Table 1.
Primary and key secondary outcomes
| Outcome | Dapagliflozin (n = 28), mean (SD) | Placebo (n = 28), mean (SD) | Adjusted treatment effect (95% CI) | P value |
|---|---|---|---|---|
| LVESV (mL) | −8.9 (32.7) | −18.8 (51.0) | 4.82 (−13.28 to 22.93) | 0.594 |
| Indexed LVESV (mL/m2) | −4.5 (16.7) | −10.5 (26.2) | 2.49 (−6.30 to 11.28) | 0.571 |
| LVEDV (mL) | −7.7 (40.5) | −24 (55.9) | 7.83 (−15.05 to 30.70) | 0.495 |
| Indexed LVEDV (mL/m2) | −4.3 (19.8) | −13.4 (29.0) | 3.9 (−7.05 to 14.85) | 0.478 |
| LVEF (%) | 2.6 (6.7) | 1.4 (9.6) | 0.69 (−3.32 to 4.69) | 0.732 |
| LVMI (g/m2) | 4.0 (11.1) | 0.6 (11.7) | 2.5 (−3.95 to 8.95) | 0.44 |
| LV stroke volume (mL) | 0.0 (6.5) | −2.9 (6.2) | 1.86 (−1.52 to 5.24) | 0.273 |
| Indexed LA volume (mL/m2) | −1.7 (13.5) | −1.5 (15.0) | −2.6 (−9.67 to 4.48) | 0.464 |
| Weight (kg) | −1.4 (4.4) | 0.15 (6.0) | −1.36 (−4.14 to 1.42) | 0.329 |
| Weight† (kg) | −1.9 (4.0) | 0.73 (5.3) | −2.26 (−4.83 to 0.31) | 0.083 |
| Systolic BP (mmHg) | −2.6 (18.9) | 3.6 (18.7) | −4.7 (−14.51 to 5.11) | 0.34 |
| Diastolic BP (mmHg) | −0.4 (7.4) | 8.8 (11.9) | −8.15 (−13.02 to −3.28) | 0.001 |
| Heart rate (beats/min) | −4.6 (10.8) | −1.3 (11.1) | −2.26 (−7.88 to 3.36) | 0.424 |
| Hemoglobin (g/dL) | 1.1 (1.1) | 0.0 (1.4) | 0.86 (0.27 to 1.46) | 0.005 |
| Hematocrit (%) | 4.0 (3.0) | 0.0 (4.0) | 2.89 (1.14 to 4.64) | 0.002 |
| HbA1c (mmol/mol) | −4.0 (10.4) | −1.2 (11.6) | −1.49 (−6.95 to 3.97) | 0.586 |
| BHB (mmol/L) | 0.03 (0.06) | 0 (0.06) | 0.04 (0.01 to 0.07) | 0.022 |
| Serum creatinine (μmol/L) | 5.3 (12.8) | 4.6 (12.1) | 1.46 (−5.56 to 8.47) | 0.679 |
| eGFR | −1.2 (12.0) | −5.3 (13.1) | 1.96 (−4.78 to 8.70) | 0.563 |
| Loop diuretic dose‡ (mg) | −16.0 (18.1) | 12.3 (28.3) | −29.06 (−42.17 to −15.95) | <0.001 |
BHB, β-hydroxy butyrate; LA, left atrial.
†
Analysis excludes large outliers; one patient from each arm because of excessive weight gain and loss (dapagliflozin n = 27, placebo n = 27).
‡
Bumetanide dose converted to equivalent frusemide dose (1 mg bumetanide = 40 mg frusemide).