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 significant reduction in major bleeding and similar efficacy compared with UFH confirms Lovenox(R) is an appropriate anticoagulant for elective PCI,” said Dr. Gilles Montalescot, Professor of Cardiology at the Institute of Cardiology, Hopital de la Pitie Salpetriere, Institut du Coeur, Paris, France
According to the American Heart Association, more than 13 million Americans have a history of Coronary artery disease (CAD) and 7.5 million have experienced an acute heart attack. CAD causes
approximately 17 million deaths per year: the equivalent of 1 out of every 3 deaths worldwide.
The ExTRACT-TIMI 25 and STEEPLE one year results were presented during the European Society of Cardiology (ESC) Congress held in Vienna, Austria.
Sanofi-aventis. New Study Findings Confirm CLEXANE(R)/LOVENOX(R) Long-Term Clinical Benefit in Patients Suffering From Acute Coronary Syndrome. URL: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/09-02-2007/0004655276&EDATE=
Know the Facts, Get the Stats. American Heart Association. URL: Know the Facts, Get the Stats