Abstract 14433: Balancing the Benefits and Risks of Two Doses of Dabigatran Compared with Warfarin in Atrial Fibrillation
Background: In patients with atrial fibrillation (AF), dabigatran 110mg bid and 150mg bid are associated with similar rates of death. However, the higher dose reduces ischemic stroke and increases bleeding compared with the lower dose. Therefore, there is uncertainty about how to evaluate the overall benefit of the two doses.
Methods: In 18,113 AF patients in RE-LY, we used a previously developed method for integrating ischemic and bleeding events as “ischemic stroke equivalents” in order to compare a weighted benefit of two doses of dabigatran with each other, and with that of warfarin.
Results: Compared with warfarin, there was a significant decrease in ischemic stroke equivalents with both dabigatran doses: 0.92 (95% CI: 0.21 to 1.08) per 100 patient years fewer with dabigatran 110mg bid and 1.08 (95% CI: 0.34 to 1.86) fewer with dabigatran 150mg bid. There was no significant difference in ischemic stroke equivalents between the two doses: -0.16 (95% CI: -0.80 to 0.43) comparing dabigatran 150mg bid with 110 bid. When including death in the weighted benefit calculations, the results were similar.
Conclusions: On a group level both doses of dabigatran as compared with warfarin have similar benefits when considering a weighted estimate including both efficacy and safety. The similar overall benefits of the two doses of dabigatran versus warfarin support individualizing the dose based on patient characteristics and physician and patient preferences.
- © 2012 by American Heart Association, Inc.