S1E5 - Seeing composite outcomes CLEAR-ly: Bempedoic acid versus placebo for preventing Major Adverse Cardiovascular Outcomes
What's it Worth? A Journal Club Podcast
Release Date: 07/05/2023
S2E3 (#14) - Can I Have Some More Power Please? Apixaban vs Warfarin for AFib in Hemodialysis
What's it Worth? A Journal Club Podcast
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...
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S2E2 (#13) - What's the Brass Tacks on MAESTRO-NASH?
What's it Worth? A Journal Club Podcast
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 The FDA accelerated approval process might get your pharmacist-spidey senses going, but is it a concern? Non-alcoholic steatohepatitis (NASH) is the...
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S2E1 (#12) - Beating Benzos? Phenobarbital versus benzodiazepines in severe alcohol withdrawal syndrome.
What's it Worth? A Journal Club Podcast
Did you miss us? We're back for Season 2 of What’s it Worth! Join your host, Dr. Diana Langworthy, and co-host Garrison (Griest) Avery (back at the end of his APPE year for some more EBP fun!), as they find out if phenobarbital is beating benzos in severe alcohol withdrawal! CI-WAt all the fuss is about in season two as we PAWSS and reflect on where single-site retrospective results and clinical takeaways can meet! Key Points Alcohol withdrawal syndrome is a complex process involving acute imbalances in excitatory and inhibitory neurotransmitters in the CNS that can predispose...
info_outline![[BONUS] S1E11 - Pegfilgrastim Equivalence Chronicles: Is The Margin Razor Thin? show art](https://assets.libsyn.com/item/28742148?height=50&width=50)
[BONUS] S1E11 - Pegfilgrastim Equivalence Chronicles: Is The Margin Razor Thin?
What's it Worth? A Journal Club Podcast
Welcome to What’s it Worth - BONUS episode #2! Join your host Dr. Diana Langworthy and a come-back by P4 student co-host Marina Fahim as we get biosimilar! Our expert guest for this episode is Dr. Hannah Berg, Formulary Management Pharmacist at United Healthcare. We're discussing a trial that aimed to determine whether pegfilgrastim biosimilars were considered statistically equivalent to the pegfilgrastim originator product. Biosimilars have the potential to offer cost-savings for patients requiring these expensive agents as they can introduce market competition and a potentially...
info_outline![[BONUS] S1E10 - The Scoop on Poop! Fecal Microbiota Therapy for Reducing Recurrence of CDiff Infections show art](https://assets.libsyn.com/item/28739793?height=50&width=50)
[BONUS] S1E10 - The Scoop on Poop! Fecal Microbiota Therapy for Reducing Recurrence of CDiff Infections
What's it Worth? A Journal Club Podcast
Welcome to What’s it Worth - a BONUS episode! Join your host Dr. Diana Langworthy and a come-back by P4 student co-host Garrison Griest as we get the scoop on poop! Our expert guest for this episode is Dr. Jen Ross, Antimicrobial Stewardship Clinical Pharmacist at M Health Fairview East and West Bank Hospitals. We're discussing a trial that evaluated the efficacy of a new orally administered fecal microbiota transplant capsule - SER-109. This episode coincides with a Journal Club assignment that students in my Evidence Based Practice course completed last week - Hello PHAR6782...
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S1E9 - Co-Primary Clues: Zavegepant's Journey in Migraine Management
What's it Worth? A Journal Club Podcast
Welcome to What’s it Worth! Join your host Dr. Diana Langworthy as we co-mingle with co-primary clues! Our expert guest for this episode is Dr. Natalie Heinrich, Medication Therapy Management Clinical Pharmacist in Neurology at M Health Fairview. We're discussing a trial evaluated the efficacy of zavegepant, a novel CGRP antagonist for nasal administration, for the treatment of acute migraine attack. Join us as we discuss the key points of co-primary outcomes, populations and power. Key Points Migraine disease affects 1 in 6 Americans and is a leading cause of disability...
