Data Support the Positive Clinical Benefits of GP IIb-IIIa Inhibitors and INTEGRILIN(R) (eptifibatide) Injection
Tuesday March 8, 4:01 pm ET
ORLANDO, March 8 /PRNewswire-FirstCall/ -- Data presented at the American College of Cardiology (ACC) Annual Scientific Sessions showed that glycoprotein (GP) IIb-IIIa inhibitors and INTEGRILIN were pivotal components of the optimal treatment strategy for reducing risk of heart attack and death in patients undergoing percutaneous coronary intervention (PCI). In the CLEAR Platelets study, INTEGRILIN, a potent GP IIb-IIIa inhibitor, provided superior platelet inhibition and prevention of heart muscle damage associated with elective coronary stenting versus clopidogrel alone. Heart muscle damage, assessed by measuring cardiac biomarkers, has been previously linked to mortality in PCI.(1) Additionally, a retrospective analysis of PCI patients undergoing interventional procedures revealed that treatment with a GP IIb- IIIa inhibitor plus heparin resulted in up to a 42% reduction in ischemic events (30 day death, myocardial infarction (MI) and urgent revascularization) compared to patients receiving other treatment regimens including bivalirudin, with or without a GP IIb-IIIa inhibitor.
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Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) announced results of the full biomarker analysis from the CLEAR Platelets study (Clopidogrel Loading with Eptifibatide to Arrest the Reactivity of Platelets). This data presentation coincided with March 2005 publication in Circulation: Journal of the American Heart Association. Study results showed that the addition of INTEGRILIN to a commonly used antiplatelet regimen containing clopidogrel provided superior platelet inhibition and prevented heart muscle damage associated with elective coronary stenting in the low-to-moderate risk patients as demonstrated by cardiac biomarkers. Additionally, results supported the vital role of INTEGRILIN in preventing heart muscle death in patients receiving coronary stents regardless of which clopidogrel dose was administered. One non-fatal bleeding event in each of the INTEGRILIN groups and one stent thrombosis in the 300 mg clopidogrel alone group were observed.
Further supporting the effective use of glycoprotein GP IIb-IIIa inhibitors in PCI treatment, results from a retrospective analysis presented by Heath Jennings, PharmD, BCPS, Saint Joseph Healthcare of Lexington, KY, demonstrated the impact of using GP IIb-IIIa inhibitors versus bivalirudin in PCI patients. Of the 6,097 patients evaluated, 3,635 were included in the final analysis. 2,811 patients received a GP IIb-IIIa inhibitor, 68% of whom received INTEGRILIN. Primary endpoints were a triple composite of death, MI, and urgent revascularization, as well as a combined efficacy and safety quadruple composite endpoint of death, MI, urgent revascularization, and TIMI major bleeding. Results showed that a GP IIb-IIIa inhibitor plus heparin (n=1881) demonstrated superior 30 day net clinical outcomes in PCI patients - up to a 27% relative reduction in the combined safety and efficacy composite endpoint compared to the other treatment regimens [including bivalirudin plus a GP IIb-IIIa inhibitor (n=1754) or bivalirudin alone (n=824)]. In addition, there was no significant difference in TIMI major or minor bleeding between treatment regimens.
Finally, at the Health Science Communications CME symposium entitled, "Optimal Treatment of ACS Patients Throughout the Spectrum of Risk," which was supported by an educational grant from Millennium and Schering-Plough Corporation, prominent cardiologists presented data from several key initiatives:
* PROTECT Trial -- A trial designed to compare the efficacy and safety of
INTEGRILIN to the direct thrombin inhibitor, bivalirudin, in PCI
patients with acute coronary syndromes. The physiologic primary
endpoint of coronary flow reserve (a measure of coronary artery flow)
favored bivalirudin, however, INTEGRILIN showed a significant
improvement in myocardial perfusion (a measure of blood flow to the
heart muscle) compared to bivalirudin. Myocardial perfusion has been
shown to correlate highly with improved survival.(2)
There was no statistically significant difference in major bleeding between the INTEGRILIN and bivalirudin arms. In the heparin and INTEGRILIN arm, no major bleeding was reported, and in the enoxaparin and INTEGRILIN arm there was a 1.5% incidence of TIMI major bleeding. New data presented at the symposium revealed that advanced age and failure to adjust the INTEGRILIN dose based upon creatinine clearance correlated with bleeding risk. Compliance with creatinine clearance- based INTEGRILIN dosing significantly reduced these bleeding complications (p=.028).
* EVENT Registry -- A registry program designed to evaluate current practice patterns in the contemporary PCI setting. The registry is unique in its consistent evaluation of both ischemic events following PCI and the effects of adjunctive pharmacotherapy including GP IIb-IIIa inhibitors. With a planned total enrollment of 7,500 patients, the registry is approaching completion of its first enrollment milestone with 2020 of 2500 patients enrolled.
* EARLY ACS Trial -- A clinical trial evaluating the benefits of early front-loaded INTEGRILIN in the treatment of patients with non-ST- segment elevation acute coronary syndrome. An update on trial design and rationale was presented.
"These data support the need for a GP IIb-IIIa inhibitor, such as INTEGRILIN, as a key component to ensure optimal outcomes before, during and after interventional procedures in the broad range of high-risk ACS and elective PCI patients," said Arthur Hiller, senior vice president, sales and marketing at Millennium, about the Symposium information. "The data presented at ACC add to a growing body of evidence regarding the proven efficacy and safety profile of INTEGRILIN which has been well-documented by large-scale, clinically-relevant studies and is further supported by six years of experience in more than 2 million patients."
About INTEGRILIN® (eptifibatide) Injection
INTEGRILIN is indicated for the treatment of patients with acute coronary syndrome (unstable angina/non-ST-segment 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.
For inquiries about INTEGRILIN, patients and physicians can call 1-(888)- 267-4MED.
INTEGRILIN is co-promoted and co-developed by Millennium Pharmaceuticals, Inc. and Schering-Plough Corporation in the U.S. and GlaxoSmithKline plc in Europe. It is also marketed by Schering-Plough Corporation in other countries.
About Millennium
Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE® (bortezomib) for Injection, a novel cancer product, co-promotes INTEGRILIN® (eptifibatide) INJECTION, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, the Company is seeking to develop breakthrough products. |
