Welcome back to What’s it Worth! Join your host, Dr. Diana Langworthy and returning co-host Dr. Meade Avery (2025 U of MN CoP Grad!!) as we PrEPare our clinical conclusions about a novel antiviral for HIV prevention. We also welcome an HIV expert, Dr. Daniel (Jude) Holt, who is a clinical pharmacist at North Memorial Health in the Infectious Diseases clinic.  The study we critique compares twice yearly lenacapavir with daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) in cisgender women for HIV prevention (PrEP).  

Key Points

1. HIV prevention is a critical step in the fight to end HIV
2. There are many barriers to compliance with daily oral HIV preventative medications including access and compliance
3. Twice yearly lenacapavir has been proven effective at preventing HIV in men who have sex with men and transgender women, but was yet to be studied in cisgender women
4. A twice yearly regimen can help patients overcome barriers to compliance
5. Will we find out "Where's "Wald"-o in our Stat Stop? ------> Tune in to find out!

References

1. [EPISODE TRIAL] Bekker LG, Das M, Abdool Karim Q, et al.  Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women. NEJM 2024;391(13):1179-1192.

2. Kelley CF, Acevedo-Quinones M, Agwu AL, et al.  Twice yearly lenacapavir for HIV prevention in men and gender-diverse persons. NEJM 2024;392(13):1261-1276.

3. Bekerman E, Hansen D, Lu B, et al. Long-acting capsid inhibitor effective as PrEP against vaginal SHIV transmission in macaques. In: Proceedings and Abstracts of the 11th IAS Conference on HIV Science, July 18–21, 2021. Virtual: International AIDS Society, 2021. abstract.

4. Centers for Disease Control and Prevention. "HIV Prevention Research Synthesis Project." HIV Compendium of Best Practices. October 24, 2024, June 6, 2025, https://www.cdc.gov/hivpartners/php/hiv-treatment/index.htmlnters for Disease Control and Prevention

Contact Information

Podcast email: [email protected]

Expert Guest

Dr. Daniel (Jude) Holt, PharmD, AAHIVP, CSP

Clinical Pharmacy Specialist - Infectious Disease

Specialty Pharmacy Infectious Disease Support

[email protected]

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

Meade Avery, PharmD

2025 Graduate, University of Minnesota College of Pharmacy

Welcome back to What’s it Worth! Join your hosts, Dr. Diana Langworthy and Dr. Peyton Braun (PGY1 Pharmacy Resident), as we sift through strengths and limitations of at trial assessing the effects of empagliflozin on nonalcoholic fatty liver disease.  The authors sought to quantify the impact of Sodium Glucose Cotransporter 2 - inhibitors (SGLT2i's) on Metabolic Dysfunction Associated Liver Disease (MASLD).  This episode is full of EBP detective moments - dissecting trial language to get a clear picture of the story. Let's dive in and see what its worth!  

Key Points

1. MASLD is a condition marked by an accumulation of fat in the liver which can lead to inflammation and irreversible liver damage
2. MASLD is often associated with conditions such as obesity, diabetes and hypertension 
3. SGLT2i's are an evidence based therapy for the treatment of type II diabetes and have also shown to improve outcomes in heart failure and kidney disease
4. Extraglycemic benefits of this class of agents are of particular interest, with an increasing number of clinical trials investigating their potential impact on a variety of diseases (including MASLD)
5. Does a trial conducted with non-probability sampling have enough internal validity for empagliflozin in MASLD? ------> Tune in to find out!

References

1. [EPISODE TRIAL] Shojaei, F., Erfanifar, A., Kalbasi, S. et al. The effect of empagliflozin on non-alcoholic fatty liver disease-related parameters in patients with type 2 diabetes mellitus: a randomized controlled trial. BMC Endocr Disord 25, 52 (2025). https://doi.org/10.1186/s12902-025-01882-8

2. Zhang Y, Liu X, Zhang H, Wang X. Efficacy and safety of empagliflozin on nonalcoholic fatty liver disease: a systematic review and meta-analysis. Front Endocrinol 2022; doi: 10.3389/fendo.2022.836455

3. Rinella, Mary E.1; Neuschwander-Tetri, Brent A.2; Siddiqui, Mohammad Shadab3; Abdelmalek, Manal F.4; Caldwell, Stephen5; Barb, Diana6; Kleiner, David E.7; Loomba, Rohit8. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology 77(5):p 1797-1835, May 2023. | DOI: 10.1097/HEP.0000000000000323

