel was superior to low dose clopidogrel.
Important Safety Information About INTEGRILIN(R) (eptifibatide) Injection in the U.S.
INTEGRILIN is indicated for the treatment of patients with acute coronary syndrome (unstable angina/non-ST-segment-elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). 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 any 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. In the registration trials, 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.
Full prescribing information for INTEGRILIN is available at http://www.integrilin.com.
About Sinai Hospital of Baltimore
Sinai Hospital of Baltimore is a member of LifeBridge Health, a regional health organization, which includes Northwest Hospital Center, Levindale Hebrew Geriatric Center and Hospital, Jewish Convalescent & Nursing Home and related subsidiaries and affiliates.
About Schering-Plough
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release contains certain "forward-looking" statements, including statements relating to the market potential for INTEGRILIN. Forward-looking statements relate to expectations or forecasts of future events. Many factors could cause actual results to differ materially from Schering-Plough's forward-looking statements. Schering-Plough does not assume the obligation to update any forward-looking statement. The extent that INTEGRILIN will be prescribed will be determined by market forces, economic factors, product availability, current and future branded, generic or over- the-counter competition, the regulatory process, among other uncertainties. For further details and a discussion of other risks and uncertainties that may affect forward-looking statements, see the company's Securities and Exchange Commission filings, including the company's third quarter 2005 10-Q.
SESSION AOP.11.1, ABSTRACT 447 Media Contact: Jason Ford (908) 298-7127 Investor Contact: Alex Kelly (908) 298-7436
Schering-Plough CorporationCONTACT: Media: Jason Ford, +1-908-298-7127, or Investor: Alex Kelly,+1-908-298-7436, both for Schering-Plough Corporation
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