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| |  ESC CONGRESS: Combination Of ReoPro, Low-Dose Retavase Facilitates Coronary Flow In Heart-Attack Patients BARCELONA, SPAIN -- Aug. 30, 1999 -- New findings from an international clinical trial show that combining Centocor, Inc.’s and Eli Lilly and Co.’s ReoPro(R) (abciximab), an antiplatelet drug that prevents the formation of blood clots, with a reduced dose of Centocor’s clot-buster Retavase(R) (reteplase) restores optimal coronary blood flow in more heart-attack patients, compared with using Retavase alone. These results, presented at the 21st annual congress of the European Society of Cardiology, are from the SPEED (Strategies for Patency Enhancement in the Emergency Department, also known as the GUSTO IV Pilot Trial) trial. The GUSTO IV pilot trial, jointly developed by Centocor and Eli Lilly and Co. is a randomised, multicentre, international trial of 528 heart-attack patients who arrived at the hospital within six hours of experiencing symptoms. The primary objective of the trial was to evaluate the percentage of patients achieving high-level blood flow through the affected coronary artery at the first angiogram performed 60 to 90 minutes after initiation of ReoPro and differing doses of Retavase, given 30 minutes apart, ReoPro alone, or a standard dose of Retavase alone. In the GUSTO IV pilot study, 61 percent of the patients who received ReoPro, half the standard dose of Retavase, and 60 units per kilogram (U/kg) of heparin, achieved optimal coronary artery blood flow (also referred to as TIMI 3 flow) within 60 to 90 minutes. By comparison, 47 percent who received a full dose of Retavase alone achieved this level of early blood flow through the affected artery. "These results suggest that a combination of the antiplatelet drug ReoPro and a reduced dose of the clot-busting drug Retavase may offer therapeutic advantages over standard thrombolytic therapy," said Magnus Ohman, M.D., associate professor of medicine, Duke University School of Medicine, Durham, N.C. "Retavase is the only clot-buster that offers this advantage of fast, easy dosing in two injections given 30 minutes apart." As with all fibrinolytic agents, Retavase therapy increases the risk of bleeding, including intracranial bleeding. In this trial, the rate of complications, such as major bleeding rates, stroke and intracranial hemorrhage, observed in the study were within the range expected with therapies and procedures that break up blood clots. The findings from the GUSTO IV pilot trial provide the rationale for a larger clinical trial on combination therapy with ReoPro and Retavase. GUSTO IV-AMI (Global Use of Strategies to Open Occluded Arteries) is an ongoing, international, multicentre, randomised open-label phase III trial that is evaluating patient outcomes 30 days after treatment in approximately 16,600 patients. These patients will be randomised to receive ReoPro and a reduced dose of Retavase plus heparin, or a standard dose of Retavase. ReoPro -- a unique dual receptor glycoprotein (GP) IIb/IIIa and alpha V beta 3 antagonist -- reduces the complications associated with Percutaneous Coronary Intervention (PCI) by preventing the formation of blood clots that commonly intensify during the procedure. When blood platelets encounter an injured site, such as one produced by angioplasty, they adhere to it and form a thin, protective layer. These and other platelets then become activated, exposing certain binding sites on their surface known as glycoprotein receptors. A circulating protein, fibrinogen, latches on to the glycoprotein receptors and causes platelets to link together and aggregate into a blood clot. 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. It also acts to inhibit alpha V beta 3 receptors on platelets and vascular cells, which are believed to be implicated in blood clotting and smooth-muscle cell migration after vascular injury. The most common side effect of ReoPro is bleeding at the site of catheter insertion. However, bleeding events can be reduced to a level similar to placebo by the use of low-dose, weight-adjusted heparin regimens, early sheath removal and meticulous care of the site of catheter insertion. Retavase is a potent fibrinolytic or clot buster that is administered for the treatment of acute myocardial infarction, or heart attack, to improve blood flow in the heart. Retavase distinguishes itself by its ease of administration, which is especially beneficial in the emergency department or in the ambulance prior to arriving to the chest pain centre. Retavase also restored blood flow in significantly more patients, compared with t-PA, at 60 and 90 minutes after administration. However, the relationship between coronary artery patency and clinical efficacy has not been established.
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