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| |  FDA Approves Lovenox For Unstable Angina and Non-Q-Wave MI COLLEGEVILLE, PA -- March 30, 1998 -- The United States Food and Drug Administration has approved Rhone-Poulenc Rorer’s Lovenox(R) (enoxaparin sodium) Injection, for the prevention of ischemic complications of unstable angina and non-Q-wave myocardial infarction (heart attack) in combination with aspirin. Unstable angina is a serious condition that can lead to heart attack or death. Lovenox is the first low-molecular-weight heparin and the first prescription drug cleared for this use in the U.S. The drug, an antithrombotic or clot-preventing agent, is also the only drug licensed for this use other than aspirin. The FDA based its clearance on the results of medical studies which showed that Lovenox plus aspirin significantly lowered the risk of the combined endpoint of death, heart attack or recurrent angina. In 1991, the last year for which figures are available, 570,000 people were hospitalised for unstable angina in the U.S. A symptom of this condition is 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. These two conditions are serious, life-threatening emergency conditions known as acute coronary syndromes. Stabilising and treating these patients is a critical first step in preventing a future and possibly fatal heart attack. 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. The new Lovenox indication is based in part on the results of a large-scale, international, multi-centre clinical trial know as ESSENCE (Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events). The study, which involved more than 3,000 patients, found that at 14 days, the combined risk of death, heart attack, or recurrent angina was significantly lower in patients treated with Lovenox and aspirin than those treated with unfractionated heparin and aspirin (16.6 percent versus 19.8 percent). At 30 days this significant advantage was sustained (19.8 percent versus 23.3 percent). "The approval of Lovenox for use in unstable angina patients marks a turning point in the treatment of acute coronary syndromes," said Marc Cohen, MD, lead author of the ESSENCE study and director, Cardiac Catheterization Laboratories, director of the division of cardiology and professor of medicine, Allegheny University of the Health Sciences in Philadelphia. "Its clear superiority to standard heparin combined with its ease of administration should facilitate rapid adoption of Lovenox for this use by the medical community." 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. Lovenox, 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. Lovenox cannot be used interchangeably with other low-molecular-weight heparins or unfractionated heparin. Patients with known hypersensitivity to heparin or pork products should not be treated with Lovenox. Lovenox should be used with extreme caution in patients with a history of heparin induced thrombocytopenia. When epidural or spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins like Lovenox or heparinoids may be at risk for developing an epidural or spinal hematoma which can result in long-term or permanent paralysis. Lovenox is the only low-molecular-weight heparin in the U.S. cleared for multiple indications including the prevention of deep-vein thrombosis in hip and knee replacement surgery, high risk abdominal surgery and the extended prevention of deep-vein thrombosis following hip-replacement surgery. Lovenox has been approved for treatment of unstable angina in 25 countries outside the U.S. More information on: Lovenox and Rhone-Poulenc Rorer.
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