Welcome back to What’s it Worth! Join your hosts, Dr. Diana Langworthy and P4 Garrison Avery, as we discuss the RENAL-AF trial comparing apixaban vs warfarin in hemodialysis patients. These authors aimed to assess safety and efficacy in one of the first prospective trials comparing DOACs with warfarin in hemodialysis patients. Ever read a trial that didn't enroll their goal number of patients? Let's dig into patient recruitment considerations in trials and also pragmatic applications to medication selection, and properties of drugs that can be cleared by hemodialysis with real pharmacokinetic data to support!
Key Points
- The prevalence of atrial fibrillation in patients on hemodialysis has been noted to be as much as nine times higher than the general population
- Warfarin presents a challenge as an anticoagulant in patients on hemodialysis due a heightened risk of bleeding and risk for vascular complications such as calciphylaxis
- Studies that are published with neutral or negative findings can still provide important clinical context for understudied populations like patients on hemodialysis
- What does this underpowered trial tell us? ------> Tune in to find out!
References
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[EPISODE TRIAL] Pokorney SD, Chertow GM, Al-Khalidi HR, et al; RENAL-AF Investigators. Apixaban for Patients With Atrial Fibrillation on Hemodialysis: A Multicenter Randomized Controlled Trial. Circulation. 2022 Dec 6;146(23):1735-1745. doi: 10.1161/CIRCULATIONAHA.121.054990. Epub 2022 Nov 6. PMID: 36335914.
- Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int. 2024 Apr;105(4S):S117-S314. doi: 10.1016/j.kint.2023.10.018. PMID: 38490803.
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Joglar JA, Chung MK, Armbruster AL, et al. ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30. Erratum in: Circulation. 2024 Jan 2;149(1):e167. Erratum in: Circulation. 2024 Feb 27;149(9):e936. PMID: 38033089.
- What's behind racial disparities in kidney disease? 2021. Harvard Health Publishing; Harvard Medical School. Accessed on March 10, 2024: https://www.health.harvard.edu/blog/whats-behind-racial-disparities-in-kidney-disease-2021020321842#:~:text=The%20most%20recent%20report%20from,per%20million%20for%20white%20Americans.
- Mavrakanas TA, Samer CF, Nessim SJ, et al. Apixaban Pharmacokinetics at Steady State in Hemodialysis Patients. J Am Soc Nephrol. 2017 Jul;28(7):2241-2248. doi: 10.1681/ASN.2016090980. Epub 2017 Mar 16. PMID: 28302754; PMCID: PMC5491286.
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Dialysis. National Kidney Foundation [Web]. 30 East 33rd Street, New York, NY 10016 © 2024 National Kidney Foundation Inc. Dialysis - Types, effectiveness, side effects | National Kidney Foundation
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Vázquez, E., Vázquez-Sánchez, T. Sánchez-Perales, C. Letter by Vázquez et al Regarding Article, “Apixaban for Patients With Atrial Fibrillation on Hemodialysis: A Multicenter Randomized Controlled Trial” Circulation. 2023;148:378. DOI: 10.1161/CIRCULATIONAHA.122.063700 © 2023 American Heart Association, Inc.
Contact Information
Podcast email: whatsitworthpodcast@gmail.com
Host Information
Dr. Diana R. Langworthy, PharmD, BCPS
Clinical Associate Professor, University of Minnesota College of Pharmacy
Clinical Pharmacist - Inpatient Internal Medicine, M Health Fairview East Bank Hospital
Co-Host Information
Garrison (Griest) Avery, Student Pharmacist, Class of 2024
University of Minnesota College of Pharmacy
