Table 3.
Number of patients, % | Patiromer treatment group |
Total (n = 113) | |
---|---|---|---|
without food (n = 57) | with food (n = 56) | ||
Patients with ≥1 AEs | 24 (42.1) | 27 (48.2) | 51 (45.1) |
Most common AEs* | |||
Diarrhea | 3 (5.3) | 3 (5.4) | 6 (5.3) |
Increased creatine phosphokinase | 1 (1.8) | 3 (5.4) | 4 (3.5) |
Constipation | 2 (3.5) | 2 (3.6) | 4 (3.5) |
Anemia | 3 (5.3) | 0 (0) | 3 (2.7) |
Headache | 0 (0) | 3 (5.4) | 3 (2.7) |
Urinary tract infection | 1 (1.8) | 2 (3.6) | 3 (2.7) |
Patients with ≥1 treatment-related AEs | 6 (10.5) | 7 (12.5) | 13 (11.5) |
Most common treatment-related AEs* | |||
Diarrhea | 1 (1.8) | 2 (3.6) | 3 (2.7) |
Constipation | 2 (3.5) | 1 (1.8) | 3 (2.7) |
Discontinuations due to AEs | 2 (3.5) | 1 (1.8) | 3 (2.7) |
Patients with ≥1 serious AEs† | 4 (7.0) | 1 (1.8) | 5 (4.4) |
Deaths† | 1 (1.8) | 0 | 1 (0.9) |
Prespecified laboratory values of interest | |||
Serum K+ <3.5 mEq/L | 0 (0) | 0 (0) | 0 (0) |
Serum Mg2+ <1.4 mg/dL‡ | 3 (5.4) | 2 (3.6) | 5 (4.5) |
AEs, adverse events; K+, potassium; Mg2+, magnesium.
Occurring in 3 or more patients overall.
None considered related to patiromer in the judgment of the investigator.
Mg2+ levels were 1.2–1.3 mg/dL and not accompanied by symptoms.