4. Kanwal, Fasiha1,2,3; Neuschwander-Tetri, Brent A.4; Loomba, Rohit5; Rinella, Mary E.6. Metabolic dysfunction–associated steatotic liver disease: Update and impact of new nomenclature on the American Association for the Study of Liver Diseases practice guidance on nonalcoholic fatty liver disease. Hepatology 79(5):p 1212-1219, May 2024. | DOI: 10.1097/HEP.0000000000000670

5. Chen, Vincent L.1; Morgan, Timothy R.2,3; Rotman, Yaron4; Patton, Heather M.5,6; Cusi, Kenneth7; Kanwal, Fasiha8,9,10; Kim, W. Ray11. Resmetirom therapy for metabolic dysfunction-associated steatotic liver disease: October 2024 updates to AASLD Practice Guidance. Hepatology 81(1):p 312-320, January 2025. | DOI: 10.1097/HEP.0000000000001112
6. Stratton SJ. Purposeful Sampling: Advantages and Pitfalls. Prehospital and Disaster Medicine. 2024;39(2):121-122. doi:10.1017/S1049023X24000281

Contact Information

Podcast email: [email protected]

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

Peyton Braun, PGY1 Pharmacy Resident

University of Minnesota Medical Center - East Bank

Welcome back to What’s it Worth! Join your hosts, Dr. Diana Langworthy and Dr. Garrison Avery (PGY1 Pharmacy Resident), as we discuss the STOP ACEi trial comparing continuation of ACEi/ARB (angiotensin converting enzyme inhibitors/angiotensin receptor blockers) therapy in ESKD vs discontinuation of ACEi/ARB therapy. The authors sought to answer the question - Does discontinuation vs continuation of ACEi/ARB therapy slow the decline in eGFR once someone progresses to Stage 4/5 CKD.  Let's get into the weeds of baseline characteristics - follow the episode's breadcrumbs to see if you can spot the key unmeasured confounders in this publication!  

Key Points

1. ACEi/ARB therapy has demonstrated proven benefit in slowing the progression of CKD when initiated in Stages 1-3
2. Robust evidence is lacking to guide continuation vs discontinuation of ACEi/ARB therapy once a patient progresses to Stage 4/5 CKD
3. Compound symmetry covariance structures can be a useful statistical tool when the change between study visits in the key measurements is not anticipated to vary greatly (confused? So were we! Listen in for an explanation.)
4. What baseline characteristics might impact the primary outcome that may not have been accounted for? ------> Tune in to find out!

References

1. [EPISODE TRIAL] Bhandari S, Mehta S, Khwaja A, et al.  Renin-Angiotensin System Inhibition in Advanced Chronic Kidney Disease. The STOP ACEi Trial. NEJM 2022;387:2021-2032.

2. 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.

3. Delgado C, Baweja M, Crews, D, et al.  A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. JASN 2021;32(1@):2994-3015

4. Xie X, Liu Y, Perkovic V, et al.  Renin-Angiotensin System Inhibitors and Kidney and Cardiovascular Outcomes in Patients with CKD: A Bayesian Network Meta-analysis of Randomized Clinical Trials. AJKD 2016;67(5):728-741.

5. DynaMed. Chronic Kidney Disease (CKD) in Adults. EBSCO Information Services. Accessed May 19, 2025. https://www-dynamed-com.ezp3.lib.umn.edu/condition/chronic-kidney-disease-ckd-in-adults-1

Contact Information

Podcast email: [email protected]

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, PGY1 Pharmacy Resident

University of Minnesota Medical Center - East Bank

Episode 2 of the Double Header with the Minnesota Twins! The first article, the SEQUOIA trial, was discussed in the preceding episode with Mckay Carstens... did you guess correctly for which twin was speaking? He's passing the baton to his brother Kane to discuss management of portal hypertension in patients with cirrhosis. We're looking back in time with a retrospective study that investigated whether carvedilol showed more effectiveness compared with classical NSBBs to prevent decompensation in patients with cirrhosis. Stick with us to see if the weight of portal hypertension is lifted in this cohort and explore the role of selection bias in retrospective cohort studies.

Key Points

1. Cirrhosis is a leading cause of liver-related morbidity worldwide and managing complications like portal hypertension is key to improving outcomes
2. Progression to decompensated cirrhosis—marked by ascites, variceal bleeding, or encephalopathy—reduces median survival to approximately 2 years thus highlighting the importance of prevention of decompensating events.
3. Carvedilol has gained attention for its added alpha-1 blockade, offering greater portal pressure reduction—though its long-term benefits and safety compared to traditional NSBBs remain under investigation
4. Get curious about selection bias - can we confidently interpret and apply these trial results? ------> Tune in to find out!

