San Diego—Researchers, led by Patrick Rossignol, MD, PhD, recently conducted a post-hoc pooled analysis to examine the efficacy and safety of patiromer for the treatment of hyperkalemia in patients with and without diabetes mellitus. The researchers reported results of the analysis during a poster session at Kidney Week 2018 in a poster titledEfficacy and Safety of Patiromer in Participants with Diabetes: A Pooled Analysis.
Pooled data through week 4 from three trials of patiromer were analyzed. The data included participants who took more than one dose of patiromer and had more than one post-baseline serum potassium measurement. The participants were stratified based on the presence or absence of diabetes, and were assessed for (1) change in serum potassium from baseline at week 4, (2) serum potassium over time, and (3) percent with any serum potassium measurement in the target range of 3.8 to 5.0 mEq/L.
The analysis included 653 participants; 82% had diabetes; mean baseline hemoglobin A1c was 7.4%, and mean duration of diabetes was 14 years. In the patients with diabetes, mean baseline serum potassium was 5.4 mEq/L and estimated glomerular filtration rate (eGFR) was 40.3 mL/min/1.73 m2; in patients without diabetes the values were 5.5 mEq/L and 34.8 mL/min/1.73 m2, respectively.
At week 4, overall mean change from baseline in serum potassium was –0.72 in the diabetes group and –0.88 in participants without diabetes. Among participants with baseline serum potassium ≥5.5 mEq/L, mean serum potassium changes at week 4 were –1.01 in those with diabetes and –1.21 in those without diabetes. Among those with baseline serum potassium <5.5 mEq/L, the changes were –0.52 in participants with diabetes and –0.51 in participants without diabetes.
Regardless of serum potassium status at baseline, 95% of all participants in both the diabetes group and in the group without diabetes achieved any serum potassium measurement in the target range. The results were not impacted by the presence or absence of heart failure or eGFR <45 mL/min/1.73 m2.
At least one adverse event (AE) was reported by 31% of those with diabetes and 38% of those without diabetes. The most common AEs were constipation, diarrhea, hypomagnesemia, and nausea. Hypomagnesemia was reported in 2% of both groups. Lab values of magnesium of <1.4 mg/dL occurred in 5% of participants with diabetes and 1% of those without diabetes. Those who experienced low serum magnesium commonly used proton pump inhibitors and/or loop diuretics.
“In this post-hoc analysis of poled data, patiromer was equally effective and well-tolerated in [participants with and without diabetes],” the researchers said.
Source: Rossignol P, Gross C, Mayo M, et al. Efficacy and safety of patiromer in participants with diabetes: A pooled analysis. Abstract of a poster (FR-PO301) presented at the American Society of Nephrology Kidney Week 2018, October 26, 2018, San Diego, California.
This analysis was funded by Relypsa, Inc, a Vifor Pharma Group Company.