Table 3.
Variable | Intention-to-treat analysis |
Per-protocol analysis |
||||||
---|---|---|---|---|---|---|---|---|
Dapagliflozin | Placebo | Differencea | P-Value | Dapagliflozin | Placebo | Differencea | P-Value | |
(n = 32) | (n = 34) | (95% CI) | (n = 29) | (n = 33) | (95% CI) | |||
Primary endpoint | ||||||||
Absolute LVM (g) | −3.95 ± 4.85 | −1.13 ± 4.55 | −2.82 (−5.13 to −0.51) | 0.018 | −4.36 ± 4.92 | −1.17 ± 4.43 | −3.2 (−5.62 to −0.77) | 0.011 |
Secondary endpoints | ||||||||
LVMI BSA (g/m2) | −0.58 ± 2.29 | −0.38 ± 1.79 | −0.20 (−1.21 to 0.80) | 0.691 | −0.64 ± 2.40 | −0.39 ± 1.81 | −0.25 (−1.32 to 0.82) | 0.644 |
LVMI Height (g/m) | −2.33 ± 2.87 | −0.71 ± 2.68 | −1.62 (−2.99 to −0.26) | 0.021 | −2.57 ± 2.91 | −0.73 ± 2.72 | −1.84 (−3.27 to −0.41) | 0.013 |
LVMI Height1.7 (g/m1.7) | −1.61 ± 2.00 | −0.51 ± 1.87 | −1.09 (−2.05 to −0.15) | 0.024 | −1.78 ± 2.03 | −0.52 ± 1.89 | −1.25 (−2.25 to −0.25) | 0.015 |
LVMI Height2.7 (g/m2.7) | −0.95 ± 1.20 | −0.32 ± 1.12 | −0.63 (−1.21 to −0.06) | 0.031 | −1.05 ± 1.22 | −0.33 ± 1.14 | −0.72 (−1.32 to−0.12) | 0.020 |
EF (%) | 1.45 ± 4.08 | 0.66 ± 3.76 | 0.79 (−1.14 to 2.72) | 0.415 | 1.60 ± 4.26 | 0.68 ± 3.81 | 0.92 (−1.13 to 2.97) | 0.372 |
EDV (mLs) | −0.15 ± 11.59 | 1.44 ± 10.62 | −1.59 (−7.06 to 3.87) | 0.562 | −0.17 ± 12.20 | 1.48 ± 10.78 | −1.65 (−7.49 to 4.18) | 0.573 |
ESV (mLs) | −1.86 ± 4.83 | −0.74 ± 4.81 | −1.12 (−3.50 to 1.25) | 0.348 | −2.05 ± 5.04 | −0.76 ± 4.89 | −1.29 (−3.82 to 1.23) | 0.310 |
SV (mLs) | 1.71 ± 11.18 | 2.18 ± 10.45 | −0.47 (−5.79 to 4.85) | 0.860 | 1.88 ± 11.75 | 2.24 ± 10.60 | −0.36 (−6.04 to 5.32) | 0.900 |
Left atrial area (Cm2)b | −0.25 ± 3.38 | 0.00 ± 3.5 | −1.20 (−2.82 to 0.42) | 0.143 | −0.5 ± 3.75 | 0.0 ± 3.5 | −1.29 (−3.01 to 0.44) | 0.088 |
P-values in bold indicate <0.05.
BSA, body surface area; EDV, end-diastolic volume; EF, ejection fraction; ESV; end-systolic volume; LVM, left ventricular mass; LVMI, left ventricular mass index; SV, stroke volume.
Absolute mean difference between groups. All values expressed in mean ± SD unless stated.
Median ± IQR.