CHICAGO—Long-term treatment of hyperkalemia with sodium zirconium cyclosilicate has no clinically significant impact on blood pressure, researchers reported in a poster presented at the American Society of Nephrology’s 2016 Kidney Week meeting.
The conclusion is based on the findings of an ongoing 12-month multicenter prospective phase 3 trial designed to evaluate the long-term safety and efficacy of sodium zirconium cyclosilicate, an investigational non-absorbed compound that selective exchanges potassium for hydrogen and sodium throughout the gastrointestinal tract. Of the 751 adult patients with hyperkalemia enrolled in the trial, 436 completed 6 or more months, 287 completed 9 or more months, and 155 completed 12 months of sodium zirconium cyclosilicate treatment as of December 7, 2015, a research team led by Pablo E. Pergola, MD, of Renal Associates PA in San Antonio, Texas, reported. At baseline, 82.6% of patients had hypertension and 34.4% had heart failure. In addition, 73.6% of patients had chronic kidney disease (estimated glomerular filtration rate below 60 mL/min/1.73 m2).
Results showed that 746 (99.3%) of the 751 patients achieved normal potassium levels within 48 hours of initiating 10 g sodium zirconium cyclosilicate 3 times daily (induction phase) and entered the maintenance phase of the trial. In the overall patient population, mean serum potassium levels declined significantly from 5.6 mEq/L at baseline of the induction phase to 4.7 mEq/L at the start of the maintenance phase, Dr Pergola and his colleagues reported.
The investigators said they observed no clinically meaningful changes in mean systolic and diastolic blood pressure over time among all treated patients or among the 155 patients who completed 12 months of treatment.
Two patients (0.3%) experienced mild de novo hypertension during the study, and the investigators did not consider this to be drug-related.
The most common gastrointestinal events were constipation, nausea, diarrhea, and vomiting, which occurred in 5.0%, 4.3%, 3.5%, and 2.9% of patients, respectively, Dr Pergola and his collaborators reported.
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- Pergola PE, Spinowitz B, McCullough PA, et al. Effect of sodium zirconium cyclosilicate treatment for hyperkalemia on blood pressure in a long-term, open-label phase 3 study. Poster presented at the 2016 Kidney Week meeting in Chicago, Nov. 15-20. Poster TH-PO478.