TABLE 3.
Laboratory tests.
| Analysis set: FAS | Sacubitril/valsartan | Amlodipine | |||||||
|---|---|---|---|---|---|---|---|---|---|
| (N = 179) | (N = 176) | Between‐treatment difference | |||||||
| Biomarker | n | Geometric mean | Ratio of geometric mean and 95% CI b | n | Geometric mean | Ratio of geometric mean a and 95% CI b | Ratio of geometric mean c | 95% CI b | p value d |
| cGMP (nmol/mg·Cre) | |||||||||
| Baseline | 179 | 0.665 | — | 176 | 0.646 | — | — | — | — |
| Week 8 | 175 | 0.931 | 1.393 (1.317, 1.473) | 173 | 0.601 | 0.926 (0.875, 0.980) | 1.504 | (1.390, 1.627) | < 0.001 |
| ANP (pg/mL) | |||||||||
| Baseline | 179 | 18.19 | — | 176 | 16.80 | — | — | — | — |
| Week 8 | 175 | 39.06 | 2.14 (2.00, 2.30) | 173 | 14.65 | 0.87 (0.81, 0.93) | 2.46 | (2.24, 2.71) | < 0.001 |
| BNP (pg/mL) | |||||||||
| Baseline | 179 | 10.67 | — | 176 | 10.16 | — | — | — | — |
| Week 8 | 174 | 10.81 | 1.01 (0.94, 1.08) | 172 | 8.94 | 0.88 (0.82, 0.94) | 1.15 | (1.05, 1.27) | 0.003 |
| NT‐proBNP (pg/mL) | |||||||||
| Baseline | 179 | 51.12 | — | 176 | 54.22 | — | — | — | — |
| Week 8 | 174 | 34.36 | 0.67 (0.62, 0.73) | 172 | 34.76 | 0.64 (0.59, 0.70) | 1.05 | (0.93, 1.18) | 0.413 |
| UACR (mg/gCr) | |||||||||
| Baseline | 178 | 15.10 | — | 175 | 14.72 | — | — | — | — |
| Week 8 | 174 | 12.53 | 0.82 (0.73, 0.91) | 169 | 11.91 | 0.80 (0.73, 0.88) | 1.02 | (0.88, 1.18) | 0.781 |
| eGFR (mL/min/1.73 m2) | |||||||||
| Baseline | 179 | 70.348 | — | 176 | 71.667 | — | — | — | — |
| Week 8 | 175 | 70.618 | 1.003 (0.987, 1.019) | 173 | 74.193 | 1.033 (1.016, 1.050) | 0.971 | (0.949, 0.993) | 0.010 |
| Analysis set: SAS | Sacubitril/valsartan | Amlodipine | |||||||
|---|---|---|---|---|---|---|---|---|---|
| (N = 182) | (N = 177) | ||||||||
| Biochemistry | n | Arithmetic mean | Mean change and 95% CI | n | Arithmetic mean | Mean change and 95% CI | Mean difference | 95% CI | p value e |
| Sodium (mmol/L) | |||||||||
| Baseline | 182 | 141.9 | — | 177 | 141.7 | — | — | — | — |
| Week 8 | 175 | 141.8 | −0.1 (−0.4, 0.1) | 173 | 141.3 | −0.5 (−0.8, −0.2) | 0.4 | (0.0, 0.7) | 0.061 |
| Potassium (mmol/L) | |||||||||
| Baseline | 182 | 4.06 | — | 177 | 3.98 | — | — | — | — |
| Week 8 | 175 | 3.98 | −0.07 (−0.13, −002) | 173 | 3.84 | −0.15 (−0.20, −0.09) | 0.07 | (0.00, 0.15) | 0.049 |
| Creatinine (mg/dL) | |||||||||
| Baseline | 182 | 0.831 | — | 177 | 0.818 | — | — | — | — |
| Week 8 | 175 | 0.830 | −0.001 (−0.013, 0.011) | 173 | 0.791 | −0.024 (−0.036, −0.012) | 0.023 | (0.006, 0.040) | 0.007 |
| Uric acid (mg/dL) | |||||||||
| Baseline | 182 | 5.91 | — | 177 | 6.14 | — | — | — | — |
| Week 8 | 175 | 5.75 | −0.14 (−0.28, 0.00) | 173 | 5.75 | −0.38 (−0.50, −0.27) | 0.24 | (0.06, 0.43) | 0.009 |
Abbreviations: ANP, atrial natriuretic peptide; BNP, brain natriuretic peptide; cGMP, cyclic guanosine monophosphate; CI, confidence interval; eGFR, estimated glomerular filtration rate; FAS, full analysis set; NA, not applicable; NT‐proBNP, N‐terminal pro‐brain natriuretic peptide; SAS, safety analysis set; UACR, urine albumin‐to‐creatinine ratio.
The ratio of the geometric mean was calculated by dividing the geometric mean at Week 8 by that at baseline.
95% CI for the geometric mean.
The ratio of the geometric mean was calculated by dividing the geometric mean in sacubitril/valsartan by that in amlodipine.
p values were calculated by an independent t‐test with a two‐sided significance level of 0.05 for logarithmic values.
p values were calculated by an independent t‐test with a two‐sided significance level of 0.05.