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Efficacy
Efficacy Introduction
Risk Reduction Pre-PCI
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Long-term Risk Reduction Post-PCI
Dosing Administration
Dosing Guidelines & Cockcroft-Gault Equation
Ease of Administration
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Infusion Delivery
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Safety
Major Bleeding in PCI
Minor Bleeding in PCI
Bleeding Rates in PROTECT
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Clinical Studies Database
PURSUIT
ESPRIT
PROTECT
CLEAR PLATELETS
Clear Platelets Introduction
Platelet Aggregation Inhibition
Reduction of Troponin-I Release
Full Prescribing Information
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Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor
Suppression Using INTEGRILIN® Therapy (PURSUIT)1

Objective

To evaluate whether inhibition of platelet aggregation with INTEGRILIN® reduces the incidence of adverse outcomes in patients with acute coronary syndromes: unstable angina, or NSTEMI.

Design

Double-blind, randomized, placebo-controlled study in 10,948 patients presenting with UA or NSTEMI.

INTEGRILIN® & Comparator Doses

Patients were randomized to:
  • Placebo (aspirin + heparin)
  • INTEGRILIN® + aspirin + heparin*

Results

Significant reduction in the primary endpoint (death or nonfatal MI within 30 days of randomization) with INTEGRILIN®.
  • INTEGRILIN® significantly reduced the primary endpoint (death or nonfatal MI at 30 days) from 15.7% with placebo to 14.2% with INTEGRILIN®; P=0.04, a 1.5% absolute reduction that persisted through 30 days
  • INTEGRILIN® achieved a significant 67% reduction in MI prior to early PCI within 72 hours of randomization (1.8% with INTEGRILIN® vs 5.5% with placebo)
  • INTEGRILIN® reduced clinical events regardless of whether patients ultimately underwent diagnostic catheterization, revascularization (ie, PCI or CABG surgery) or continued to receive medical management alone
  • The overall incidence of major bleeding was: 10.8% with INTEGRILIN® vs 9.3% with placebo
  • The majority of major bleeding occurred during CABG surgery (8.2% with INTEGRILIN® vs 8.2% with placebo)
  • The overall incidence of minor bleeding was: 13.1% with INTEGRILIN® vs 7.6% with placebo
* Either a 180-mcg/kg bolus, followed by a 2-mcg/kg/min infusion or a 180-mcg/kg bolus, followed by a 1.3-mcg/kg/min infusion. The infusion was continued for 72 hours, until hospital discharge, or until the time of CABG, whichever occurred first, except that if PCI was performed, the INTEGRILIN® infusion was continued for 24 hours after the procedure, allowing for a duration of infusion up to 96 hours. All patients received aspirin (80 to 325 mg/day). Intravenous heparin was given as a bolus of 5000 U, followed by an infusion at a rate of 1000 U/hour, with the activated partial-thromboplastin time maintained in the range of 50 to 70 seconds.

 
 

IMPORTANT PRESCRIBING AND SAFETY CONSIDERATIONS

Indications for INTEGRILIN® (eptifibatide) Injection:
  • For the treatment of patients with acute coronary syndrome (UA/NSTEMI), including patients who are
    to be managed medically and those undergoing percutaneous coronary intervention (PCI)
  • For the treatment of patients undergoing percutaneous coronary intervention (PCI), including those
    undergoing intracoronary stenting
Contraindicated in Patients With:
  • A history of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
  • Severe hypertension (systolic blood pressure >200 mm Hg or diastolic blood pressure >110 mm Hg) not adequately
    controlled on antihypertensive therapy
  • Major surgery within preceding 6 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
  • Known hypersensitivity to any component of the product
Precautions and Warnings:
  • In patients undergoing PCI, INTEGRILIN® (eptifibatide) Injection is associated with an increase in major and minor bleeding at the site of arterial sheath placement. Special care should be employed to minimize the risk of bleeding among these patients
  • If bleeding cannot be controlled with pressure, infusion of INTEGRILIN® and concomitant heparin should be stopped immediately
  • Because INTEGRILIN® inhibits platelet aggregation, caution should be employed when it is used with drugs that affect hemostasis, including thrombolytics, oral anticoagulants, NSAIDs, and dipyridamole
  • Use with other GP IIb-IIIa inhibitors should be avoided
  • INTEGRILIN® is cleared in part by the kidney and its plasma concentrations are doubled in patients with renal disease (creatinine clearance
    <50 mL/min). Therefore, the infusion dose of INTEGRILIN® needs to be reduced to 1 mcg/kg/min in these patients. INTEGRILIN® is contraindicated in patients who are dependent upon renal dialysis (please see dosing guidelines)
  • Caution should be exercised when administering eptifibatide to patients with a platelet count <100,000/mm3
  • 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 seen more commonly with INTEGRILIN® compared with placebo.

For full Prescribing Information, click here. (PDF)(1.04MB)

About Schering-Plough
Schering Corporation, of Kenilworth, NJ, is a research-based company engaged in the discovery, development, manufacturing, and marketing of pharmaceutical products worldwide. For more information, please visit the company's Web site at www.sch-plough.com.

Contact us at 1-800-222-7579

Reference:

  • The PURSUIT Trial Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. N Engl J Med. 1998;339:436–443.

INTEGRILIN is a registered trademark of Millennium Pharmaceuticals, Inc.
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