Sanofi-Aventis said that one-year findings from two studies evaluating Lovenox confirm clear net clinical benefit for patients with acute ST-segment elevation myocardial infarction compared to unfractionnated heparin.
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The first trial showed that in patients with acute ST-segment elevation myocardial infarction (STEMI) treated with fibrinolysis, at one year, the primary endpoint of death or nonfatal myocardial infarction remained significantly in favor of Lovenox (enoxaparin) vs unfractionnated heparin (UFH) (15.8% vs 17.0%). Net clinical benefit was also significantly in favor of enoxaparin compared to UFH through one year of follow up (16.0% vs 17.3%).
The second trial shows that the composite of all cause death at one year and major bleeding was 3.1% for Lovenox 0.5mg/kg, 3.4% for Lovenox 0.75mg/kg, 3.3% for the two Lovenox arms combined and 4.7% for UFH.
There were low and statistically similar one-year death rates in the enoxaparin groups (0.5mg/kg or 0.75mg/kg) and UFH during and after elective percutaneous intervention (PCI). In addition to patient risk factors, ischemic events and major bleeding were found to be independent predictors of death at one year.
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