Table 3.
Safety Endpoints By Baseline Renal Function
|
High-dose Spironolactone GFR ≤50 (N=60) GFR 51-71 (N=55) GFR ≥72 (N=67) |
Usual Care GFR ≤50 (N=58) GFR 51-71 (N=65) GFR ≥72 (N=55) |
P value | Interaction P value | |
|---|---|---|---|---|
| Inpatient (i.e., study treatment phase) | ||||
| 96-h change in serum potassium (mEq/L) | 0.948 | |||
| GFR ≤50 | 0.10 (−0.10, 0.70) | 0.10 (−0.30, 0.60) | 0.582 | |
| GFR 51-71 | 0.40 (0.00, 0.70) | 0.20 (−0.30, 0.50) | 0.157 | |
| GFR ≥72 | 0.40 (0.00, 0.60) | 0.10 (−0.40, 0.80) | 0.316 | |
| 96-h change in serum creatinine (mg/dL) | 0.182 | |||
| GFR ≤50 | 0.20 (−0.10, 0.40) | 0.13 (−0.04, 0.41) | 0.777 | |
| GFR 51-71 | 0.20 (0.04, 0.46) | 0.04 (0.00, 0.30) | 0.133 | |
| GFR ≥72 | 0.00 (−0.09, 0.11) | 0.12 (−0.01,0.20) | 0.026 | |
| 96-h change in GFR (mL/min/1.732) | 0.033 | |||
| GFR ≤50 | −4.09 (−9.58, 3.96) | −4.74 (−10.10, 1.33) | 0.765 | |
| GFR 51-71 | −9.35 (−17.43, −1.88) | −1.58 (−13.55, 0.00) | 0.118 | |
| GFR ≥72 | 0.00 (−11.70, 13.01) | −10.05 (−19.16, 0.84) | 0.053 | |
| 30-day Adverse Event Rates | ||||
| Serious Adverse Event | 0.682 | |||
| GFR ≤50 | 11 (18.3) | 5 (8.6) | 0.123 | |
| GFR 51-71 | 4 (7.3) | 4 (6.2) | 1.000 | |
| GFR ≥72 | 6 (9.0) | 4 (7.3) | 1.000 | |
| Hyperkalemia ≥5.5 mEq/L | -- | |||
| GFR ≤50 | 1 (1.7) | 0 (0.0) | -- | |
| GFR 51-71 | 0 (0.0) | 1 (1.5) | -- | |
| GFR ≥72 | 0 (0.0) | 1 (1.8) | -- |
Data expressed as median (25th,75th). Data derived from patients with complete data for each endpoint (i.e., no imputation). Change refers to change in measure from baseline to 96-hours or hospital discharge, whichever occurred first.
GFR, estimated glomerular filtration rate