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| | | ![]() ESC: Pre-Hospital Administration of Retavase (Reteplase) May Save Time to Treatment In Heart-Attacks STOCKHOLM, SWEDEN -- September 3, 2001 -- A study presented yesterday at the European Society of Cardiology (ESC) Congress appears to demonstrate the benefits of the clot-dissolving agent Retavase® (reteplase) in the treatment of heart-attack patients. The study, known as ER-TIMI 19, reported that doctors could accelerate the treatment of heart attack patients by 33 minutes by administering Retavase in the ambulance rather than waiting until the patient reached the hospital. According to the National Institutes of Health, half of the 500,000 deaths from heart attacks each year occur within the first hour of experiencing symptoms such as chest pain and shortness of breath. Typically, patients receive a clot-busting therapy only after they have arrived at the emergency department.* "Retavase, a fibrinolytic agent that is administered in two fixed doses and does not require a patient to be weighed before it is administered, facilitates treatment in the pre-hospital setting," said Donald Rosenberg, M.D., professor of clinical medicine at the University of Miami School of Medicine and medical director of Miami-Dade Fire Rescue. "Time is of the essence when treating heart-attack patients, and giving Retavase in the ambulance has been shown to be safe and feasible, and to save time to treatment." According to the National Heart, Lung, and Blood Institute, the government's leading health agency for cardiovascular disease, patients wait an average of 2.3 hours from the onset of symptoms until the start of treatment with a cardiovascular medication. Yet, the rate of lives saved is highest among patients who are treated with fibrinolytics within the first hour of symptoms. Michael Waller, M.D., Centocor's senior director, clinical trials management, North America, added, "Retavase was tested in the ER TIMI 19 trial because the double-bolus administration without weight adjustment facilitates its use in the ambulance. The preliminary results of ER-TIMI 19 reported that pre-hospital administration of Retavase enables earlier treatment of heart attacks." He noted that the most important first step in treating heart attacks is to open the artery, and Retavase has been proven to restore blood flow in significantly more patients, compared with t-PA, at 60 and 90 minutes after administration. The ER-TIMI 19 trial is a multicenter, open-label study involving 20 geographically diverse emergency medical systems in North America. The primary endpoint is time saved with pre-hospital initiation of Retavase in fibrinolytic-eligible patients with ST elevation on a 12-lead ECG, transmitted to hospital-based medical control physicians. The study found that for patients receiving pre-hospital treatment with Retavase, the median time from EMS arrival to the first Retavase bolus was 31 minutes, compared with 64 minutes for those given Retavase at the hospital. The rapid pre-hospital administration of Retavase worked to stabilize heart- attack patients, with 29% already showing a greater than 50% resolution of their elevated ST segments, an electrocardiogram indicator of heart health, by the time they arrived at the emergency room. Complete ST-segment resolution (>70%) was achieved in 15 percent of pre-hospital-treated patients by emergency department arrival and 54 percent by 90 minutes after the first bolus of Retavase. To date, twelve (5.4%) deaths and two (0.9%) intracranial hemorrhages have occurred, rates that are consistent with other fibrinolytic trials. According to the American Heart Association, an estimated 1.1 million Americans suffer heart attacks each year. Approximately 450,000 of these heart attacks are recurrent heart attacks. Nearly all heart attacks are caused by a thrombus-a blood clot that obstructs the flow of blood to the heart, thereby depriving it of oxygen and nutrients. Blood clots are composed of a protein called fibrin and disk-shaped blood elements known as platelets. While clot-busting, or thrombolytic, agents such as Retavase target only the fibrin component of clots, drugs known as glycoprotein IIb/IIIa inhibitors (e.g., ReoPro) target the platelet component of blood clots. Retavase is a recombinant biologic cardiology care product administered for the treatment of acute myocardial infarction, or heart attack, to improve blood flow in the heart. When compared with older thrombolytic agents, Retavase distinguishes itself by its ease of administration - a simple two- bolus injection given 30 minutes apart. 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. As with all fibrinolytic agents, Retavase therapy increases the risk of bleeding, including intracranial bleeding, and should be used only in appropriate patients. In addition, fibrinolytic therapy increases the absolute risk of strokes, including hemorrhagic stroke, in patients of advanced age. * The TIMI 19 trial was conducted in the following states: Arkansas, Connecticut, Florida, Georgia, Indiana, Kentucky, Massachusetts, Minnesota, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington. Retavase® is a registered trademark of Centocor, Inc. SOURCE: Centocor, Inc. Related Links: Retavase (reteplase) and Centocor, Inc.
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