Sodium zirconium cyclosilicate

(Lokelma®)

Lokelma®

Drug updated on 9/4/2024

Dosage FormSuspension (oral; 5 g, 10 g)
Drug ClassPotassium binders
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of hyperkalemia in adults.

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Summary
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  • Lokelma (sodium zirconium cyclosilicate) is indicated for the treatment of hyperkalemia in adults.
  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • New potassium binders (NPBs) were associated with improved RAASi therapy optimization, with a relative risk (RR) of 1.13 (95% CI: 1.02-1.25, P=0.02) and reduced instances of patients receiving suboptimal MRA doses (RR: 0.72, 95% CI: 0.57-0.90, P=0.004). Potassium binders also increased RAASi use with an RR of 1.14 (95% CI: 1.02-1.28, P=0.021).
  • NPBs significantly reduced the risk of hyperkalemia, with RR values ranging from 0.42 (95% CI: 0.24-0.72, P=0.002) to 0.66 (95% CI: 0.52-0.84, P<0.001), and decreased hyperkalemia events by 29% (95% CI: 55-92%).
  • Sodium zirconium cyclosilicate (SZC) effectively reduced serum potassium levels (mean reduction: -0.42 mmol/L, 95% CI: -0.63 to -0.20, P=0.0001) and significantly increased the proportion of patients achieving normokalemia (RR 3.48, 95% CI 1.49-8.11, P=0.004).
  • New potassium binders (NPBs) were generally well-tolerated but were associated with an increased risk of hypokalemia (RR: 1.57, 95% CI: 1.12-2.21, P=0.009) and an increased risk of edema with SZC (RR 4.30, 95% CI 1.17-15.84, P=0.03).
  • Older potassium binders, particularly sodium polystyrene sulfonate (SPS), were associated with more severe gastrointestinal adverse effects, such as colonic necrosis, hypomagnesemia, and hypernatremia, compared to newer binders like patiromer and SZC, which may cause fewer gastrointestinal side effects.
  • Potassium binders were effective in optimizing RAASi therapy and reducing hyperkalemia in specific subgroups, including heart failure patients, chronic kidney disease patients, patients using RAAS inhibitors, and those with diabetes, with noted risks of hypokalemia, edema with SZC, and gastrointestinal adverse effects more prominent with older binders.

Product Monograph / Prescribing Information

Document TitleYearSource
Lokelma (sodium zirconium cyclosilicate) Prescribing Information.2024AstraZeneca Pharmaceuticals LP, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
The efficacy and safety of new potassium binders on renin-angiotensin-aldosterone system inhibitor optimization in heart failure patients: a systematic review and meta-analysis.2024ESC Heart Failure
Safety and efficacy of new potassium binders on hyperkalemia management in patients with heart failure: a systematic review and meta-analysis of randomized controlled trials.2023Clinical Research in Cardiology
Novel potassium binders to optimize RAASi therapy in heart failure: A systematic review and meta-analysis. 2023European Journal of Internal Medicine
Therapeutic update on oral potassium exchange resin use in chronic kidney disease patients: a systematic review of randomized controlled clinical trials.2023Journal of Pharmacy & Pharmaceutical Sciences
Efficacy and safety of potassium binders in the treatment of patients with chronic kidney disease and hyperkalemia. 2022European Journal of Pharmacology
Effects and safety of a novel oral potassium-lowering drug-sodium zirconium cyclosilicate for the treatment of hyperkalemia: a systematic review and meta-analysis.2021Cardiovascular Drugs and Therapy
Binding potassium to improve treatment with renin-angiotensin-aldosterone system inhibitors: Results from multiple one-stage pairwise and network meta-analyses of clinical trials.2021Frontiers in Medicine
Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.2020The Cochrane Database of Systematic Reviews
Efficacy and safety of the pharmacotherapy used in the management of hyperkalemia: a systematic review.2019Pharmacy Practice

Clinical Practice Guidelines