Dabigatran Etexilate

To test the efficacy and safety of Dabigatran Etexilate over an extended period of time, a phase III RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy) was conducted. It served to compare two fixed doses of Dabigatran Etexilate, both of which were administered blindly, and compare with an open label use of warfarin in patients that were suffering from atrial fibrillation (Connolly et al. 2009). The methodology of this study was as follows: trial participants were randomly assigned to either one of two doses of Dabigatran Etexilate, or warfarin. The two doses of Dabigatran Etexilate were either 110 mg or 150 mg taken twice daily, and warfarin was administered in tablets of 1, 2, or 3 mg and was adjusted locally to an internationalized ratio (INR) of 2.0 to 3.0, and
First, the rates of myocardial infarction were 0.53% with warfarin, 0.72% with 110 mg BID (twice daily) and 0.74% with 150 mg BID Dabigatran Etexilate. Second, the major bleeding occurrence observed was 3.36% in people in warfarin, 2.71% for patients with 110 mg BID and 3.11% on 150 mg BID Dabigatran Etexilate. The significance of this study was that it was the first one to prove that a regimen of 150 mg BID of Dabigatran Etexilate was more effective in reducing embolic events in patients in patients that suffered from atrial fibrillation than warfarin was able to (Connolly et al. 2009). The occurrence of cerebral haemorrhage was also significantly reduced, and the higher risk of myocardial infarction was outweighed by the benefits of Dabigatran Etexilate in other measures. The negative that was mentioned by this study was the fact that at this point in time, Dabigatran Etexilate was about 7,000 fold the cost of warfarin, so although it was much more effective it was very expensive for the individual as well as health care facilities (Connolly et