Sanofi-aventis, a leading drug manufacturer, announced that two long term clinical studies are showing clear benefits for patients with Acute Coronary Syndrome taking Clexane Lovenox.
The announcement is based on one year results for two landmark studies known as ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment, Thrombolysis in Myocardial Infarction Study 25) and STEEPLE (SafeTy and Efficacy of Enoxaparin in
Percutaneous Coronary Intervention Patients) studies.
ExTRACT TIMI 25 is a major clinical trial that supported the worldwide submission and subsequent approval by the FDA and some European countries of the new Lovenox indication for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
"This was a very large trial with conclusive results" said Dr. Elliott Antman, M.D., Senior Investigator and Director of the Samuel A.Levine Cardiac Unit at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study. Dr Antman added: "The persistence of significant net clinical benefit a full year after treatment is further evidence of the viability of the strategy of using enoxaparin (Lovenox) as adjunctive anticoagulant therapy to fibrinolysis in the STEMI patient population."
In regard to safety, the STEEPLE trial found that there was not a statistical significant difference in 1-year death rates in patients taking enoxaparin (Lovenox) at levels of 0.5mg/kg or 0.75 mg/kg. Ischemic events and major bleeding were found to be independent predictors of death at 1 year.
According to the press release, results are looking good for the efficiency and safety of CLEXANE® LOVENOX® drug. The two long term studies have shown that there are clear long term benefits for patients taking the drug on patients with acute ST-segment elevation myocardial infarction (STEMI) or elective percutaneous intervention (PCI).
The announcement is based on one year results for two landmark studies known as ExTRACT-TIMI 25 (Enoxaparin and Thrombolysis Reperfusion for Acute Myocardial Infarction Treatment, Thrombolysis in Myocardial Infarction Study 25) and STEEPLE (SafeTy and Efficacy of Enoxaparin in
Study: Acute Coronary Syndrome Patients May Benefit from Clexane Lovenox
Date: September 3, 2007ExTRACT TIMI 25 is a major clinical trial that supported the worldwide submission and subsequent approval by the FDA and some European countries of the new Lovenox indication for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI).
"This was a very large trial with conclusive results" said Dr. Elliott Antman, M.D., Senior Investigator and Director of the Samuel A.Levine Cardiac Unit at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School, and lead investigator of the ExTRACT-TIMI 25 study. Dr Antman added: "The persistence of significant net clinical benefit a full year after treatment is further evidence of the viability of the strategy of using enoxaparin (Lovenox) as adjunctive anticoagulant therapy to fibrinolysis in the STEMI patient population."
In regard to safety, the STEEPLE trial found that there was not a statistical significant difference in 1-year death rates in patients taking enoxaparin (Lovenox) at levels of 0.5mg/kg or 0.75 mg/kg. Ischemic events and major bleeding were found to be independent predictors of death at 1 year.
According to the press release, results are looking good for the efficiency and safety of CLEXANE® LOVENOX® drug. The two long term studies have shown that there are clear long term benefits for patients taking the drug on patients with acute ST-segment elevation myocardial infarction (STEMI) or elective percutaneous intervention (PCI).
Analysis of the data showed that there was a significant decrease in the risk of emergency hospitalizations for acute coronary syndrome (ACS), cerebrovascular accident (CVA), and pneumonia
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