GlaxoSmithKline: Research shows Arixtra superior to standard acute coronary syndrome therapy

By Ted A. Knutson

Washington, March 14 - GlaxoSmithKline plc said Monday a new study has demonstrated the superiority of its antithrombotic product Arixtra (fondaparinux sodium) to standard therapy in acute coronary syndrome in patients with ST elevation MI (Stemi).

The overall results of the study demonstrated superiority of fondaparinux to standard therapy (unfractionated heparin or a placebo) in reducing risk of death or recurrent heart attack (risk reduction of 14% at day 30, p=0.008), with a significant reduction observed as early as day nine (risk reduction of 17%, p=0.003).

Furthermore, fondaparinux showed a significant reduction in all cause mortality (secondary endpoint) at day nine (risk reduction 13%, p=0.043), which was maintained until the end of the study (risk reduction 12%, p=0.029).

In the Oasis 6 trial, which stands for Organization to Assess Strategies for Ischaemic Syndrome, the incidence of severe hemorrhage at day nine was similar between fondaparinux and standard therapy treated patients. In addition, Oasis 6 showed that fondaparinux was associated with a significant net benefit-risk as assessed by the composite of efficacy and safety endpoints of death, recurrent MI and severe hemorrhage at all time points (at day 30 risk reduction was 14%, p=0.005).

The trial evaluated more than 12,000 patients and was presented at the American College of Cardiology's 55th Scientific Session in Atlanta.

GlaxoSmithKline is based in Philadelphia and is a research-based pharmaceutical and health care company.

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