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| |  Dabigatran Superior to Warfarin for Reducing Strokes, Major Bleeding Events in Patients With AF: Presented at AHA By Deborah Brauser ORLANDO, Fla -- November 23, 2009 -- Treatment with dabigatran etexilate can decrease the number of strokes and major bleeding events for patients with atrial fibrillation (AF) compared with warfarin, according to a post hoc analysis from the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) trial presented here at the American Heart Association (AHA) Scientific Sessions 2009. In the original RE-LY trial, 18,113 patients with AF were enrolled from 951 centres in 44 countries. To measure efficacy, the patients (mean age, 72 years) were randomised to receive 110 mg (n = 6,015) or 150 mg (n = 6,076) dabigatran twice daily or dose-adjusted warfarin (n = 6,022). “While oral anticoagulants reduce stroke in AF, their efficacy is related to the time in treatment range [TTR],” explained lead investigator Lars Wallentin, MD, Uppsala Clinical Research Center, Sweden, during a late-breaking clinical science presentation on November 15. Although the mean TTR in warfarin-treated patients in the RE-LY trial was 64%, the number varied greatly among the 44 participating countries, ranging from 41% up to 77%. For this study, in which the researchers investigated the effect of the average TTRs of participating centres on trial outcomes, the primary endpoint was stroke or systolic embolism after 1 to 3 years of follow-up. Vascular events and mortality were secondary endpoints. Although the results showed no statistical difference in the number of strokes or systolic embolisms experienced per year between the group treated with warfarin and the lower-dose dabigatran group (1.7% vs 1.5%, respectively), the patients receiving the 150-mg dose appeared superior at 1.1%. These results remained consistent regardless of international normalised ratio (INR) control, reported Dr. Wallentin. The 110-mg dose of dabigatran showed a trend towards superiority for decreased major bleeding over the warfarin group (2.7% vs 3.4% affected, respectively). No significant difference was found in major bleeding for the 150-mg dose or overall in relation to centre-based INR control. Both doses of dabigatran were superior to warfarin for intracranial bleeding regardless of centre-based INR control. Dabigatran also showed an advantage for all vascular events at centres with poor INR control. Mortality rates were reduced with dabigatran 150 mg, but no significant difference was found with the 110-mg dose. Both doses of dabigatran seemed superior to warfarin at sites with poor INR control and both doses were similar to warfarin in those with average-to-good INR control. “Our conclusions are very cautious,” concluded Dr. Wallentin. “For the primary efficacy and safety, the main results are consistent, showing a reduction in stroke and major bleeding in dabigatran compared with warfarin, irrespective of centre-based INR control, and in intracranial bleeding. For secondary outcomes, such as vascular events and mortality, the advantages of dabigatran may be greater at sites with poor INR control.” Funding for this study was provided by Boehringer-Ingelheim. [Presentation title: Efficacy and Safety of Dabigatran Compared to Warfarin at Different Levels of INR Control for Stroke Prevention in 18,113 Patients With Atrial Fibrillation in the RE-LY Trial. Abstract LBCT-20002]
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