Drug updated on 10/31/2024
Dosage Form | Suspension (oral; 8.4 g, 16.8 g, 25.2 g) |
Drug Class | Potassium binders |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of hyperkalemia in adults and pediatric patients ages 12 years and older.
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Summary
- This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
- Reduction of Serum Potassium in CKD (chronic kidney disease) and Heart Failure: Patiromer effectively reduced serum potassium, with a mean decrease of -0.84 ± 0.03 mEq/L in severe/end-stage CKD patients and -0.60 ± 0.04 mEq/L in mild/moderate CKD. It lowered hyperkalemia risk in heart failure by 44% (RR (relative risk) 0.56, 95% CI (confidence interval) 0.36-0.87) and achieved normokalemia levels in clinical assessments (SUCRA (surface under the cumulative ranking area) >0.58).
- Support for RAASi Therapy Optimization in Heart Failure: Patiromer and other NPBs (new potassium binders) were associated with a higher rate of reaching MRA target doses (RR 1.13, 95% CI 1.02-1.25) and a reduction in RAASi (renin-angiotensin-aldosterone system inhibitors) discontinuations due to hyperkalemia (RR 0.49, 95% CI 0.25-0.98), supporting sustained RAASi therapy in heart failure management.
- Comparative Efficacy with Other Potassium Binders: Sodium zirconium cyclosilicate (SZC) demonstrated superior efficacy over patiromer in achieving normokalemia (SUCRA >0.78 vs. >0.58 for patiromer), while calcium polystyrene sulfonate showed limited effect compared to sodium polystyrene sulfonate on serum potassium (MD 0.38 mEq/L, 95% CI -0.03 to 0.79).
- Increased Hypokalemia Risk with Patiromer and Other NPBs: Patiromer was associated with an elevated risk of hypokalemia, with a relative risk of 1.51 (95% CI 1.07-2.12), and NPBs overall showed an increased hypokalemia incidence (RR 1.57, 95% CI 1.12-2.21; P = 0.009).
- Adverse Events in CKD Subgroups: In severe/end-stage CKD, adverse events related to patiromer occurred in 16% of patients, leading to a 6% discontinuation rate, while in mild/moderate CKD, related AEs occurred in 12%, with a 2% discontinuation rate. Common AEs included mild-to-moderate constipation (8% in severe, 3% in mild CKD) and diarrhea (4% in severe, 2% in mild CKD).
- Patients included in the studies were adults with chronic kidney disease (CKD), specifically nondialysis CKD stratified by severity (severe/end-stage and mild/moderate CKD), and individuals with heart failure receiving guideline-directed medical therapy (GDMT), often using renin-angiotensin-aldosterone system inhibitors (RAASi) or mineralocorticoid receptor antagonists (MRAs). Patiromer was effective in reducing serum potassium across CKD stages and supported RAASi optimization in heart failure management.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Veltassa (patiromer) Prescribing Information. | 2023 | Vifor Pharma Ltd., Redwood City, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical Practice Guidelines: treatment of acute hyperkalaemia in adults | 2020 | The Renal Association |