To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Study Shows Pre-Hospital Administration Of Retavase (Reteplase) Can Accelerate Important Treatment Of Heart-Attack Patients URL: http://www.pslgroup.com/dg/2177F6.htm Doctor's Guide July 3, 2002
U.S. Congressman Mark Foley Says Findings Show Need to Authorize Pre-Hospital Administration in Every State MALVERN, PA -- July 3, 2002 -- A study published in the Journal of American College of Cardiology found that the time required to begin the treatment of heart attack patients could be cut by more than half by having the clot-dissolving drug Retavase® (reteplase) administered by ambulance crews rather than waiting until the patients reached a hospital. The trial, known as Early Retavase-Thrombolysis In Myocardial Infarction (ER-TIMI) 19, was conducted in states where pre-hospital administration of fibrinolytic drugs such as Retavase currently is authorized*. It found that for patients receiving pre-hospital treatment, the median time was 31 minutes from the arrival of Emergency Medical Services (EMS) to the first injection of Retavase. This was less than half of the median time of 63 minutes it had taken to start in-hospital thrombolytic treatment in the cohort of historical control patients who had been admitted to the same hospitals during the year prior to the start of the study. "Beginning drug treatment of heart attack patients as soon as possible -- even before they reach the hospital -- is an important goal because the longer a patient waits to receive treatment, the greater the extent of permanent cardiac damage," said David Morrow, M.D., M.P.H., a cardiologist at Brigham and Women's Hospital in Boston and one of the study's principal investigators. "These findings show that it is feasible to begin treatment with Retavase in the ambulance, rather than waiting until patients reach a hospital." "We know that time is of the essence when a heart-attack patient's life is on the line," said U.S. Representative Mark Foley (R-FL), a member of the U.S. House Ways and Means Committee who has backed federal legislation to authorize pre-hospital administration of life-saving drugs by paramedics. "This study also shows that valuable time could be saved if the laws in every state allowed patients to be treated with breakthrough therapies before they get to the hospital." "Retavase is administered as two intravenous injections 30 minutes apart, with the same dosing used in all patients independent of their body weight," said Michael Waller, M.D., Centocor's senior director, clinical trials management, North America. "This convenient and straightforward mode of administration makes Retavase ideally suited to be given outside the hospital," he noted. "Following pre-hospital treatment with Retavase, physicians still have the option to send the patient directly on to an interventional procedure if necessary. Retavase is also the only fibrinolytic proven superior to t-PA in restoring TIMI 3 flow at 60 and 90 minutes after administration, a critically important first step in treating heart attacks." He added that Retavase is the leader among clot-dissolving drugs in the AMI market. About the ER-TIMI 19 Study The ER-TIMI 19 trial is a multicenter, open-label study involving 315 patients in 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 63 minutes for those given Retavase at the hospital. The rapid pre-hospital administration of Retavase worked to stabilize heart attack patients, with 26% 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 resolution (>70%) of elevated ST-segments was achieved in 14 percent of pre-hospital-treated patients by emergency department arrival and 49 percent by 90 minutes after the first bolus of Retavase. Fourteen deaths (4.7%) and three intracranial hemorrhages (1.0%) were reported. About Heart Attack According to the American Heart Association, an estimated 1.1 million Americans suffer heart attacks each year. 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. Clot- dissolving, or fibrinolytic, agents such as Retavase target the fibrin component of clots. According to the National Heart, Lung, and Blood Institute, the government's leading health agency for cardiovascular disease, the rate of lives saved is highest among heart attack patients who are treated with clot-dissolving drugs within the first hour of symptoms. And the National Institutes of Health says that 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. About Retavase Retavase is the most widely prescribed fibrinolytic in the United States. It 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. Please see http://www.Retavase.com for full prescribing information. About Centocor, Inc. Centocor, a Johnson & Johnson company, is a leading biopharmaceutical company that creates, acquires and markets cost-effective therapies that yield long-term benefits for patients and society. Its products, developed primarily through monoclonal antibody technology, help physicians deliver innovative treatments to improve human health and restore patients' quality of life. For more information, visit Centocor's web site at http://www.centocor.com. *Pre-hospital administration of Retavase is currently authorized in the states of 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. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. 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