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Integrilin
Clinical Pharmacology
Integrilin
| | Placebo n (%) | Eptifibatide (135/0.5) n (%) | Eptifibatide (135/0.75) n (%) |
| Patients | 1285 | 1300 | 1286 |
| Abrupt Closure | 65 (5.1%) | 36 (2.8%) | 43 (3.3%) |
| p-value vs. placebo | 0.003 | 0.030 | |
| Death, MI, or Urgent Intervention | |||
| 24 hours | 123 (9.6%) | 86 (6.6%) | 89 (6.9%) |
| p-value vs. placebo | 0.006 | 0.014 | |
| 48 hours | 131 (10.2%) | 99 (7.6%) | 102 (7.9%) |
| p-value vs. placebo | 0.021 | 0.045 | |
| 30 days | 149 (11.6%) | 118 (9.1%) | 128 (10.0%) |
| (primary endpoint) | |||
| p-value vs. placebo | 0.035 | 0.179 | |
| Death or MI | |||
| 30 days | 110 (8.6%) | 89 (6.8%) | 95 (7.4%) |
| p-value vs. placebo | 0.102 | 0.272 | |
| 6 months | 151 (11.9%)* | 136 (10.6%) * | 130 (10.3%) * |
| p-value vs. placebo | 0.297 | 0.182 | |
| *Kaplan-Meier estimate of event rate. | |||
ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with INTEGRILIN Therapy)
The ESPRIT study was a multi-center, double-blind, randomized, placebo-controlled study conducted in the United States and Canada that enrolled 2064 patients undergoing elective or urgent PCI with intended intracoronary stent placement. Exclusion criteria included MI within the previous 24 hours, ongoing chest pain, administration of any oral anti-platelet or oral anticoagulant other than aspirin within 30 days of PCI (although loading doses of thienopyridine on the day of PCI were encouraged), planned PCI of a saphenous vein graft or subsequent "staged" PCI, prior stent placement in the target lesion, PCI within the previous 90 days, a history of bleeding diathesis, major surgery within 6 weeks of treatment, gastrointestinal bleeding within 30 days, any stroke or structural CNS abnormality, uncontrolled hypertension, PT >1.2 times control, hematocrit <30%, platelet count <100,000/mm 3 , and pregnancy.
Patient age ranged from 24 to 93 (mean 62) years and 73% of patients were male. The study enrolled 90% Caucasian, 5% African American, 2% Hispanic and 1% Asian patients. Patients received a wide variety of stents. Patients were randomized either to placebo or eptifibatide administered as an intravenous bolus of 180 µg/kg followed immediately by a continuous infusion of 2.0 µg/kg/min, and a second bolus of 180 µg/kg administered 10 minutes later (180/2.0/180). Eptifibatide infusion was continued for 18-24 hours after PCI or until hospital discharge, whichever came first. Each patient received at least one dose of aspirin (162-325 mg) and 60 U/kg of heparin as a bolus (not to exceed 6000 Units) if not already receiving a heparin infusion. Additional boluses of heparin (10-40 U/kg) could be administered in order to reach a target ACT between 200 and 300 seconds.
Generic Name: Eptifibatide
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