Table 3.
Safety Summary.
| n (%) | Taking RAAS Inhibitors (n = 67) | Not taking RAAS Inhibitors (n = 46) | Total (N = 113) |
|---|---|---|---|
| With ≥1 AE | 26 (39) | 25 (54) | 51 (45) |
| Severity | |||
| Mild | 13 (19) | 13 (28) | 26 (23) |
| Moderate | 12 (18) | 10 (22) | 22 (19) |
| Severe | 1 (2) | 2 (4) | 3 (3) |
| Most common AEsa | |||
| Diarrhea | 1 (2) | 5 (11) | 6 (5) |
| Increased blood creatine phosphokinase | 2 (3) | 2 (4) | 4 (4) |
| Constipation | 1 (2) | 3 (7) | 4 (4) |
| Anemia | 0 | 3 (7) | 3 (3) |
| Headache | 0 | 3 (7) | 3 (3) |
| Urinary tract infection | 2 (3) | 1 (2) | 3 (3) |
| With ≥1 treatment-related AE | 7 (10) | 6 (13) | 13 (12) |
| Most common treatment-related AEsa | |||
| Diarrhea | 0 | 3 (7) | 3 (3) |
| Constipation | 1 (2) | 2 (4) | 3 (3) |
| With ≥1 AE leading to study discontinuation | 1 (2) | 2 (4) | 3 (3) |
| With ≥1 serious AEb | 2 (3) | 3 (7) | 5 (4) |
| Deaths | 0 | 1 (2) | 1 (<1) |
| Prespecified laboratory values of interest | |||
| Serum K+ <3.5 mEq/L | 0 | 0 | 0 |
| Serum Mg <1.2 mg/dLc | 0 | 0 | 0 |
| Serum Mg <1.4 mg/dLc | 2 (3) | 3 (7) | 5 (5) |
Abbreviations: AE, adverse event; K+, potassium; Mg, magnesium; RAAS, renin–angiotensin–aldosterone system.
a Occurring in ≥3 patients in the total group.
b None were considered related to patiromer in the judgment of the investigators.
c One patient had no postbaseline serum Mg value.