Drug updated on 9/4/2024
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
- Veltassa (patiromer) is indicated for the treatment of hyperkalemia in adults and pediatric patients aged 12 years and older.
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- New potassium binders (NPBs), including patiromer, significantly improved mineralocorticoid receptor antagonist (MRA) therapy optimization in heart failure patients, with a risk ratio (RR) of 1.13 (95% CI 1.02-1.25, P=0.02) and a 14% improvement in RAASi therapy optimization (95% CI 4-26%).
- Patiromer reduced the incidence of hyperkalemia by 58% (RR 0.42, 95% CI 0.24-0.72, P=0.002) and showed a mean serum potassium reduction of -0.71 mEq/L after 4 weeks.
- Sodium zirconium cyclosilicate (SZC) was more effective in achieving normokalemia than patiromer, with a SUCRA ranking >0.78 compared to >0.58 for patiromer.
- Patiromer reduced serum potassium levels similarly in patients with and without heart failure and demonstrated greater efficacy in severe/end-stage CKD, with a reduction of -0.84 mEq/L compared to -0.60 mEq/L in mild/moderate CKD.
- Hypokalemia Risk: Patiromer and other new potassium binders were associated with an increased incidence of hypokalemia, with relative risks of 1.57 (95% CI 1.12-2.21, P=0.009) and 1.51 (95% CI 1.07-2.12) reported in different studies.
- Adverse Events: Common adverse events related to patiromer included gastrointestinal disorders, such as constipation (8% in severe CKD, 3% in mild/moderate CKD) and diarrhea (4% in severe CKD, 2% in mild/moderate CKD). There were no serious adverse events considered related to the drug.
- Subgroup Differences: Patients with heart failure experienced a higher rate of adverse events leading to discontinuation of patiromer (7%) compared to those without heart failure (3%).
- The evidence focuses on specific populations, particularly heart failure and chronic kidney disease (CKD) patients, highlighting that patiromer effectively reduces hyperkalemia and optimizes RAASi therapy across these groups. Subgroup analysis indicated that in heart failure patients, patiromer was associated with increased hypokalemia risk, while in CKD patients, efficacy was consistent across stages, with gastrointestinal symptoms being the most common adverse events. Sodium zirconium cyclosilicate (SZC) was noted for higher normokalemia efficacy but increased edema compared to patiromer.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Veltassa (patiromer) Prescribing Information. | 2023 | CSL Vifor, Flughofstrasse, Glattbrugg, Switzerland |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Clinical Practice Guidelines: treatment of acute hyperkalaemia in adults. | 2020 | The Renal Association |