DALLAS, Nov. 12 /PRNewswire-FirstCall/ -- Schering-Plough Corporation today announced that results from the Time to Integrilin Therapy in Acute Myocardial InfarctioN -Thrombolysis In Myocardial Infarction (TITAN)- TIMI-34 study, indicated that the early initiation of INTEGRILIN(R) in the emergency department prior to percutaneous coronary intervention (PCI) for acute ST-segment-elevation myocardial infarction (STEMI) yielded superior coronary artery blood flow, as assessed by TIMI frame counts, the study’s primary endpoint. Also, superior myocardial perfusion, as assessed by TIMI myocardial perfusion grade, was found by early initiation of INTEGRILIN, compared to initiation in the cardiac catheterization laboratory. Results from the study were presented during a symposium hosted by the Texas Heart Institute, on Saturday, Nov. 12, 2005.
“The longer a patient has poor blood flow to the heart, the higher the risk of cardiovascular damage,” said C. Michael Gibson, MD, Brigham and Women’s Hospital and principal investigator in the TITAN-TIMI-34 study. “Since delays in restoring blood flow via angioplasty are frequent, this trial demonstrated that the strategy of early intervention in the emergency department with INTEGRILIN improved blood flow prior to angioplasty,” added Dr. Gibson.
INTEGRILIN is approved for use in ACS (UA/NSTEMI), and patients undergoing PCI, but is not approved for use in STEMI patients.
Time to Integrilin Therapy in Acute Myocardial InfarctioN (TITAN)-TIMI-34 study
TITAN was a Phase IV, randomized, open-label, multicenter trial designed to evaluate the efficacy of early initiation of INTEGRILIN in 343 patients undergoing primary PCI for acute STEMI. The primary endpoint of the trial was the Corrected TIMI Frame Count (CTFC).
The study demonstrated that early initiation of INTEGRILIN in the emergency department prior to primary PCI for STEMI, produced statistically significant faster blood flow through the blocked artery. The time required for blood to go through the artery, as assessed by TIMI Frame Count, sped up significantly from 84.3 frames among those treated later in the catheterization lab to 77.5 frames (p=0.049) among those treated early in the emergency department. In addition, the percentage of patients with normal blood flow into the heart muscle itself (normal TIMI myocardial perfusion grade) improved from 14.2 percent among patients treated later in the catheterization laboratory to 24.3 percent (p=0.026) among those treated earlier in the emergency department.
These improvements in blood flow and perfusion did not come at the expense of any increase in TIMI major or minor bleeding, which was 6.9 percent among those treated early in the emergency department versus 7.8 percent among those treated later in the catheterization laboratory. Specifically, in this study, there were no strokes or intracranial hemorrhages.
“These study results add to a growing body of evidence about the potential value of early initiation of INTEGRILIN in ACS patients,” said Robert J. Spiegel, MD, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
The Texas Heart Institute symposium was supported, in part, by an unrestricted educational grant from Schering-Plough.
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 www.integrilin.com.
About TIMI
TIMI stands for Thrombolysis In Myocardial Infarction, a clinical trial group. The corrected TIMI frame count (CTFC) is a simple, objective index of coronary blood flow that can be broadly and inexpensively applied. This measure of the time for dye to traverse a coronary artery is both accurate and reproducible. In the CTFC method, the number of frames required for dye to reach a standardized distal landmark is counted. The first frame taken for measurements is the frame in which dye touches both borders of the coronary artery and moves forward with at least 70 percent of the artery coated. The TIMI flow grade classification scheme is a widely used method for the assessment of coronary artery flow in acute coronary syndromes. Flow in coronary arteries is classified as grade 0 (no flow), grade 1 (penetration without perfusion), grade 2 (partial perfusion) or grade 3 (complete perfusion). The TIMI myocardial perfusion grade (TMPG) is an angiographic method used to assess myocardial perfusion or blood flow into the heart muscle.
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 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.
Schering-Plough Corporation
CONTACT: Media - Jason Ford, +1-908-298-7127, Investors - Alex Kelly,+1-908-298-7436, both of Schering-Plough Corporation
Web site: http://www.schering-plough.com/
