Table 3. Changes in outcome parameters after treatment with empagliflozin compared with placebo.
| Variable | Change in placebo period | Change in Empagliflozin period | Difference between changes (95% CI) | P-value |
|---|---|---|---|---|
| Clinical data | ||||
| Weight (kg) | 0.39 (1.79) | -2.45 (2.49) | 2.84 (1.47, 4.21) | <0.001 |
| Systolic BP (mmHg) | -6.42 (11.01) | -2.32 (14.02) | -4.11 (-11.51, 3.30) | 0.260 |
| Diastolic BP (mmHg) | -3.8 (6.18) | -1.2 (7.00) | -2.6 (-6.32, 1.16) | 0.164 |
| HR (beats/min) | -0.27 (8.84) | -2.11 (4.23) | 0.84 (-3.82, 5.49) | 0.709 |
| Echocardiographic measurements | ||||
| CFVR | 0.18 (0.60) | -0.16 (0.58) | 0.33 (0.23, 0.64) | 0.037 |
| CFV rest | 0.01 (0.06) | 0.00 (0.05) | 0.00 (-0.03, 0.04) | 0.778 |
| CFV hyperaemia | 0.05 (0.13) | -0.04 (0.15) | 0.09 (0.00, 0.18) | 0.044 |
| LVEF (%) | 1.2 (5.8) | 1.5 (5.6) | -0.2 (-4.85, 4.36) | 0.911 |
| Peak systolic strain (%) | -0.3 (1.3) | 0.2 (1.7) | -0.6 (-1.56, 0.45) | 0.259 |
| LVMI | -1.0 (9.6) | 0.4 (13.5) | -1.4 (-11.41, 8.57) | 0.769 |
| LAI | 0.9 (5.2) | -1.5 (4.0) | 2.4 (-0.03, 4.82) | 0.052 |
| E/e’ | 0.4 (3.3) | -0.4 (2.4) | 0.8 (-1.32, 2.93) | 0.439 |
| Laboratory data | ||||
| Hba1c (mmol/mol) | 0.8 (17.3) | -12.7 (10.4) | 13.5 (2.57, 24.48) | 0.018 |
| Creatinine (umol/L) | -0.6 (9.8) | 5.3 (5.5) | -5.9 (-11.43, -0.36) | 0.038 |
| Ketone rest* (mmol/L) | -0.11 (0.18) | 0.07 (0.16) | -0.18 (-0.30, -0.06) | 0.005 |
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.