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6% had a score of 2, and 32.5% had a score of 3 to 6. Median treatment duration was 2 years. The mean and median times in therapeutic CH5424802 purchase range (TTR) for the warfarin-treated patients was 64% and 67%, respectively. Evaluation of outcome events was centrally blinded. The results showed a reduction of the primary outcome of stroke or systemic embolism from 1.71% in the warfarin group to 1.54% per year in the D110 group (hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.74 to 1.10; p Ribonucleotide reductase rate: 0.1% with both D110 and D150 vs. 0.4% with warfarin; p selleck kinase inhibitor (16.6%). A post-randomization subgroup analysis found no significant interaction between mean center TTR and the effects of D150 or D110 concerning the primary outcome, but significant interactions with the effects on mortality, major bleeding, and the composite of ischemic and bleeding outcomes, indicating a greater benefit of dabigatran at centers with poor INR control (17). Based on the results of the RE-LY trial, dabigatran etexilate has been approved as an alternative to VKAs for stroke prevention in nonvalvular atrial fibrillation by the U.S. Food and Drug Administration, the European Medicinal Agency, and health authorities in many countries worldwide. Although the U.S. Food and Drug Administration has approved the 150 mg B.I.D. dose regimen (as well as 75 mg B.I.D. for patients with severe renal impairment, the group excluded from the RE-LY trial, based not on efficacy and safety data, but on pharmacokinetic and pharmacodynamic modeling), the Canadian regulatory authority, the European Medicinal Agency, and many other authorities worldwide have approved both the 150 mg B.I.D. and the 110 mg B.I.D. dose regimens. The ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) (18) included patients with nonvalvular atrial fibrillation at high risk of stroke, as evidenced by a CHADS2 score of ��2.