
S2E6 (#17) - Decoding Estimands and GLP-1 Agonist Effectiveness in the PIONEER 4 Study
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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
- 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
- NI margins are important components to critique when reviewing these trials to determine clinical implications and whether the margin is clinically justifiable
- Populations, like Intent to Treat, can sometimes be categorized as Estimands
- How can I describe Estimands and GLP1 Effectiveness to my preceptor? --> Tune in to find out!
References
- [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.
- 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.
- 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
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