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| |  ReoPro (Abciximab) Significantly Improves Outcomes in Patients Receiving Stents INDIANAPOLIS, IN -- June 21, 2001 -- Two new studies, TARGET and ADMIRAL, published today in The New England Journal of Medicine show that treatment with the GPIIb/IIIa receptor blocker ReoPro® (abciximab) plus a stent reduces the chance of having a heart attack or the need for emergency revascularization (coronary angioplasty) in two different patient types. The TARGET study showed ReoPro superior to tirofiban in a broad range of patients undergoing scheduled stenting procedures. In the ADMIRAL study - a study of stenting in heart attack patients - patients receiving ReoPro showed a nearly 53 percent relative risk reduction in the composite endpoint of death, second heart attacks and emergency revascularizations out to six months, compared to placebo (7.4 percent to 15.9 percent, p=0.02). For the individual endpoint of emergency revascularization, patients receiving ReoPro showed a nearly 70 percent relative risk reduction out to six months, compared to placebo (2.0 percent to 6.6 percent, p=0.049). "These studies show that combining ReoPro with a stent is a feasible, safe and effective way of managing patients undergoing coronary stenting," said Professor Gilles Montalescot, University Hospital, Pitié-Salpétrière, Paris. "These results strengthen our understanding of how to best use GPIIb/IIIa inhibitors to stabilize a broad range of patients receiving stents, reduce the need for urgent revascularization and in many cases, save lives." The first trial, called TARGET (Do Tirofiban and ReoPro Give Similar Efficacy Trial), a randomized, double-blind, trial of 4,809 patients, compared the use of ReoPro and tirofiban before undergoing revascularization with the intent of placing a stent. The trial had been designed and powered to show that tirofiban and ReoPro provided similar benefit. However, the researchers found that significantly fewer patients receiving ReoPro experienced the primary composite endpoint of death, heart attack or the need for urgent revascularization (6.0 percent to 7.6 percent, p=0.038). ReoPro also showed a significant reduction of heart attack alone, compared to tirofiban (5.4 percent to 6.9 percent, p=0.04). The relative benefit was consistent regardless of age, gender, and presence or absence of diabetes. In addition, there were no significant differences between groups on major bleeding or transfusions. Tirofiban, however was associated with a lower rate of minor bleeding episodes and thrombocytopenia than ReoPro. The second trial -- ADMIRAL (Abciximab before Direct angioplasty and stenting in Myocardial Infarction Regarding Acute and Long term follow-up) - was a randomized, double-blind, placebo controlled study that compared ReoPro to placebo in coronary stenting of patients with acute myocardial infarction. All patients also received heparin, ticlopidine and aspirin. The study results showed that starting ReoPro within 12 hours after having a heart attack significantly reduced the combined endpoint of death, second heart attack or the need for emergency revascularization of the stented vessel at 30 days (6.0 percent to 14.6 percent, p=0.01) and six months (7.4 percent to 15.9 percent, p=0.02) compared to placebo. Of all of the ADMIRAL sub-groups studied, patients with diabetes obtained particular benefit from ReoPro. Compared to diabetes patients receiving placebo, diabetes patients receiving ReoPro experienced a significant reduction in the individual endpoints of death (0 percent vs 16.7 percent, p=0.02), and revascularization of the vessel for any reason (13.8 percent vs 37.5 percentp=0.046). "ReoPro is recognized as the reference standard in prevention of further cardiac events around percutaneous coronary intervention -- interventions like angioplasty and stents," continued Professor Gilles Montalescot. "These results confirm ReoPro is an important part of our treatment regimen." ReoPro, a unique multi-receptor inhibitor of glycoprotein (GP) IIb/IIIa, alpha V beta 3, and MAC-1, reduces the ischemic complications associated with angioplasty and stenting. Giving patients ReoPro while they undergo procedures to open their arteries has been proven to reduce their risk of death or heart attack. ReoPro has demonstrated this benefit at 48 hours, 30 days, six months and one year. In addition, Phase III study results have demonstrated that using ReoPro in combination with stents reduces the risk of death by 57 percent one year after the procedure compared to stents alone. 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. ReoPro is currently indicated as an adjunct to percutaneous coronary intervention 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. ReoPro has the potential to increase the risk of bleeding, particularly in the presence of anticoagulation, such as heparin or a clot-buster. The most common side effect of ReoPro is bleeding. Bleeding rates were reduced in the CAPTURE (c7E3 Fab Anti Platelet Therapy in Unstable Refractory Angina) trial, and further reduced in the EPILOG (Evaluation in PTCA to Improve Long-Term Outcome with ReoPro GP IIb/IIIa Blockade) trial by use of modified dosing regimens and specific patient-management techniques. These modifications included the use of low-dose, weight-adjusted heparin and early sheath removal. In EPILOG, the incidence of major bleeding was not significantly different from that in patients receiving placebo. SOURCE: Lilly Related Link: The New England Journal of Medicine.
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