Table III.
Treatment‐Emergent Adverse Events Reported in >5% of Patients in Any Group
| Placebo (n=50) | Eplerenone 50 mg (n=49) | Eplerenone 100 mg (n=46) | Eplerenone 200 mg (n=48) | |||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event | n | % | n | % | n | % | n | % |
| Influenza‐like symptoms | 3 | 6.0 | 4 | 8.2 | 3 | 6.5 | 6 | 12.5 |
| AST increased | 1 | 2.0 | 2 | 4.1 | 0 | 0.0 | 4 | 8.3 |
| ALT increased | 0 | 0.0 | 3 | 6.1 | 0 | 0.0 | 4 | 8.3 |
| Eosinophilia | 0 | 0.0 | 1 | 2.0 | 1 | 2.2 | 4 | 8.3 |
| GGT increased | 0 | 0.0 | 1 | 2.0 | 2 | 4.3 | 3 | 6.3 |
| Back pain | 1 | 2.0 | 1 | 2.0 | 0 | 0.0 | 3 | 6.3 |
| Headache | 6 | 12.0 | 8 | 16.3 | 1 | 2.2 | 2 | 4.2 |
| Hypertriglyceridemia | 3 | 6.0 | 2 | 4.1 | 2 | 4.3 | 2 | 4.2 |
| Hyperuricemia | 1 | 2.0 | 3 | 6.1 | 3 | 6.5 | 2 | 4.2 |
| Pharyngitis | 1 | 2.0 | 2 | 4.1 | 3 | 6.5 | 2 | 4.2 |
| Malaise | 3 | 6.0 | 0 | 0.0 | 1 | 2.2 | 1 | 2.1 |
| Upper RTI | 3 | 6.0 | 2 | 4.1 | 1 | 2.2 | 1 | 2.1 |
| Lymphocytosis | 3 | 6.0 | 1 | 2.0 | 1 | 2.2 | 0 | 0.0 |
| Specific ECG abnormality | 3 | 6.0 | 0 | 0.0 | 1 | 2.2 | 0 | 0.0 |
| Hypertension aggravated | 3 | 6.0 | 2 | 4.1 | 0 | 0.0 | 0 | 0.0 |
| Peripheral pain | 3 | 6.0 | 0 | 0.0 | 0 | 0.0 | 0 | 0.0 |
| AST=aspartate transaminase; ALT=alanine transaminase; GGT=γ‐glutamyl transferase; RTI=respiratory tract infection; ECG=electrocardiogram | ||||||||