Table 3.
Changes in vital signs and biomarkers at 52 weeks in patients randomized to placebo and empagliflozin, according to baseline use of a neprilysin inhibitor
Patients not taking a neprilysin inhibitor (n = 3003) |
Patients taking a neprilysin inhibitor (n = 727) |
Interaction P-value | |||
---|---|---|---|---|---|
Placebo (n = 1480) | Empagliflozin (n = 1523) | Placebo (n = 387) | Empagliflozin (n = 340) | ||
Systolic blood pressure (mm Hg) | |||||
At 4 weeks | –1.7 ± 0.3 | –3.0 ± 0.3 | –1.4 ± 0.7 | –3.3 ± 0.7 | 0.59 |
–1.4 ± 0.5 (P = 0.005) | –1.9 ± 1.0 (P = 0.048) | ||||
At 52 weeks | –1.8 ± 0.5 | –2.4 ± 0.4 | –0.7 ± 0.9 | –2.1 ± 1.0 | 0.57 |
–0.6 ± 0.6 (P = 0.38) | –1.4 ± 1.3 (P = 0.29) | ||||
Bodyweight (kg) | +0.08 ± 0.15 | –0.71 ± 0.14 | +0.06 ± 0.29 | –0.81 ± 0.31 | 0.87 |
–0.80 ± 0.21 (P = 0.0001) | –0.87 ± 0.42 (P = 0.04) | ||||
Glycated haemoglobin (%) | –0.12 ± 0.05 | –0.30 ± 0.05 | –0.11 ± 0.09 | –0.21 ± 0.10 | 0.65 |
–0.18 ± 0.07 (P = 0.0074) | –0.11 ± 0.14 (P = 0.44) | ||||
Uric acid (mg/mL) | –0.01 ± 0.05 | –0.92 ± 0.05 | –0.18 ± 0.09 | –1.17 ± 0.10 | 0.59 |
–0.91 ± 0.07 (P < 0.0001) | –0.99 ± 0.14 (P < 0.0001) | ||||
NT-proBNP (ratio of geometric means) | 0.85 (0.81–0.90) | 0.74 (0.71–0.78) | 0.87 (0.79–0.96) | 0.77 (0.69–0.85) | 0.88 |
0.87 (0.81–0.93) P < 0.0001 | 0.88 (0.76–1.02) P = 0.09 | ||||
Haematocrit (%) | –0.26 ± 0.11 | +2.04 ± 0.11 | –0.86 ± 0.22 | +1.69 ± 0.24 | 0.49 |
+2.29 ± 0.16, P < 0.0001 | +2.55 ± 0.33, P < 0.0001 |
For all variables except for NT-proBNP, changes are shown as adjusted mean ± standard error. Because of the exceptional non-normal distribution, changes in NT-proBNP are shown as the ratio of geometric means and 95% confidence intervals. Changes in glycated haemoglobin were measured in patients with diabetes, i.e. 735 placebo-treated patients and 765 empagliflozin-treated patients among those not receiving a neprilysin inhibitor at baseline and in 194 placebo-treated patients and 162 empagliflozin-treated patients among those receiving a neprilysin inhibitor at baseline.
NT-proBNP, N-terminal prohormone B-type natriuretic peptide.