Table 3.
Change in creatinine, estimated glomerular filtration rate, sodium, and potassium by treatment arm over trial follow‐up
| Vericiguat mean (SE) | Placebo mean (SE) | Difference estimatea(95% CI) | SliceP‐valueb | InteractionP‐valuec | |
|---|---|---|---|---|---|
| Creatinine | 0.18 | ||||
| Baseline | 1.31 (0.012) | 1.30 (0.011) | – | ||
| Week 16 | 1.36 (0.014) | 1.32 (0.012) | 0.026 (0.004 to 0.047) | 0.018 | |
| Week 32 | 1.37 (0.015) | 1.34 (0.014) | 0.021 (−0.006 to 0.049) | 0.13 | |
| Week 48 | 1.36 (0.016) | 1.37 (0.017) | 0.002 (−0.027 to 0.032) | 0.88 | |
| eGFR | 0.50 | ||||
| Baseline | 61.82 (0.572) | 62.47 (0.569) | – | ||
| Week 16 | 60.42 (0.585) | 61.99 (0.598) | −1.013 (−1.900 to −0.126) | 0.025 | |
| Week 32 | 59.84 (0.598) | 61.35 (0.617) | −0.816 (−1.785 to 0.153) | 0.10 | |
| Week 48 | 60.26 (0.686) | 60.42 (0.698) | −0.400 (−1.494 to 0.695) | 0.47 | |
| Sodium | 0.045 | ||||
| Baseline | 139.97 (0.073) | 139.92 (0.071) | – | ||
| Week 16 | 140.09 (0.071) | 140.00 (0.072) | 0.055 (−0.117 to 0.226) | 0.53 | |
| Week 32 | 140.09 (0.072) | 140.20 (0.070) | −0.092 (−0.266 to 0.081) | 0.30 | |
| Week 48 | 140.19 (0.080) | 140.08 (0.077) | 0.153 (−0.037 to 0.343) | 0.11 | |
| Potassium | 0.68 | ||||
| Baseline | 4.49 (0.011) | 4.51 (0.011) | – | ||
| Week 16 | 4.44 (0.012) | 4.48 (0.011) | −0.025 (−0.054 to 0.003) | 0.08 | |
| Week 32 | 4.46 (0.012) | 4.50 (0.012) | −0.031 (−0.061 to −0.001) | 0.043 | |
| Week 48 | 4.48 (0.013) | 4.50 (0.013) | −0.015 (−0.048 to 0.019) | 0.39 |
CI, confidence interval; eGFR, estimated glomerular filtration rate; SE, standard error.
a
Estimate obtained from a mixed model fit with treatment, time, their interaction and the baseline lab value.
b
Slice P‐value is for the comparison of vericiguat to placebo at each time point.
c
Interaction P‐value for the interaction between treatment and time.