FDAnews Drug Daily Bulletin

STUDY: BLEEDING RISKS LOWER IN ARIXTRA THAN LOVENOX

April 18, 2006
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GlaxoSmithKline's (GSK) antithrombotic drug Arixtra is as effective as sanofi-aventis' Lovenox in treating patients with acute coronary syndromes (ACS) and carries a lower risk of major bleeding, according to a new study.

Arixtra (fondaparinux sodium) reduced bleeding at day nine by 48 percent compared to Lovenox (enoxaparin), noted the study published April 6 in the New England Journal of Medicine. The study found the products to have comparable efficacy at day nine.

Arixtra is used to prevent deep vein thrombosis, and is not approved for use in patients with ACS, noted GSK. ACS diseases, which include unstable angina and heart attacks, are a major cause of mortality and morbidity in Western countries, the company said.

Studies have shown that blood thinners can substantially reduce the risk of heart attacks in patients with ACS, GSK noted. But blood thinners also present a risk of major bleeding, and there is a need for effective therapies for ACS with a lower incidence of this side effect, the firm indicated.

The study, known as OASIS 5, included more than 20,000 ACS patients at 576 sites in 41 countries. The primary safety objective was to evaluate major bleeding events up to day nine. Arixtra was associated with a 2.2 percent incident rate compared to Lovenox' 4.1 percent rate, the study found. For the primary composite endpoint -- preventing death, myocardial infarction and refractory ischemia at day nine -- Arixtra had an incident of 5.8 percent and Lovenox had an incident rate of 5.7 percent.