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www.fdanews.com/articles/69751-data-support-positive-benefits-of-gp-iib-iiia-inhibitors-integrilin-injection

Data Support Positive Benefits of GP IIb-IIIa Inhibitors, Integrilin Injection

March 11, 2005

Data presented at the American College of Cardiology 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 (Clopidogrel Loading with Eptifibatide to Arrest the Reactivity of 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.

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 percent reduction in ischemic events compared to patients receiving other treatment regimens, including bivalirudin, with or without a GP IIb-IIIa inhibitor.

Millennium Pharmaceuticals announced results of the full biomarker analysis from the CLEAR Platelets study, showing 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 nonfatal bleeding event in each of the Integrilin groups and one stent thrombosis in the 300-mg clopidogrel-alone group were observed.