Table 2.

Patients needing rescue therapy (full analysis set)

Study Perioda and Patients Requiring Rescue TherapybPatients, n (%)
SZC, n=97PBO, n=99Total, n=196
Treatment (overall)
 Patients requiring rescue therapy2 (2.1)5 (5.1)7 (3.6)
 Sodium polystyrene sulfonate0 (0.0)3 (3.0)3 (1.5)
 Calcium polystyrene sulfonate1 (1.0)1 (1.0)2 (1.0)
 Dialysis1 (1.0)1 (1.0)2 (1.0)
 Calcium gluconate1 (1.0)0 (0.0)1 (0.5)
 Insulin1 (1.0)1 (1.0)2 (1.0)
 Furosemide0 (0.0)1 (1.0)1 (0.5)
 Salbutamol0 (0.0)1 (1.0)1 (0.5)
Dose titration
 Patients requiring rescue therapy1 (1.0)5 (5.1)6 (3.1)
 Sodium polystyrene sulfonate0 (0.0)3 (3.0)3 (1.5)
 Dialysis1 (1.0)1 (1.0)2 (1.0)
 Calcium gluconate1 (1.0)0 (0.0)1 (0.5)
 Insulin1 (1.0)1 (1.0)2 (1.0)
 Calcium polystyrene sulfonate0 (0.0)1 (1.0)1 (0.5)
 Furosemide0 (0.0)1 (1.0)1 (0.5)
 Salbutamol0 (0.0)1 (1.0)1 (0.5)
Evaluation
 Patients requiring rescue therapy1 (1.0)1 (1.0)2 (1.0)
 Calcium polystyrene sulfonate1 (1.0)0 (0.0)1 (0.5)
 Sodium polystyrene sulfonate0 (0.0)1 (1.0)1 (0.5)
Follow-up
 Patients requiring rescue therapy0 (0.0)1 (1.0)1 (0.5)
 Calcium gluconate0 (0.0)1 (1.0)1 (0.5)
 Dialysis0 (0.0)1 (1.0)1 (0.5)
  • SZC, sodium zirconium cyclosilicate; PBO, placebo.

  • a Study period is defined using the date of the adverse event requiring rescue therapy.

  • b Rescue therapy was defined as any urgent therapeutic intervention considered necessary to reduce serum potassium (sK+) in the setting of severe hyperkalemia (defined by protocol as sK+>6.0 mmol/L). Use of rescue therapy was not strictly protocolized, and it was left to the investigator’s clinical judgment to be given in accordance with local practice patterns.