Fondaparinux significantly reduces risk of death for myocardial infarction patients


Patients with myocardial infarction, who have a certain pattern on an electrocardiogram, significantly reduced their risk of death and having another myocardial infarction at 30 days with the medication Fondaparinux ( Arixtra ), without an increased risk of bleeding and stroke.

Of 55 million deaths globally every year, about 30 percent are from cardiovascular diseases. Of these, 40 percent to 50 percent are likely to be due to acute myocardial infarction ( AMI ).
Primary percutaneous coronary intervention ( PCI ) offers benefits over thrombolytic therapy, but access to this procedure, particularly in developing countries, is limited.
Trials of medications such as unfractionated heparin ( UFH ), direct thrombin inhibitors, and Enoxaparin ( Clexane / Lovenox ) have thus far failed to demonstrate reductions in the death rate, and bleeding is substantially increased when these agents are used with Acetylsalicylic acid ( Aspirin ) and thrombolytic therapy. There is a clear need for an effective, inexpensive, and safe antithrombotic agent for patients with STEMI ( ST-segment elevation myocardial infarction ).

Salim Yusuf, of McMaster University and Hamilton Health Services, Ontario, Canada, and colleagues with the OASIS-6 trial conducted a study to evaluate the effect of Fondaparinux compared with standard approaches to antithrombotic therapy in patients with STEMI in preventing death or reinfarction at 30 days. These outcomes were also assessed at 9 days and at study end ( minimum of 3 and maximum of 6 months ).
The study included 12,092 patients with STEMI from 447 hospitals in 41 countries who were randomized to receive Fondaparinux 2.5 mg once daily for up to 8 days or usual care ( placebo in those in whom UFH is not indicated or UFH for up to 48 hours followed by placebo for up to 8 days in patients with STEMI ).

The researchers found that death or reinfarction at 30 days was significantly reduced from 11.2 percent of 6,056 patients in the control group to 9.7 percent of 6,036 patients in the Fondaparinux group, a risk reduction of 14 percent. These benefits were observed at 9 days ( 8.9% ) placebo vs. ( 7.4% ) Fondaparinux, a 17 percent risk reduction; and at study end ( 14.8% ) placebo vs. ( 13.4% ) Fondaparinux, a 12 percent reduction.
Risk of death was significantly reduced throughout the study.
However, there was no benefit in those undergoing primary PCI. There was a tendency to fewer severe bleeding events in the Fondaparinux group.

" In summary, Fondaparinux reduces mortality and reinfarction early, and this benefit persists long term," the authors write. "… results from … OASIS-6 confirm the value and safety of Fondaparinux as a simple and widely applicable antithrombotic therapy in a broad group of patients with acute coronary syndrome."

Source: Journal of American Medical Association, 2006


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