References

1. [EPISODE TRIAL] Fortea JI, Alvarado-Tapias E, Simbrunner B, et al. Carvedilol vs. propranolol for the prevention of decompensation and mortality in patients with compensated and decompensated cirrhosis. Journal of Hepatology 2025; https://doi.org/10.1016/j.jhep.2024.12.017.

2. Kaplan DE, Ripoll C, Thiele M, et al.  AASLD Practice Guidelines on risk stratification and management of portal hypertension and varices in cirrhosis. Hepatology 2024;79:1180-1211.
3. Turco L, Reiberger T, Vitale G, La Mura V. Carvedilol as the new non-selective beta-blocker of choice in patients with cirrhosis and portal hypertension. Liver International 2023;43(6):1183-1194.
4. Villanueva C, Torres F, Kumar Sarin S, et al.  Carvedilol reduces the risk of decompensation and mortality in patients with compensated cirrhosis in a competing-risk meta-analysis. Journal of Hepatology 2022;77(4):1014-1025.
5. Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Statistics in Medicine 2015;34(28);3661-3679.

Contact Information

Podcast email: [email protected]

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

Kane Carstens, PharmD

PGY1 Resident, University of Minnesota Medical Center East Bank

Mckay Carstens, PharmD

PGY1 Resident, University of Minnesota Medical Center East Bank

Join us for a Double Header with the Minnesota Twins! No, we haven't converted to a sports podcast... I have PGY1 Residents (who are identical twins), Kane and Mckay Carstens joining me for back-to-back journal critiques! The first article, the SEQUOIA trial, was conducted to determine the efficacy and safety of aficamten, a novel cardiac myosin inhibitor, in patients with obstructive Hypertrophic Cardiomyopathy (HoCM).  Let's get into the weeds to see the forest for the trees - what is aficamten's possible place in therapy for HoCM?

Key Points

1. Hypertrophic Cardiomyopathy (HCM) is one of the most common genetic heart conditions worldwide
2. Historical pharmacologic treatments are aimed at symptom resolution, but there have not been agents that directly target the mechanism of disease
3. Cardiac myosin inhibitors are a new class of drugs on the block with promise for patients with HoCM
4. But what do hierarchical secondary outcomes tell us? ------> Tune in to find out!

References

1. [EPISODE TRIAL] Maron MS, Masri A, Nassif ME, et al.  Aficamten for symptomatic obstructive hypertrophic cardiomyopathy [SEQUOIA-HCM]. NEJM 2024;390:1849-1861.

2. Maron BJ. Clinical course and management of hypertrophic cardiomyopathy. NEJM 2018.379:655-668.
3. Ommen SR, Ho CY, Asif IM, et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR Guideline for the Management of Hypertrophic Cardiomyopathy: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation 2024;149:e1239-e1311.
4. Laporte S, Divine M, Girault D, et al. What usage and what hierarchical order for secondary endpoints? Therapie 2016,71(1):35-41.

CPR Certification Links

American Heart Association CPR & First Aid: https://cpr.heart.org/en/course-catalog-search

HeartCert: https://heartcertcpr.com/

Contact Information

Podcast email: [email protected]

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

Kane Carstens, PharmD

PGY1 Resident, University of Minnesota Medical Center East Bank

Mckay Carstens, PharmD

PGY1 Resident, University of Minnesota Medical Center East Bank

Welcome to What’s it Worth! Join your host, Dr. Diana Langworthy and student guest host, Meade Avery, as we walk the tightrope of anticoagulation in elderly patients with Atrial Fibrillation (AFib). We'll be reviewing an article that evaluated frail, elderly patients with AFib and compared maintaining INR guided warfarin with switching to a direct acting oral anticoagulant (DOAC). Come along as we decide To Stay or Not To Stay with VKAs!

Key Points

1. Atrial fibrillation leads to an increased risk of stroke/systemic embolism (SSE) and maintenance anticoagulation is indicated for patients at elevated risk
2. Guidelines recommend DOACs as first line for prevention of SSE in AFib patients however there is little data to determine whether frail elderly patients are better left on their INR guided warfarin
3. Pragmatic, or real-world, studies can be helpful in special populations that are often excluded from key randomized controlled trials however may be limited by unmeasured confounders 
4. Should more elderly patients stay on their INR guided warfarin? --> Tune in to find out!