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S1E8 - ATTACK-ing Non-Inferiority Trials and Margins: Sulbactam-Durlobactam for Acinetobacter Infections
What's it Worth? A Journal Club Podcast
Welcome to What’s it Worth! Join your host Dr. Diana Langworthy, & co-host Marina Fahim, as we ATTACK the critique of a non-inferiotiy study design. Our expert guest for this episode is Dr. Betsy Hirsch, Assoiate Professor and Infectious Diseases Translational Researcher. We're discussing a trial that compared a new beta-lactam antibiotic, sulbactam/durlobactam, with colistin for the treatment of Acinetobacter baumannii infections. Join us as we discuss the key points of a non-inferiority trial design as we determine what this article is worth! Key Points Non-inferiority...
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S1E7 - Breaking Down Delphi: A qualitative implementation study on clinical pharmacist impact
What's it Worth? A Journal Club Podcast
Welcome to What’s it Worth! Join your host, Dr. Diana Langworthy and co-host Chelsea Bolier, PharmD, as we break down Delphi and learn more about analyzing qualitatitve data. We're joined this month by Dr. Joel Farley, PhD and Dr. Pamela Phelps, PharmD, FASHP - two experts in the arena of determining the impact of clinical pharmacy services. Key Points Determining the impact of clinical pharmacist interventions is a complex and site specific process The Delphi (or modified Delphi) process is intended for use to answer a qualitative research question...
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S1E6 - Going Retro to Tackle Confounding: Assessing Risk of SBP from PPI use in Cirrhosis
What's it Worth? A Journal Club Podcast
Welcome to What’s it Worth! Join your hosts, Dr. Diana Langworthy & Garrison Griest as we go retro to tackle confounding variables! We'll be reviewing an article that aimed to determine the risk of spontaneous bacterial peritonitis (SBP) in patients with cirrhosis who are using proton pump inhibitors (PPIs). Key Points Retrospective studies produce more opportunities for confounding variables to impact study results Proton pump inhibitors are widely used and overused for acid reflux disease and have been associated with several risks Odds ratios calculated for retrospective...
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S1E5 - Seeing composite outcomes CLEAR-ly: Bempedoic acid versus placebo for preventing Major Adverse Cardiovascular Outcomes
What's it Worth? A Journal Club Podcast
08Welcome to What’s it Worth! Join your hosts, Dr. Diana Langworthy, Nathan Uk, and Garrison Griest as we walk you through composite outcomes with the CLEAR trial - a comparison of bempedoic acid versus placebo for preventing major adverse cardiovascular events (MACE) in patients who cannot tolerate statin therapy. We're joined by Dr. Chrystian Pereira, PharmD, BCACP, an ambulatory care pharmacist at the Smiley's Family Medicine Clinic in South Minneapolis, MN. Key Points Statins play a key role in prevention of major cardiovascular events (MACE), yet not all...
info_outline08Welcome to What’s it Worth! Join your hosts, Dr. Diana Langworthy, Nathan Uk, and Garrison Griest as we walk you through composite outcomes with the CLEAR trial - a comparison of bempedoic acid versus placebo for preventing major adverse cardiovascular events (MACE) in patients who cannot tolerate statin therapy. We're joined by Dr. Chrystian Pereira, PharmD, BCACP, an ambulatory care pharmacist at the Smiley's Family Medicine Clinic in South Minneapolis, MN.
Key Points
- Statins play a key role in prevention of major cardiovascular events (MACE), yet not all patients tolerate them
- Bempedoic acid may have a place in therapy to prevent MACE for patients who cannot tolerate statins
- Composite outcomes involve > 1 outcome and they should be of similar clinical severity
- Learning your POEMs and DOEs of a trial help you critique evidence that matters --> Tune in to learn more about what POEMs and DOEs are!
References
- [EPISODE TRIAL] Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. NEJM 2023; DOI: 10.1056/NEJMoa2215024.
- Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. Circulation 2019;139(25):e1082-e1143.
- Bytyci I, Penson PE, Mikhailidis DP, et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J 2022;43:3213-23.
- Shaikh A, Ochani RK, Khan MS, et al. Contribution of individual components to composite end points in contemporary cardiovascular randomized controlled trials. Am Heart J 2020;230:71-81.
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
Garrison Griest, Student Pharmacist, Class of 2025 University of Minnesota
Nathan Uk, Student Pharmacist, Class of 2025 University of Minnesota
Guest Expert
Dr. Chrystian Pereira, PharmD, BCACP, Associate Professor, University of Minnesota College of Pharmacy