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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

tach from its point of origin and travel through the heart to the lungs, causing a potentially fatal condition known as a pulmonary embolism.

Currently, patients with VTE are treated with a blood thinner known as warfarin, which has many burdensome interactions with other medications and foods and requires frequent monitoring of the dosage. However, this study shows that an oral drug called dabigatran etexilate, which does not have these disadvantages, is as safe and effective as warfarin for combating VTE.

To compare the two drugs, an international team of researchers conducted a randomized, double-blind trial of 2,539 patients with acute VTE. For six months, roughly half of the patients in the trial (1,274) were given a fixed dose of 150 mg of dabigatran etexilate twice daily, while the other half (1,265 patients) were given warfarin once daily in doses adjusted to an International Normalized Ratio (INR) of 2.0 to 3.0. INR is a blood test needed to monitor the effects of warfarin therapy to ensure an adequate, yet safe, dose is taken; in this study, the test was performed, on average, every 11 days.

The improvement seen in both groups from the treatments was similar. After six months of treatment, only 2.4 percent of the dabigatran etexilate group (30 patients) and 2.2 percent of the warfarin group (27 patients) experienced recurrent VTE. The safety of the two drugs was also comparable. In the dabigatran etexilate arm, 207 patients experienced bleeding (including 20 patients with major bleeding) versus 280 patients in the warfarin arm (including 24 with major bleeding). Other possible side effects, including death, acute coronary syndromes, and abnormalities in liver function tests, were infrequent in the two groups.

"We are excited by these findings and feel that they will change the standard of care for venous thromboembolism, which affects a large number of our patients," said lead study author Sam Schulman, MD, Prof
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SOURCE American Society of Hematology
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