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Three Anticoagulant Studies May Change Current Medical Practice Including New Data Revealing That Preventative Use of Aspirin and Heparin is Not Effective in Reducing Recurrent, Unexplained Miscarriages
Date:12/6/2009

sent this study during an oral session on Monday, December 7, at 3:00 p.m. in Room 275-277.

Once-Daily Oral Rivaroxaban Versus Placebo in the Long-Term Prevention of Recurrent Symptomatic Venous Thromboembolism, the EINSTEIN-Extension Study [Abstract #LBA-2]

Venous thromboembolism (VTE), a condition in which a blood vessel is blocked by a clot, is a common and potentially life-threatening disorder. In the United States, there are more than 200,000 new cases of VTE that occur annually.(2) Treatment for acute VTE typically consists of an anticoagulant, such as a vitamin K inhibitor, for a period of six to 12 months. Following this, the decision to continue the treatment to prevent future clots is controversial. Long-term use of vitamin K inhibitors carries the risk of serious side effects, such as major bleeding, and requires regular laboratory monitoring to optimize the dose while reducing these risks. As an alternative, the safety and efficacy of rivaroxaban, an oral anticoagulant that does not require continued monitoring and dose adjustment, was studied for long-term therapy and found to be safe and effective.

Researchers enrolled 1,197 patients in a double-blind trial involving 280 study sites in 28 countries. Prior to enrollment, the study participants had completed six to 12 months of anticoagulant treatment for acute VTE and were randomized to receive either 20 mg of rivaroxaban once daily (602 patients) or placebo (594 patients) for an additional six to 12 months.

Treatment with rivaroxaban was found to be both safe and effective. Only eight patients (1.3 percent) on rivaroxaban showed signs of recurrent VTE events, compared with 42 patients (7.1 percent) in the placebo arm. In the rivaroxaban arm, four patients (0.7 percent) experienced major bleeding, though none of these events were fatal or at a critical site. Non-major bleeding, such as a nose bleed, skin hematoma (a swelling of blood), or blood in t
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SOURCE American Society of Hematology
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