Trial reportJournal of diabetes investigation2026
Sodium zirconium cyclosilicate compared with potassium restriction for hyperkalemia management in type 2 diabetes: The SILVERSTAR trial.
Trial report in Journal of diabetes investigation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
16 authors.
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Abstract
AIMS/
introductionTo demonstrate noninferiority of continued sodium zirconium cyclosilicate therapy versus a potassium-restricted diet in achieving normokalemia at Visit 7 (Days 28-42) in individuals with type 2 diabetes and hyperkalemia, using a noninferiority margin of -10 percentage points (one-sided α = 0.025). MATERIALS AND
methodsThis multicenter, open-label, randomized trial assigned participants in the full analysis set to the sodium zirconium cyclosilicate (n = 37) or the diet group (n = 39) for the primary noninferiority analysis. Normokalemia was defined as serum potassium 3.5-<5.0 mEq/L at Visit 7.
resultsIn the full analysis set, normokalemia occurred in 28/36 (77.8%) and 26/38 (68.4%) patients in the sodium zirconium cyclosilicate and diet groups, respectively (risk difference +9.4 percentage points; 95% confidence interval, -11.1 to +29.8; one-sided P = 0.032), failing to demonstrate noninferiority. In the supportive per-protocol set, normokalemia occurred in 26/31 (83.9%) versus 17/24 (70.8%) patients, and the noninferiority criterion was met (P = 0.020); this analysis is exploratory. Mean serum potassium levels at Visit 7 were lower in the sodium zirconium cyclosilicate group (adjusted difference -0.23 mEq/L; 95% confidence interval, -0.42 to -0.03; P = 0.026). Dietary fiber intake decreased in the diet group. No changes in quality of life were observed between the two groups during the study period. The frequency of adverse events was low; however, one sudden death occurred in the sodium zirconium cyclosilicate group.
conclusionsThe trial did not meet its primary endpoint: noninferiority of sodium zirconium cyclosilicate to the potassium-restricted diet was not demonstrated in the full analysis set.
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