Abstract: PO1456
Patient Palatability and Preference Study of Three Potassium Binders in Patients with CKD and Hyperkalemia: Rationale and Design of the APPETIZE Study
Session Information
- Fluid, Electrolyte, and Acid-Base Disorders: Clinical - 1
October 22, 2020 | Location: On-Demand
Abstract Time: 10:00 AM - 12:00 PM
Category: Fluid, Electrolyte, and Acid-Base Disorders
- 902 Fluid, Electrolyte, and Acid-Base Disorders: Clinical
Authors
- James, Glen, AstraZeneca PLC, Cambridge, Cambridgeshire, United Kingdom
- Søndergaard, Henning, Danish Kidney Association, Copenhagen, Denmark
- Moreno Quinn, Carol Patricia, AstraZeneca PLC, Cambridge, Cambridgeshire, United Kingdom
- Hedman, Katarina, AstraZeneca, Gothenburg, Sweden
- Karlsson, Niklas, AstraZeneca, Gothenburg, Sweden
- Hedberg, Jonatan, AstraZeneca, Gothenburg, Sweden
- Wittbrodt, Eric T., AstraZeneca, Gaithersburg, Maryland, United States
- Sabir, Ian, AstraZeneca PLC, Cambridge, Cambridgeshire, United Kingdom
- Tafesse, Eskinder, AstraZeneca, Gaithersburg, Maryland, United States
- Kim, Jennifer, AstraZeneca, Gaithersburg, Maryland, United States
- Allgren, Robin L., AstraZeneca, Gaithersburg, Maryland, United States
- Stjernlöf, Gunilla, AstraZeneca, Gothenburg, Sweden
- Någård, Mats, AstraZeneca, Gaithersburg, Maryland, United States
- Chung, Hui-Lan, AstraZeneca, Taipei, Taiwan
- Morris, Jon D., AdSAM, Gainesville, Florida, United States
- Fransson, Lars, AstraZeneca, Gothenburg, Sweden
- Rutgersson, Annika Ina, AstraZeneca, Gothenburg, Sweden
- Wheeler, David C., University College London, London, London, United Kingdom
Background
Patients with CKD are at risk of hyperkalemia (HK) which has been associated with a higher risk of cardiovascular events and mortality. Recently approved K+ binders provide new treatment options to fulfil the unmet need for HK treatment beyond traditional K+ binders, which are poorly tolerated by patients and are associated with GI side effects.
Methods
APPETIZE is a cross-sectional, randomised cross-over study with the aim to evaluate the palatability of and patient preference for 3 currently available K+ binders: Sodium Polystyrene Sulphonate (SPS) or Calcium Polystyrene Sulphonate (CPS), Sodium Zirconium Cyclosilicate (Lokelma®) and Calcium Patiromer Sorbitex (Veltassa®). A single (patient) blind side-by-side, sip and spit taste-test approach will be utilised where patients will be presented with a single full, per label dose of each product to replicate the real-world patient experience. Patient ratings, assessed on a 0-10 scale and emotional response using the AdSAM tool® to evaluate feelings (Appeal, Engagement and Empowerment) will be used to assess patient centric attributes: taste (primary outcome), texture, smell, mouthfeel and likelihood of adherence (secondary outcomes) of each product. Preferential ranking will be performed after all 3 products have been tested. Sixty CKD patients (both dialysis and non-dialysis) with HK per country (480 overall) from US, Canada, Spain, Italy, Germany, France, Sweden and Norway will be included, with equal proportions of patients ever-treated and never-treated with K+ binders.
Results
APPETIZE will describe, compare and rank palatability and preference of 3 currently available K+ binders by country. Initial results are anticipated towards end of 2020.
Conclusion
Utilizing innovative methodology, APPETIZE will generate evidence intended for patients and physicians (including nephrologists and cardiologists) regarding patient palatability, patient preference and predicted likelihood of adherence for currently available K+ binders.