CHA₂DS₂-VASc Score for Atrial Fibrillation Stroke Risk Calculator: https://www.mdcalc.com/calc/801/cha2ds2-vasc-score-atrial-fibrillation-stroke-risk

Contact Information

Podcast email: [email protected]

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

Guest Host Information

Meade Avery, Student Pharmacist 

Class of 2025 - University of Minnesota College of Pharmacy

References

1. [EPISODE TRIAL] Joosten, L. P. T., van Doorn, S., van de Ven, P. M., Köhlen, B. T. G., Nierman, M. C., Koek, H. L., Hemels, M. E. W., Huisman, M. V., Kruip, M., Faber, L. M., Wiersma, N. M., Buding, W. F., Fijnheer, R., Adriaansen, H. J., Roes, K. C., Hoes, A. W., Rutten, F. H., & Geersing, G. J. (2024). Safety of Switching From a Vitamin K Antagonist to a Non-Vitamin K Antagonist Oral Anticoagulant in Frail Older Patients With Atrial Fibrillation: Results of the FRAIL-AF Randomized Controlled Trial. Circulation, 149(4), 279–289. https://doi.org/10.1161/CIRCULATIONAHA.123.066485
2. McMahan, D. A., Smith, D. M., Carey, M. A., & Zhou, X. H. (1998). Risk of major hemorrhage for outpatients treated with warfarin. Journal of general internal medicine, 13(5), 311–316. https://doi.org/10.1046/j.1525-1497.1998.00096.x
3. Joglar, J. A., Chung, M. K., Armbruster, A. L., Benjamin, E. J., Chyou, J. Y., Cronin, E. M., Deswal, A., Eckhardt, L. L., Goldberger, Z. D., Gopinathannair, R., Gorenek, B., Hess, P. L., Hlatky, M., Hogan, G., Ibeh, C., Indik, J. H., Kido, K., Kusumoto, F., Link, M. S., Linta, K. T., … Peer Review Committee Members (2024). 2023 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, 149(1), e1–e156. https://doi.org/10.1161/CIR.0000000000001193 
4. Saviano, A., Brigida, M., Petruzziello, C., Candelli, M., Gabrielli, M., & Ojetti, V. (2022). Gastrointestinal Bleeding Due to NOACs Use: Exploring the Molecular Mechanisms. International journal of molecular sciences, 23(22), 13955. https://doi.org/10.3390/ijms232213955
5. Konicki R, Weiner D, Patterson JH, et al.  Rivaroxaban precision dosing strategy for real-world atrial fibrillation patients. Clin Transl Sci 2020;13(4):777-784.
6. Mueck W, Lensing AW, Agnelli G, et al.  Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention. Clin Pharmacokinet 2011;50(10):675-686.
7. Garcia, D. A., Lopes, R. D., & Hylek, E. M. (2010). New-onset atrial fibrillation and warfarin initiation: high risk periods and implications for new antithrombotic drugs. Thrombosis and haemostasis, 104(6), 1099–1105. https://doi.org/10.1160/TH10-07-0491 
8. Healthiest Countries 2024. World Population Review. (n.d.). https://worldpopulationreview.com/country-rankings/healthiest-countries. Accessed September 17, 2024.

Welcome to What’s it Worth! Join your host Dr. Diana Langworthy, with student co-host Rachel Cohen, as we hit the design dictionary to decode statistical language and simplify estimands and populations. Our expert guest for this episode is Dr. Kylee Funk, Assoiate Professor and Ambulatory Care Pharmacist. We're discussing a trial that compared oral semaglutide with subcutanous liraglutide, GLP-1 agonists, for the treatment of type 2 diabetes.

Key Points

1. Non-inferiority (NI) trials are indicated when there are other effective treatment options or where it would be unethical to expose a group to placebo
2. NI margins are important components to critique when reviewing these trials to determine clinical implications and whether the margin is clinically justifiable 
3. Populations, like Intent to Treat, can sometimes be categorized as Estimands
4. How can I describe Estimands and GLP1 Effectiveness to my preceptor? --> Tune in to find out!

References

1. [EPISODE TRIAL] Pratley R, Amod A, Hoff ST, et al.  Oral semaglutide versus subcutaneous liraglutide and placebo in type 2 diabetes (PIONEER 4): a randomised, double-blind, phase 3a trial. The Lancet 2019;394:39-50.
2. Davies M, Pieber TR,  Hartoft-Nielsen ML, et al.  Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes: a randomized clinical trial. JAMA 2017; 318:1460-1470.
3. Karagiannis T, Avgerinos I, Liakos A, et al.  Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Diabetologia 2022;65(8): 1251-1261.

