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LOKELMA® (sodium zirconium cyclosilicate) is indicated for the treatment of hyperkalaemia in adult patients.
NICE TA599 has been updated (now TA1148) to expand the recommendation for LOKELMA (sodium zirconium cyclosilicate) to be used as an option to treat persistent hyperkalaemia in eligible chronic kidney disease (CKD) or heart failure (HF) patients with serum K+ ≥5.5mmol/L, while also providing greater flexibility across care settings, allowing treatment initiation in both primary and secondary care.1,2
Please see the full NICE recommendation below.*
*NICE TA1148 guidance states sodium zirconium cyclosilicate is recommended as an option for treating persistent hyperkalaemia in adults if used:
This lowered threshold for initiating K+ binders brings NICE guidance into closer alignment with ESC and KDIGO – all of which now recommend starting treatment at serum potassium levels of ≥5.0–5.5mmol/L. This supports earlier management of hyperkalaemia and helps maintain optimised RAASi therapy.2-4
This NICE expansion has primarily been driven by real-world evidence:
SPARK is a real-world observational study in ~630K eligible CKD or HF patients in the UK, specifically designed to directly evaluate the relationship between serum K+ and adverse outcomes. The study was designed in line with the NICE RWE framework.†,5,6
The IRR estimate was adjusted for baseline characteristics, including age, sex, comorbidities, and other covariates.5
Graph adapted from AstraZeneca SPARK study. Data on file Sept 2025.
Serum potassium category (mmol/L)
†SPARK was a retrospective observational study using data from the Clinical Practice Research Datalink (CPRD), linked to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) mortality data (2004–2021). Patients with an index serum potassium measurement (2016–2019) and evidence of hyperkalaemia or potassium binder use in CPRD were included.5,6
ZORA is a real-world observational cohort study that assesses the odds of continuing RAASi therapy at 6 months in patients with CKD and/or HF experiencing hyperkalaemia, comparing those treated with LOKELMA to those receiving no K+binder.‡,7
Findings from ZORA real-world evidence are consistent with the randomised controlled trials used to establish the LOKELMA Summary of Product Characteristics.1,7
‡The study, funded by AstraZeneca, was an observational, cohort study programme performed using secondary data extracted from health registers and hospital medical records from the US, Spain and Japan. The primary outcome of the ZORA analysis conducted by Rastogi et al. (2024) was the proportion of patients who maintained RAASi therapy at 180 days post-index. The objective of the additional subgroup analysis of ZORA was to determine the proportions of patients discontinuing or down-titrating RAASi therapy stratified by recorded S–K levels (≥5.0–<5.5mmol/L, ≥5.5–<6.0mmol/L, and ≥6.0mmol/L). Based on nominal significance level of p=0.05.7,8
Worsening of pre-existing heart failure during treatment was reported as a very common adverse reaction where most cases were resolved with appropriate clinical management without withdrawing LOKELMA. The commonly reported adverse reactions were hypokalaemia, oedema-related events and constipation.1
Patients with pre-existing heart failure, particularly those in whom an increased sodium intake may lead to fluid overload and decompensation, should monitored for manifestations of worsening heart failure. These may include increased dyspnoea, oedema and rapid weight gain, and should be managed as per standard clinical practice.1
For full details of adverse events reported, interactions or pharmacodynamic effects please consult Summary of Product Characteristics.1
CKD, Chronic Kidney Disease; CPRD, Clinical Practice Research Datalink; ESC, European Society of Cardiology; HF, Heart Failure; HES, Hospital Episode Statistics; K+, Potassium; KDIGO, Kidney Disease: Improving Global Outcomes; MACE, Major Adverse Cardiovascular Events; mmol/L, Millimoles per litre; NICE, National Institute for Health and Care Excellence; ONS, Office for National Statistics; RAASi, Renin–Angiotensin–Aldosterone System inhibitors; TAG, Technology Appraisal Guidance.
GB-76091 | DOP: May 2026
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
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