دورية أكاديمية
Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study.
| العنوان: | Randomised, blinded, cross-over evaluation of the palatability of and preference for different potassium binders in participants with chronic hyperkalaemia in the USA, Canada and Europe: the APPETIZE study. |
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| المؤلفون: | Wheeler DC; Department of Renal Medicine, Centre for Nephrology, University College London, London, UK d.wheeler@ucl.ac.uk., Søndergaard H; Danish Kidney Association, Taastrup, Denmark., Gwynn C; AdSAM, Gainesville, Florida, USA., Hedman K; BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Hedberg J; BioPharmaceuticals Medical Evidence and Observational Research, AstraZeneca, Gothenburg, Sweden., Allum A; UK Global Medical Affairs, AstraZeneca, Cambridge, UK., Chung HL; BioPharmaceuticals Medical Evidence, AstraZeneca, Taipei, Taiwan., Någård M; Clinical Pharmacology and Safety Sciences, AstraZeneca, Gaithersburg, Maryland, USA., Stjernlöf G; Global Patient Safety, AstraZeneca, Gothenburg, Sweden., Wittbrodt E; Global Medical Affairs, BioPharmaceuticals Medical, AstraZeneca, Gaithersburg, Maryland, USA., Kim J; Global Pricing and Market Access, AstraZeneca, Gaithersburg, Maryland, USA., Morris J; AdSAM, Gainesville, Florida, USA.; College of Journalism and Communications, University of Florida, Gainesville, Florida, USA. |
| المصدر: | BMJ open [BMJ Open] 2024 Feb 21; Vol. 14 (2), pp. e074954. Date of Electronic Publication: 2024 Feb 21. |
| نوع المنشور: | Clinical Trial, Phase IV; Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Hyperkalemia*/drug therapy , Hyperkalemia*/complications , Renal Insufficiency, Chronic*/complications , Silicates*, Humans ; Canada ; Cross-Over Studies ; Potassium ; Single-Blind Method |
| مستخلص: | Objectives: Traditional potassium (K + ) binders for treating hyperkalaemia are unpalatable and poorly tolerated. Newer K + binders are reportedly better tolerated; however, no published data describe their palatability, a determinant of long-term adherence. This study evaluated the palatability of and preference for three K + binders: sodium and calcium polystyrene sulfonate (S/CPS), sodium zirconium cyclosilicate (SZC) and calcium patiromer sorbitex (patiromer). Design: Phase 4, randomised, participant-blinded, cross-over study. Participants were randomised to one of six taste sequences and, using a 'sip and spit' approach, tasted each K + binder before completing a survey. Setting: 17 centres across the USA, Canada and European Union. Participants: 144 participants with chronic kidney disease, hyperkalaemia and no recent use of K + binders. Main Outcome Measures: For the primary (USA) and key secondary (Canada and European Union) endpoints, participants rated palatability attributes (taste, texture, smell and mouthfeel) and willingness to take each K + binder on a scale of 0-10 (rational evaluation). Feelings about each attribute, and the idea of taking the product once daily, were evaluated using a non-verbal, visual measure of emotional response. Finally, participants ranked the K + binders according to palatability. Results: In each region, SZC and patiromer outperformed S/CPS on overall palatability (a composite of taste, texture, smell and mouthfeel), based on rational evaluation and emotional response. Taking the product once daily was more appealing for SZC and patiromer, creating greater receptivity than the idea of taking S/CPS. The emotional response to mouthfeel had the strongest influence on feelings about taking each product. In each region, a numerically greater proportion of participants ranked SZC as the most preferred K + binder versus patiromer or S/CPS. Conclusions: Preference for more palatable K + binders such as SZC and patiromer may provide an opportunity to improve adherence to long-term treatment of hyperkalaemia. Trial Registration Number: NCT04566653. Competing Interests: Competing interests: DCW reports an ongoing consultancy contract with AstraZeneca and honoraria/speaker fees from Astellas, Bayer, Boehringer Ingelheim, George Clinical, GSK, Gilead, Janssen, Merck Sharp and Dohme, ProKidney, Tricida, Vifor and Zydus. HS has nothing to disclose. KH, JH, AA, H-LC, MN, GS, EW and JK are employees of and may hold stock in AstraZeneca. JM and CG are employees of AdSAM. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
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| فهرسة مساهمة: | Keywords: Chronic renal failure; Clinical Trial; Nephrology; Patient-Reported Outcome Measures |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04566653 |
| المشرفين على المادة: | RWP5GA015D (Potassium) 0 (Silicates) D652ZWF066 (sodium zirconium cyclosilicate) |
| تواريخ الأحداث: | Date Created: 20240222 Date Completed: 20240226 Latest Revision: 20240325 |
| رمز التحديث: | 20240325 |
| مُعرف محوري في PubMed: | PMC10882352 |
| DOI: | 10.1136/bmjopen-2023-074954 |
| PMID: | 38387989 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2023-074954 |