If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Clexane/Lovenox Receives 11 Approvals As Treatment for Unstable Angina COLLEGEVILLE, PA. and ANTONY, FRANCE -- January 15, 1998 -- Rhone-Poulenc Rorer (RPR), announced it has received marketing clearance for Clexane(R)/Lovenox(R) (enoxaparin sodium) in the treatment of unstable angina and non-Q-wave myocardial infarction in combination with aspirin in 11 countries. The countries granting approval are Bangladesh, Egypt, Jordan, The Netherlands, New Zealand, Poland, Romania, Slovak Republic, Spain, Switzerland and the United Kingdom. This brings the total number of approvals for Clexane/Lovenox in this indication to thirteen, including Denmark and France announced in September 1997. Unstable angina is a serious condition that can lead to a heart attack or death. More than one million people(A) each year are diagnosed with unstable angina. The condition is characterised 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. The applications filed worldwide for this indication were based in part on an international multicentre clinical study, known as the ESSENCE trial (Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events), which showed Lovenox/Clexane to be more effective than unfractionated intravenous heparin in reducing the combined endpoint of death, heart attack or recurrent angina (chest pain) in patients diagnosed with unstable angina or non-Q-wave heart attack. Unfractionated intravenous heparin is the current standard of therapy for treatment of unstable angina and non-Q-wave myocardial infarction. Hemorrhage is the most common side effect associated with the use of heparins. There was no increased risk of major bleeding complications in the study. However, when major and minor bleedings were combined, the study showed a statistically significant increased incidence in overall bleeding with enoxaparin sodium mainly due to an increased rate of hematoma at the injection site. Clexane/Lovenox is administered as a 1mg/kg dose twice daily with aspirin (100-325 mg once daily). Treatment should be prescribed for at least two days and continued until the patient is clinically stable. The standard duration of treatment is from two to eight days. Clexane/Lovenox, a low-molecular-weight heparin from a distinct class of antithrombotic agents, is about one-third the molecular size of standard heparin. As the number one selling low-molecular-weight heparin in the world, Clexane/Lovenox has been marketed in Europe since 1987 (also under the name Klexane(R)) and in the United States and Canada since 1993. More information on: Lovenox
|
