Patiromer oral suspension, an investigational drug, was found to reduce elevated potassium levels in patients with chronic diabetic kidney disease. Findings from the study are published in the Journal of the American Medical Association.
The AMETHYST-DN trial, a Phase 2, multicenter study, enrolled 306 patients with hyperkalemia, hypertension, type 2 diabetes, and chronic kidney disease between June 2011–June 2013. Patients were assigned to 4.2g, 8.4g, 12.6g, or 16.8g twice daily based on the severity of their hyperkalemia.
Treatment with patiromer decreased serum potassium levels within 48 hours. Patients with mild hyperkalemia (5–5.5mmol/L) had a decrease of 0.35 with 4.2g twice daily, 0.5 with 8.4g twice daily, and 0.55 with 12.6g twice daily doses. Patients with moderate hyperkalemia (>5.5mmol/L) had greater improvement with 0.87 decrease with 8.4g twice daily, 0.97 with 12.6g twice daily, and 0.92 with 16.8g twice daily doses. Patients were maintained in the target range at each scheduled visit through Week 52.
A Phase 3 study was conducted in which patiromer showed consistent efficacy as was seen in the Phase study. Study authors from the University of Chicago Medicine concluded that findings support the long-term efficacy of patiromer.
Patiromer is a non-absorbed polymer that consists of smooth spherical beads about 1/10mm in diameter. When mixed with water and consumed, the particles attach to potassium ions in the lower colon and increase excretion of potassium in the stool. Previous research has demonstrated the efficacy of patiromer in treating hyperkalemia and other at-risk populations for durations of a few days up to 12 weeks.
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