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Dr. Christian Ruff
Mr Manesh Patel
By Christian Ruff, (Boston, United States of America)View Discussant report
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List of AuthorsChristian T. Ruff, MD, MPH, Robert P. Giugliano, MD, SM, Eugene Braunwald, MD, David A. Morrow, MD, MPH, Sabina A. Murphy, MPH, Julia F. Kuder, MPH, Naveen Deenadayalu, MPH, Petr Jarolim, MD, PhD, Joshua Betcher, PhD, Minggao Shi, PhD, Karen Brown, PhD, Indu Patel, MD, Michele Mercuri, MD, PhD, Elliott M. Antman, MD
BackgroundThe ENGAGE AF-TIMI 48 trial in 21,105 patients with AF showed that both the high (HD) and low dose (LD) regimens of the factor Xa (FXa) inhibitor edoxaban were as effective as warfarin in preventing stroke or systemic embolism (SEE), while reducing major bleeding and cardiovascular death (CVD). The relationships between edoxaban dose, pharmacokinetics, pharmacodynamics, and clinical outcomes have not been previously reported.MethodsWe correlated edoxaban dose, concentration, and anti-FXa activity and compared efficacy and safety outcomes with warfarin stratified by dose reduction status.ResultsPatients who met clinical criteria for dose reduction had higher stroke, bleeding, and CVD rates. The dose of edoxaban ranged from 15 - 60 mg, resulting in a 2 to 3-fold gradient of mean drug exposure (16.0 - 48.5 ng/mL) and mean anti-FXa activity (0.35 - 0.85 IU/mL). Dose reduction decreased mean exposure by 29% and 35% and mean anti-FXa activity by 25% and 20% in the HD and LD regimens, respectively. Despite the decrease in anti-FXa activity, dose reduction preserved the relative efficacy of edoxaban compared with warfarin (stroke or SEE: HD p-interaction=0.85, LD p-interaction=0.99) and provided even greater safety (major bleeding: HD p-interaction 0.02, LD p-interaction=0.002). ConclusionThis first analysis of an oral anticoagulant that combines pharmacokinetic, pharmacodynamics, and clinical outcomes demonstrates that dose reduction lowered HD and LD edoxaban concentrations and anti-FXa levels, yet preserved efficacy with even greater relative reductions in bleeding compared with warfarin. The therapeutic window appears narrower for bleeding than thromboembolism.
By Manesh Patel, (Durham, United States of America)See Presenter abstract
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Clinical Trial Update Hot Line: Stable CAD and atrial fibrillation
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