The cost of drugs appear to be one of the greatest sources of escalating health care costs. God only knows it's no longer from doctor's fees. I'll be the first to attest to that! Therefore, I fail to understand where the pot of gold is going to be at the end of the rainbow.
Doc, A friend who attended the convention told me the HMO guys were all over this one. BTW, I appreciate your plight.
INTEGRILIN -eptifibatide- Significantly Reduces Complications of Intracoronary Stenting in Study Highlighted Today At American College of Cardiology Conference
Business Wire - March 14, 2000 10:17
ANAHEIM, Calif.--(BW HealthWire)--March 14, 2000--Investigators announced today that INTEGRILIN(R) (eptifibatide) Injection, marketed by COR Therapeutics, Inc. (NASDAQ: CORR) and Schering-Plough Corporation (NYSE: SGP), significantly reduced the combined incidence of death, heart attack, need for urgent repeat intervention, or the need for thrombotic bail-out therapy from 10.5 percent with placebo to 6.6 percent (P = 0.0015) over the 48 hours following non-urgent balloon angioplasty combined with intracoronary stenting. These data represent the final results for the primary endpoint of the ESPRIT trial for all 2,064 patients enrolled.
The analysis revealed that INTEGRILIN reduced the combined occurrence of death plus heart attack at 48 hours from 9.2 percent to 5.5 percent, a statistically significant 40 percent relative reduction or 3.7 percentage point absolute reduction (P = 0.0013).
"These results clearly reinforce our conviction that GP IIb-IIIa inhibitors should be the standard of care for patients undergoing intracoronary stenting," said James E. Tcheng, MD, lead investigator for ESPRIT and Associate Professor of Medicine at Duke University Medical Center. "Given the affordable cost of INTEGRILIN relative to the benefit it offers, hospitals should have no reason to deny therapy to all eligible patients."
Importantly, INTEGRILIN significantly reduced the occurrence of heart attack following the stenting procedure from 9.0 percent with placebo to 5.4 percent (P = 0.0015), a 40 percent reduction. "Previous studies have demonstrated post-procedural heart attack to be a strong predictor for longer-term debilitating illnesses, such as congestive heart failure, or death," noted Dr. Tcheng.
Consistent with previous clinical trials with INTEGRILIN, increased major bleeding, primarily at the site for PCI catheter placement, was reported.
The final 48-hour results of the ESPRIT study of INTEGRILIN were featured today at the late-breaking clinical trials session of the 49th Scientific Sessions of the American College of Cardiology in Anaheim, California.
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 with the wide variety of intracoronary stents currently used in clinical practice. In ESPRIT, INTEGRILIN was dosed as a 180-mcg/kg bolus, immediately followed by a 2-mcg/kg/min infusion, then followed by a second 180-mcg/kg bolus ten minutes later. The infusion was continued until hospital discharge for up to 18 to 24 hours.
On February 4th of this year, 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, an independent Data Safety Monitoring Committee (DSMC) determined that enrollment in the ESPRIT study should be stopped early. The highly statistically significant effect was shown to be maintained out to 30 days in the 1,384 patients for whom data was available at the time of the interim analysis by the DSMC. The final 48-hour, primary endpoint data analysis presented today represents the results for all of the 2,064 patients enrolled in ESPRIT at the time of its early termination.
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 a 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 a 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 a PCI procedure.
INTEGRILIN(R) (eptifibatide) Injection 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 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 undergoing 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/mm3; 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 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 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 currently is developing a long-acting oral GP IIb-IIIa inhibitor, cromafiban.
Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing, and marketing of pharmaceutical products worldwide.
COR forward-looking statement: In addition to the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Actual results of the Company's activities may differ significantly from the potential results discussed in such forward-looking statements. These forward-looking statements are based on current expectations and the Company assumes no obligation to update this information. A full discussion of COR Therapeutics' operations and financial condition, and specific factors that could cause the Company's actual performance to differ from current expectations, can be found 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, 1999, and Report on Form 10-K for the year ended December 31, 1998.
INTEGRILIN(R) is a registered trademark of COR Therapeutics, Inc.
CONTACT: COR Therapeutics, Inc.
Jackie Jeffries
650/244-6893
or
Schering-Plough Corporation
Denise Foy
973/822-7464
or
Investors:
Burns McClellan, Inc.
Lisa Burns
212/213-0006
or
Media:
GCI Group
Elizabeth Duncan
415/974- |
