What's it Worth? A Journal Club Podcast

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: whatsitworthpodcast@gmail.com [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 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: whatsitworthpodcast@gmail.com [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 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: 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 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 [https://www.kidney.org/atoz/content/dialysisinfo] 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: whatsitworthpodcast@gmail.com [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

Welcome back to What’s it Worth! Join your hosts, Dr. Diana Langworthy and Garrison Avery, student PharmD, as we evaluate the 52 week reported outcomes of the ongoing Resmetirom Phase 3 trial. This trial is our first look at a medication currently seeking FDA approval to halt and reverse NASH and liver fibrosis. We also discuss Bonferroni statistical analysis, patients excluded from the trial, and bias in language.    Key Points 1. The FDA accelerated approval process might get your pharmacist-spidey senses going, but is it a concern? 2. Non-alcoholic steatohepatitis (NASH) is the most severe form of non-alcoholic fatty liver disease (NAFLD) and can progress to end stage liver disease if not managed properly 3. Recognizing when manuscript language may be suggestive of an effect (when one has not been statistically proven) is important to keep top of mind when critiquing an article. 4. Is there promise for patients with NAFLD to take their livers back in time? --> Tune in to find out! References 1. [EPISODE TRIAL] Harrison SA, Bedossa P, Guy CD, et al; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000. PMID: 38324483. 2. Kanwal F, Neuschwander-Tetri BA, Loomba R, Rinella ME.  Metabolic dysfunction-associated steatotic liver disease: Update and impact of new nomenclature on the American Association for the Study of Liver Diseases practice fuidance on nonalcoholic fatty liver disease. Hepatology 2023;DOI: 10.1097/HEP.0000000000000670. 3. Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, et al.  AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease Hepatology 2023;77(5):1797-1835. 4. U.S. Food and Drug Administration. Accelerated Approval Program. Accessed March 8, 2024. https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program Contact Information Podcast email: whatsitworthpodcast@gmail.com [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