A study headed by Boehringer Ingelheim, the maker of Pradaxa, suggests a fixed dose of dabigatran therapy twice daily is just as effective as a dose-adjusted warfarin for treating venous thromboembolism (VTE), a blood clot related condition.

A total of 2,564 patients with VTE were randomly assigned, 1274 to the dabigatran group and 1265 to the warfarin group in a double-blind, double-dummy trial. The remaining 25 patients, 7 from the dabigatran group and 18 from the warfarin group, did not receive medication. The patients were evaluated for up to 6 months from April 2006 through November 2008 and were asked to report symptoms of VTE or bleeding at the end.

At the end of the study, 30 patients in the dabigatran group reported recurrent VTE and 20 reported major bleeding compared to 27 in the warfarin group who reported recurrent VTE and 24 who reported major bleeding. Any episode of bleeding was recorded for 205 dabigatran patients and 277 warfarin patients.

Venous thromboembolism is the third most common cause of vascular death after myocardial infarction and stroke, affecting 1 to 2 adults per 1,000 annually, according to the New England Journal of Medicine. It is a combination of two deadly blood clot related conditions, pulmonary embolism and deep vein thrombosis. Typical treatment is administered using anticoagulant medication and Vitamin K, which is used to reverse adverse effects such as internal bleeding.

”Treatment with dabigatran was as effective as warfarin therapy, which achieved INR values within the therapeutic INR range 60% of the time – a rate that is consistent with good-quality management of warfarin dosing,” concluded the researchers.

Pradaxa is currently at the heart of hundreds of lawsuits against Boehringer Ingelheim. Since the drug was approved in the U.S. in October 2010, it has caused several hundred deaths as well as thousands of patients to suffer internal bleeding, heart attack, and brain hemorrhages. If you have taken Pradaxa and have experienced adverse side effects, we encourage you to speak with an attorney today.