Table 4.

Summary of SPS clinical studies for the treatment of hyperkalemia

Study design	Patient population	Primary end point(s)	Study treatment and duration	Major findings
Prospective observational study36	Patients with either acute or CKD and hyperkalemia (n=32)	Mean change in potassium concentration over 24 hours	SPS 20–60 g/day PO in four divided doses or 10–40 g rectally and repeated in 4–12 hours if necessary (dosage varied with the degree of hyperkalemia and the course of renal failure)	Mean potassium concentration reduction of –1.0 mEq/L in the PO group and –0.8 mEq/L in the rectal administration group
Prospective, randomized, single-blind clinical trial37	Patients with CKD (SCr >1.5 mg/dL) and hyperkalemia (>5.2 mEq/L) (n=97)	Mean change in potassium concentration over 3 days	SPS 5 g PO TID or CPS 5 g PO TID for 3 days	Mean ± SD baseline potassium 5.8±0.6 mEq/L in SPS group; potassium concentration decreased to 4.3±0.53 mEq/L by day 3
Prospective, randomized, double-blind, placebo-controlled clinical trial38	Outpatients with CKD (eGFR <40 mL/min/1.73 m2) and mild hyperkalemia (5–5.9 mEq/L) (n=33)	Mean change in potassium concentration from baseline to day 7	SPS 30 g PO once daily or placebo for 7 days	Mean potassium concentration reduction of –1.25±0.56 mEq/L in the SPS group compared to –0.21±0.29 mEq/L in the placebo group (mean difference –1.04 mEq/L, 95% CI –1.37 to –0.71 mEq/L; P<0.001)

Abbreviations: CI, confidence interval; CKD, chronic kidney disease; CPS, calcium polystyrene sulfonate; eGFR, estimated glomerular filtration rate; PO, per os (by mouth); SCr, serum creatinine; SD, standard deviation; SPS, sodium polystyrene sulfonate; TID, ter in die (three times daily).