Table 2.
Summary of adverse events
| Adverse events, n (%) | Esaxerenone | |
|---|---|---|
| Monotherapy (n = 33) | Add-on therapy (n = 58) | |
| All adverse events | 21 (63.6) | 35 (60.3) |
| Serious adverse events | 0 (0.0) | 0 (0.0) |
| Drug-related treatment-emergent adverse events | 8 (24.2) | 17 (29.3) |
| Discontinued due to treatment-emergent adverse eventsa | 2 (6.1) | 1 (1.7) |
| Adverse events (n ≥2 in either study) | ||
| Influenza | – | 2 (3.4) |
| Nasopharyngitis | 3 (9.1) | – |
| Viral upper respiratory tract infection | – | 7 (12.1) |
| Constipation | 2 (6.1) | – |
| Diarrhea | 1 (3.0) | 2 (3.4) |
| Dizziness | – | 2 (3.4) |
| Head discomfort | – | 2 (3.4) |
| Blood creatinine increased | – | 3 (5.2) |
| Blood potassium increased | 1 (3.0) | 6 (10.3) |
| Blood urea increased | – | 2 (3.4) |
| Blood uric acid increased | 2 (6.1) | 3 (5.2) |
| Hematuria | 2 (6.1) | – |
| eGFR decreased | 1 (3.0) | 3 (5.2) |
| Arthropod sting | 3 (9.1) | – |
| Change in serum K+ level | ||
| Serum K+ ≥5.5 mEq/L | 0 (0.0) | 7 (12.1) |
| Serum K+ ≥6.0 mEq/L or ≥5.5 mEq/L on two consecutive occasions | 0 (0.0) | 0 (0.0) |
eGFR estimated glomerular filtration rate
aIn monotherapy, two patients discontinued due to adverse events, one experienced altered consciousness and the other had chest pain, and the first event was judged to be related to the study drug. In add-on therapy, one patient discontinued due to mild abnormal hepatic function that was judged to be related to the study drug and returned to the normal range after the study drug was discontinued