Contact Information

Podcast email: [email protected]

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

Rachel Cohen, Student Pharmacist, Class of 2025  University of Minnesota

Guest Host Information

Dr. Kylee Funk, PharmD, BCACP

Associate Professor, Pharmaceutical Care and Health Systems

Ambulatory Care Pharmacist

University of Minnesota College of Pharmacy

Welcome to What’s it Worth! Join your host Dr. Diana Langworthy as we record live with our 2nd year Pharmacy Students for their EBP Pulse Check! We're exploring whether or not we should REDUCE our use of beta blockers in post MI patients who have a preserved ejection fraction by critiquing the REDUCE-AMI trial (NEJM 2024). Our expert guest for this episode is Dr. Anne Schullo-Feulner, Clinical Professor at the University of Minnesota College of Pharmacy and Cardiology Clinical Specialist at Methodist Hospital in St. Louis Park, MN. We discuss key concepts related to interpretation of results and how we can leverage our biostatistics knowledge to tackle Kaplan Meier Curves!

Special shout out to our PD2 Student Participants in the podcast: Andrew Gabbitas, Natalie Pearson, and Emma Maudal!

Key Points

1. The majority of evidence to support beta blocker use post-MI comes from the pre-reperfusion era
2. The REDUCE-AMI Trial aimed to determine whether or not patients with preserved ejection fraction after AMI should receive a beta blocker 
3. Comparison of baseline characteristics from clinical trials to characteristics of your patient population is critical to determine generalizability of data to your practice 
4. What are some hidden gems within these Kaplan Meier Curves? --> Tune in to find out!

References

1. [EPISODE TRIAL] Yndigegn T, Lindahl B, Mars K, et al. Beta-blockers after myocardial infarction and preserved ejection fraction. [REDUCE-AMI] NEJM 2024;390:1372-1381.
2. Virani SS, Newby K, Arnold SV, et al.  2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Manatement of Patients with Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation 2023;148(9):e9-e119.
3. Lewis GD, Gosch K, Cohen LP. Effect of dapagliflozin on 6-minute walk distance in heart failure with preserved ejection fraction: PRESERVED-HF. Circ Heart Fail 2023;16(11):e010633.

Contact Information

Podcast email: [email protected]

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

Guest Host Information

Dr. Anne Schullo-Feulner, PharmD, BCPS

Clinical Professor, University of Minnesota College of Pharmacy

Clinical Pharmacist - Cardiology, Methodist Hospital

Welcome to What’s it Worth! Join your host Dr. Diana Langworthy and guest host Rachel Cohen (PharmD Candidate, 2025) as we take a look at how cannabis affects pregnancy outcomes.  Our guest, Dr. Ann Philbrick, PharmD, BCACP, will share her expertise with the current state of cannabis use and what it looks like to see patients who use cannabis in pregnancy.

Key Points

1. Existing evidence regarding cannabis in pregnancy has focused primarily on neonatal/fetal outcomes leaving a gap in maternal outcomes

2. Discussions about the safety of cannabis are more common as more states begin to legalize medical and recreational use

3. This is odd... Odds Ratio and Relative Risk can be similar but are not the same thing - when should we expect to see each of these? 

4. Cannabis use in pregnancy was linked to increased maternal risk, however retrospective cohorts can present opportunity for unmeasured confounders---> TUNE IN to find out what those might be!

References

1. [EPISODE TRIAL] Young-Wolff KC, Adams SR, Alexeeff SE, et al. Prenatal Cannabis Use and Maternal Pregnancy Outcomes. JAMA Intern Med. Published online July 22, 2024. doi:10.1001/jamainternmed.2024.3270

2. Lo JO, Shaw B, Robalino S, et al. Cannabis Use in Pregnancy and Neonatal Outcomes: A Systematic Review and Meta-Analysis. Cannabis Cannabinoid Res. 2024;9(2):470-485. doi:10.1089/can.2022.0262

3. Baía I, Domingues RMSM. The Effects of Cannabis Use during Pregnancy on Low Birth Weight and Preterm Birth: A Systematic Review and Meta-analysis. Am J Perinatol. 2024;41(1):17-30. doi:10.1055/a-1911-3326 

Contact Information

Podcast email: [email protected]

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

Guest Host Information

Rachel Cohen, Student Pharmacist, Class of 2025  University of Minnesota

Guest Expert

Dr. Ann Philbrick, PharmD, BCACP, Associate Professor, University of Minnesota College of Pharmacy

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

1. The prevalence of atrial fibrillation in patients on hemodialysis has been noted to be as much as nine times higher than the general population
2. 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
3. Studies that are published with neutral or negative findings can still provide important clinical context for understudied populations like patients on hemodialysis
4. What does this underpowered trial tell us? ------> Tune in to find out!

References

1. [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.

2. 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.

3. 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.

4. 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.
5. 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.

6. 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

7. 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: [email protected]

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