Is patiromer sorbitex calcium (Veltassa) safe and effective in the treatment of hyperkalemia (high serum potassium level)?

Updated: Apr 09, 2020
  • Author: Eleanor Lederer, MD, FASN; Chief Editor: Vecihi Batuman, MD, FASN  more...
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Answer

FDA approval of patiromer was based on the AMETHYST-DN trial. Results showed that among patients with hyperkalemia and diabetic kidney disease taking RAAS inhibitors, patiromer resulted in statistically significant decreases in serum potassium level after 4 weeks of treatment, lasting through 52 week. [73]

The OPAL-HK trial showed that patiromer was well tolerated, decreased serum K(+) , and, compared with placebo, reduced recurrent hyperkalemia in patients with chronic kidney disease (CKD) and heart failure who were hyperkalemic while taking renin-angiotensin-aldosterone system inhibitors (RAASi). In the study, patiromer was given to patients with CKD who were taking RAASi and had serum K(+) levels >5.1 mEq/L to < 6.5 mEq/L (n=243) for 4 weeks. Patients whose K(+) levels were ≥3.8 mEq/L to < 5.1 mEq/L at the end of week 4 entered an 8-week randomized withdrawal phase and were randomly assigned to continue patiromer or switch to placebo. [74]

The primary efficacy endpoint was the between-group difference in median change in the serum K(+) over the first 4 weeks of the withdrawal phase. The median increase in serum K(+) from baseline of the withdrawal phase was greater with placebo (n = 22) than patiromer (n = 27) (P < 0.001). Recurrent hyperkalemia (serum K(+) ≥5.5 mEq/L) occurred in 52% of patients on placebo and 8% of those on patiromer (P < 0.001). [74]


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