Table 2. Changes in outcome parameters after treatment with empagliflozin and placebo.
| Variable | Placebo period, value before (mean, SD) | Placebo period, value after (mean, SD) | P value | Empaglifozin period, value before (mean, SD) | Empagliflozin period, value after (mean, SD) | P value |
|---|---|---|---|---|---|---|
| Clinical data | ||||||
| Weight (kg) | 94.3 (26.8) | 94.7 (26.3) | 0.350 | 95.0 (26.7) | 92.6 (26.0) | <0.001 |
| Systolic BP (mmHg) | 134.8 (17.2) | 128.3 (14.1) | 0.021 | 131.9 (18.6) | 129.6 (18.2) | 0.481 |
| Diastolic BP (mmHg) | 76.2 (9.5) | 72.4 (10.0) | 0.016 | 75.7 (8.8) | 74.5 (9.7) | 0.461 |
| HR (beat/min) | 72 (10) | 70 (9) | 0.550 | 71 (8) | 69 (9) | 0.071 |
| Echocardiographic measurements | ||||||
| CFVR | 2.53 (0.63) | 2.70 (0.77) | 0.217 | 2.61(0.59) | 2.45 (0.75) | 0.250 |
| CFV rest (m/s) | 0.24 (0.06) | 0.25 (0.07) | 0.576 | 0.23 (0.06) | 0.23 (0.05) | 0.766 |
| CFV hyperaemia (m/s) | 0.60 (0.15) | 0.65 (0.16) | 0.092 | 0.59 (0.16) | 0.55 (0.13) | 0.284 |
| LVEF (%) | 58 (6) | 60 (5) | 0.360 | 57 (5) | 58 (5) | 0.256 |
| Peak systolic strain (%) | 18.2 (3.0) | 17.9 (2.7) | 0.252 | 17.5 (2.9) | 17.7 (2.6) | 0.589 |
| LVMI | 82.2 (19.9) | 81.1 (20.8) | 0.656 | 77.2 (19.0) | 77.6 (18.5) | 0.895 |
| LAI | 26.0 (5.1) | 26.9 (5.1) | 0.469 | 26.3 (5.2) | 24.8 (6.3) | 0.115 |
| E/e’ | 10.0 (2.3) | 10.4 (3.6) | 0.578 | 9.9 (3.7) | 9.5 (2.7) | 0.507 |
| Laboratory data | ||||||
| Hba1c (mmol/mol) | 70.4 (16.7) | 71.3 (11.5) | 0.834 | 72.7 (12.5) | 60.0 (11.9) | <0.001 |
| Creatinine (umol/L) | 73.1 (19.1) | 72.5 (19.3) | 0.782 | 71.6 (19.4) | 76.9 (20.6) | <0.001 |
| Ketone rest* (mmol/L) | 0.25 (0.20) | 0.14 (0.11) | 0.012 | 0.20 (0.17) | 0.27 (0.14) | 0.073 |
BP: Blood Pressure, HR: Heart Rate, CFVR: Coronary Flow Velocity Reserve, CFV: Coronary Flow Velocity, LVEF: Left Ventricular Ejection Fraction, LVMI: Left Ventricular Mass Index, LAI: Left Atrial Index.
*significant carry-over effect.