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Title: ACC: ReoPro (Abciximab) Reduces Mortality Risk After Heart Attack
URL: http://www.pslgroup.com/dg/214F16.htm
Doctor's Guide
March 20, 2002


ATLANTA, GA -- March 20, 2002 -- Results of numerous studies show that treating patients with the anti-platelet drug ReoPro® (abciximab, Centocor, Lilly) following a heart attack helps increase blood flow to the heart, thus reducing patients risk of death, recurrent heart attack, and the need to re-open clogged arteries.
The data, presented at the 51st annual meeting of the American College of Cardiology (ACC), highlight the strength of ReoPro in treating patients with diabetes, visible and non-visible thrombus (blood clots), and complex lesions (arteries with multiple blockages).

In particular, a study presented by Dr. Albert Schomig, Deutsches Herzzentrum, Munich, Germany, just published in the March 16 edition of The Lancet, the combination of ReoPro and a stent appeared to significantly limit further damage to the heart muscle compared with a combination of ReoPro and a thrombolytic (clot buster).1,2 Other data presented by Dr. Mahesh Mulumudi of the Ochener Medical Institution, New Orleans, suggested that ReoPro improved blood circulation to the heart, as measured by Myocardial Blush Grade (MBG), a sensitive indicator of future heart problems.3 Diabetic patients experienced a particularly beneficial effect with ReoPro treatment.

A separate analysis examining left ventricular (LV) function (impaired LV function can often lead to heart failure and death) in 47 patients who underwent angioplasty, led by Dr. Anna Petronio of the University of Pisa, Pisa, Italy, reported that treatment with ReoPro helped to maintain blood flow to the heart muscle and improved heart muscle function at both 30 days and six months.4

"ReoPro has consistently demonstrated an ability to not only prevent blood clots, but also improve microvascular perfusion and myocardial blood flow, all of which enhance long-term clinical outcomes," said Dr. Dean Kereiakes, Medical Director, The Carl and Edyth Lindner Center for Research and Education, and CEO of The Ohio Heart Health Center, Cincinnati, Ohio.

Two additional presentations from the GUSTO V (Global Use of Strategies to Open Occluded Arteries in Acute Myocardial Infarction) trial that studied the potential use of ReoPro in combination with a thrombolytic as an alternative treatment option for heart attack patients. The first, presented by Dr. Magnus Ohman of Duke University, Durham, North Carolina, reported that patients treated with the combination of ReoPro and the thrombolytic Retavase® (reteplase, Centocor) were 34 percent less likely to experience a recurrent heart attack than patients treated with Retavase alone (2.3 percent vs. 3.5 percent, respectively).5 A second GUSTO V presentation, by Dr. Mitchell Krucoff of Duke University, reported that the ReoPro and

Retavase combination restored overall blood flow more quickly and improved the stability of the target vessel.6

About ReoPro

ReoPro is a member of a class of drugs known as glycoprotein (GP) IIb/IIIa inhibitors that target the platelet component of blood clots and reduce the complications associated with blood flow restrictions during coronary intervention, including angioplasty and stenting. ReoPro blocks the formation of thrombus, helping to restore or maintain flow in the coronary arteries. Giving patients ReoPro while they undergo procedures to open their arteries has been proven to reduce the risk of death or heart attack. ReoPro has demonstrated this benefit at 30 days, six months and one year. In addition, Phase III study results from the EPISTENT trial have demonstrated that using ReoPro in combination with stents reduces the risk of death by 57 percent one year after percutaneous coronary intervention (PCI) compared to stents alone. Importantly, in a pooled-analysis of three phase III trials ReoPro has been shown to lower the one-year mortality rate of diabetes patients undergoing PCI, who are at particularly high risk for complications, to a rate similar to that of non-diabetics.

ReoPro, derived from a monoclonal antibody, c7E3 Fab, takes a unique approach to preventing blood clots by targeting the GP IIb/IIIa receptors and binding to them, inhibiting platelet aggregation and reducing thrombin generation. ReoPro is currently indicated as an adjunct to PCI for the prevention of cardiac ischemic complications in patients undergoing PCI and in patients with unstable angina not responding to conventional medical therapy when PCI is planned within 24 hours.

More than one million patients have been treated with ReoPro. It has been studied more extensively than any other GP IIb/IIIa inhibitor and it has consistently demonstrated durable and robust clinical efficacy over the long-term.

ReoPro has the potential to increase the risk of bleeding, particularly in the presence of anticoagulation such as heparin or a clot-buster.

References:

1 Schomig A, et. al. Clinical Outcomes of Patients with Acute Myocardial Infarction Randomized Either Coronary Stenting Plus Abciximab or Fibrinolysis Plus Abciximab (STOPAMI-2 Trial). The Journal of the American College of Cardiology, Vol 39, No. 5 (Supplement A): 2002.

2 Kastrati A, et. al. Myocardial Salvage After Coronary Stenting Plus Abciximab Versus Fibrinolysis Plus Abciximab in Patients with Acute Myocardial Infarction: A Randomised Trial. The Lancet, Vol. 359, March 16, 2002.

3 Mulumudi MS, et. al. Role of Abciximab in the Preservation of Myocardial Microcirculation During Mechanical Reperfusion For Acute ST-Segment Elevation Myocardial Infarction. The Journal of the American College of Cardiology, Vol 39, No. 5 (Supplement A): 2002.

4 Petronio AS, et. al. Microcirculation Recovery After Primary Coronary Angioplasty in Patients with Acute Myocardial Infarction Treated with Abciximab or Intracoronary Adenosina. The Journal of the American College of Cardiology, Vol 39, No. 5 (Supplement A): 2002.

5 Ohman EM, et. al. Prevention of Reinfarction Using Half-Dose Reteplase and Abciximab: Observations From the GUSTO 5 Trial. The Journal of the American College of Cardiology, Vol 39, No. 5 (Supplement A): 2002.

6 Krucoff MW, et. al. The Abciximab ST-Recovery ON AMI (ASTRONAMI) GUSTO V Substudy: Enhanced Early Speed, Stability, Quality of Reperfusion with Anti-platelet Augmented Thrombolytic Therapy for ST-Elevation AMI. The Journal of the American College of Cardiology, Vol 39, No. 5 (Supplement A): 2002.


SOURCE: Eli Lilly and Company

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