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| |  Retavase Provides Superior Benefits In Patients With Blood Clots In The Lung MALVERN, PA -- Aug. 2, 1999 -- Study results reveal that Centocor, Inc.’s clot-buster Retavase(R) (reteplase recombinant) demonstrated favourable results in patients with pulmonary embolism (PE). The study, published in the July issue of the American Heart Journal, compared Retavase to the standard clot-busting treatment, t-PA. PE, which is caused by blood clots that travel from veins in the legs or pelvis and block one or more arteries in the lungs, results in more than 50,000 deaths in the United States every year. Rapid reperfusion is required to prevent death, which can occur within 30 minutes of the acute PE. The trial, the first to examine the effectiveness of Retavase in treating PE, showed that Retavase, which is easily administered in two intravenous injections, rapidly improved blood flow through the pulmonary artery. Currently, t-PA is the approved treatment of PE. The authors report that a significant reduction in total pulmonary resistance was seen within 30 minutes after starting treatment with Retavase compared to two hours after initial t-PA therapy. Pulmonary resistance reflects both blood flow and blood pressure in the arteries of the lung, parameters that in turn reflect the amount of blood pumped by the heart. As pulmonary resistance decreases, the right ventricle of the heart, which pumps blood into the arteries of the lung, functions better. The multicentre, randomised, controlled open-label trial included 36 patients who received either Retavase, given as two 10 unit shots, or t-PA, given as a continuous infusion for two hours. All patients received the blood-thinner heparin as soon as they were diagnosed and before clot-busting therapy began. The most common adverse event was bleeding at the site of the injection. There were two cases of bleeding -- one in each treatment group -- that were considered severe. Three patients died during the study, two given t-PA and one given Retavase. Overall, the difference in the number of patients in each group experiencing adverse side effects was not statistically significant. 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 other thrombolytic agents, Retavase restores blood flow more rapidly in significantly more patients when 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. Retavase also 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.
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