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| |  Clot-Preventing Drug Cuts Heart Attack Risk Death In Chest Pain Sufferers PHILADELPHIA -- August 14, 1997 -- Results of a large-scale, international clinical study known as the ESSENCE trial, published in this week's issue of The New England Journal of Medicine, found that patients with unstable angina or a non-Q-wave heart attack treated with the low-molecular-weight heparin Lovenox(R) (enoxaparin sodium) Injection and aspirin had a significantly reduced risk of death, myocardial infarction (heart attack) and recurrent angina over patients treated with unfractionated intravenous heparin and aspirin, the most commonly used treatment for unstable angina. Unstable angina is a serious condition that can lead to a heart attack or death. An estimated 1.5 million people worldwide were diagnosed with unstable angina in 1994. The condition is characterized by severe chest pain that signals the patient is at increased risk of heart attack and death. Unstable angina is caused by a decrease in blood and oxygen to the heart muscle and can occur when the patient is at rest or during minimal exertion. Non-Q-wave heart attack is a condition in which blockage to the coronary artery partially damages the heart wall. Patients suffering from a non-Q-wave heart attack are considered to be at even higher risk for death than individuals with unstable angina. The onset of both conditions can be attributed to a blood clot resulting from the rupture of a coronary atherosclerotic plaque, which blocks the arteries supplying blood to the heart muscle. "Our study showed enoxaparin to be the first antithrombotic or clot-preventing agent proven superior to unfractionated heparin, which is the current standard of care in unstable angina treatment," said Marc Cohen, MD, lead author of the ESSENCE study and director, Cardiovascular Diseases and Catheterization Laboratories, Allegheny University Hospitals, Hahnemann and MCP, and professor of medicine at Allegheny University of the Health Sciences in Philadelphia. About ESSENCE The ESSENCE trial (Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events) was a prospective, randomized, double-blind, parallel-group trial that involved 3,171 patients at 176 clinical centers in North and South America and Europe. Patients diagnosed with unstable angina or non-Q-wave heart attack were randomly assigned to receive either 1 mg/kg of enoxaparin every 12 hours by subcutaneous injection or adjusted-dose unfractionated heparin, administered as an initial bolus injection followed by continuous intravenous infusion. All patients received a daily dose of aspirin in the range of 100 mg to 325 mg for 30 days after randomization. Study entry and treatment started after hospital admission and within 24 hours of the last episode of angina. Treatment continued until hospital discharge (up to a maximum of eight days), or until the patient experienced death or heart attack, or underwent a revascularization procedure. The average duration of therapy was 3.5 days. Patients returned for a follow-up evaluation 14 days after randomization, and a follow-up phone call was conducted at least 30 days after randomization. At 14 days, only 16.6 percent of patients in the enoxaparin arm experienced one of the combined endpoints of death, heart attack or recurrent chest pain versus 19.8 percent of patients in the heparin arm, a 16-percent relative reduction for the enoxaparin group. At 30 days, the advantage was sustained with a 15-percent relative risk reduction for the enoxaparin group. Hemorrhage is the most common side effect associated with the use of antithrombotics. There was no increased risk of major bleeding complications in the study. However, when major and minor bleeding were combined, the study showed a statistically significant increased incidence in overall bleeding with enoxaparin sodium. About Enoxaparin Sodium Enoxaparin sodium, a unique chemical entity in a distinct class of antithrombotic agents known as low-molecular-weight heparins, is obtained by alkaline degradation of heparin benzyl ester and is about one-third the molecular size of standard heparin. Enoxaparin sodium is marketed by Rhone-Poulenc Rorer in the United States under the tradename Lovenox and in other parts of the world as Clexane(R) or Klexane(R). Allegheny University of the Health Sciences is part of the Allegheny Health, Education and Research Foundation (AHERF), a statewide integrated academic health system based in the Philadelphia region and in Pittsburgh. In addition to the University and the Allegheny University Hospitals, AHERF includes, in Philadelphia, St. Christopher's Hospital for Children, and in Pittsburgh, Allegheny General Hospital, and the Allegheny University Medical Centers, as well as a network of community-based physician practices. More information on: Lovenox, Aspirin, Rhone-Poulenc Rorer
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