『S4E8 - Why Efficacy Matters: Dissecting the Early Termination of Asundexian (Factor XI Series Part 1 of 2)』のカバーアート

S4E8 - Why Efficacy Matters: Dissecting the Early Termination of Asundexian (Factor XI Series Part 1 of 2)

S4E8 - Why Efficacy Matters: Dissecting the Early Termination of Asundexian (Factor XI Series Part 1 of 2)

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Welcome to Part 1 of our "What's it Worth?" deep dive into the next generation of anticoagulation. In this episode, host Dr. Diana Langworthy and student co-hosts Tim Haas and Caleb Nelson-Lange take on the OCEANIC-AF trial. This Phase 3, non-inferiority trial was designed to prove that the oral Factor XIa inhibitor, asundexian, could match the gold-standard apixaban in preventing stroke while significantly reducing bleeding. However, the trial took a dramatic turn when it was stopped early—not for safety, but for futility in efficacy . We unpack why asundexian failed to clear the non-inferiority hurdle and what this means for the "Factor XI hypothesis. In this episode, we move past the excitement of a "bleeding-free" anticoagulant to look at the clinical necessity of efficacy. We explore the challenge of going head-to-head with apixaban—widely considered the safest and most effective agent in our current toolkit—and discuss whether the "Factor XI hypothesis" was flawed or if the bar was simply set too high for this specific molecule. Key Takeaways OCEANIC-AF was halted because asundexian was inferior to apixaban for preventing stroke and systemic embolism . In this trial, asundexian went head-to-head with apixaban, the current market leader for safety and efficacy . While asundexian showed numerical trends toward less bleeding, those gains were overshadowed by the increased risk of ischemic events compared to standard-of-care apixaban . Is the Factor XI class dead on arrival, or was asundexian just the wrong molecule? ---> Tune in to find out! Episode Resources Link to the Coagulation Cascade: https://www.bleeding.org/educational-programs/education/online-education/the-clotting-cascade Featured Study Piccini, J. P., Patel, M. R., Steffel, J., Ferdinand, K., Van Gelder, I. C., Russo, A. M., ... & OCEANIC-AF Steering Committee and Investigators. (2025). Asundexian versus apixaban in patients with atrial fibrillation. New England Journal of Medicine, 392(1), 23–32. https://doi.org/10.1056/NEJMoa2407105 Host Diana Langworthy, PharmD, BCPS | Associate Professor, University of Minnesota College of Pharmacy | Clinical Pharmacist, Inpatient Internal Medicine, M Health Fairview East Bank Hospital Student Co-Hosts Caleb Nelson-Lange | PharmD Candidate | Class of 2026 | University of Minnesota College of Pharmacy Tim Haas | PharmD Candidate | Class of 2028 | University of Minnesota College of Pharmacy Join the Conversation Have a study you'd like us to decode on a future episode? Email whatsitworthpodcast@gmail.com or share how you're navigating evidence in practice—I love hearing how clinicians and learners think through uncertainty. Or you can find me on my socials - Check out my Beacons for links to my TikTok and LinkedIn https://beacons.ai/diana.the.pharm.d.etective Additional References & Guidelines Joglar, J. A., Chung, M. K., Armbruster, A. L., et al. (2024). 2023 ACC/AHA/ACCP/HRS guideline for the diagnosis and management of patients with atrial fibrillation. Journal of the American College of Cardiology, 83(1), 109–279. https://doi.org/10.1016/j.jacc.2023.08.017 Ruff, C. T., Patel, S. M., Giugliano, R. P., et al. (2024). Abelacimab versus rivaroxaban in patients with atrial fibrillation. New England Journal of Medicine, 391(1), 21–33. https://doi.org/10.1056/NEJMoa2406674Piccini, J. P., Caso, V., Connolly, S. J., et al. (2022). Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): A multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study. The Lancet, 399(10333), 1383–1390.
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