Table 2. Changes in Efficacy Measures in the Intention-to-Treat Population.
| Variable | Empagliflozin, 10 mg/d | Placebo | Adjusted treatment effect (95% CI)a | P value | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. | Baseline value | No. | 12-wk Value | Change | No. | Baseline value | No. | 12-wk Value | Change | |||
| Primary efficacy measures, mean (SD) | ||||||||||||
| LVESVI, mL/m2b | 89 | 54 (30) | 89 | 49 (23) | −4.1 (13.1) | 90 | 49 (22) | 87 | 48 (21) | 0.1 (14.7) | −4.3 (−8.5 to −0.1) | .04 |
| LVESV, mL | 89 | 112 (66) | 89 | 100 (50) | −8.5 (26.4) | 90 | 104 (48) | 87 | 102 (44) | 0.2 (31.2) | −8.8 (−17.5 to −0.2) | .046 |
| LVEDVI, mL/m2 | 89 | 81 (36) | 89 | 75 (26) | −4.2 (15.2) | 90 | 75 (27) | 87 | 76 (26) | 1.3 (18.6) | −5.5 (−10.6 to −0.4) | .03 |
| LVEDV, mL | 89 | 167 (79) | 89 | 154 (57) | −8.9 (30.4) | 90 | 159 (60) | 87 | 160 (57) | 2.8 (39.5) | −11.8 (−22.4 to −1.2) | .03 |
| LAVI, ml/m2 | 90 | 41 (20) | 92 | 40 (17) | −1.1 (7.9) | 92 | 36 (13) | 86 | 37 (13) | 1.4 (8.3) | −2.5 (−4.8 to −0.1) | .04 |
| In nonatrial fibrillation | 60 | 36 (17) | 59 | 34 (14) | −1.2 (6.9) | 61 | 32 (8) | 59 | 33 (8) | 0.9 (6.6) | NA | NA |
| In atrial fibrillation | 32 | 51 (21) | 33 | 51 (18) | −0.8 (9.6) | 29 | 45 (17) | 27 | 46 (17) | 2.6 (11.3) | NA | NA |
| Ejection fraction, % | 89 | 35 (9) | 89 | 37 (11) | 2.4 (7.5) | 90 | 36 (9) | 86 | 38 (9) | 1.0 (8.3) | 1.2 (−1.2 to 3.6) | .32 |
| Secondary efficacy measures, mean (SD) | ||||||||||||
| LVMI, g/m2a,b | 95 | 130 (64) | 94 | 122 (50) | −3.7 (28.0) | 95 | 128 (46) | 90 | 131 (40) | 5.1 (28.2) | −9.0 (−17.2 to −0.8) | .03 |
| Global longitudinal strain, % | 89 | −11 (4) | 88 | −11 (4) | −0.1 (2.3) | 88 | −11 (3) | 87 | −12 (3) | −0.4 (2.3) | 0.4 (−0.3 to 1.0) | .31 |
| RWT, % | 95 | 0.32 (0.12) | 94 | 0.33 (0.13) | 0.01 (0.09) | 95 | 0.32 (0.13) | 90 | 0.32 (0.13) | 0.01 (0.10) | 0.001 (−0.03 to 0.03) | .97 |
| Blood pressure, mm Hg | ||||||||||||
| Systolic | 95 | 119 (18) | 94 | 115 (14) | −4.4 (14.8) | 95 | 121 (16) | 92 | 121 (14) | 0.2 (12.8) | −4.6 (−8.5 to −0.6) | .02 |
| Diastolic | 95 | 72 (11) | 94 | 71 (10) | −1.0 (10.1) | 95 | 74 (12) | 92 | 27 (11) | −1.3 (9.2) | 0.3 (−2.5 to 3.0) | .84 |
| Hematocrit, % | 95 | 42 (4) | 94 | 44 (4) | 2.1 (2.4) | 95 | 41 (4) | 94 | 41 (4) | −0.1 (2.3) | 2.1 (1.5 to 2.8) | <.001 |
| Weight, kg | 95 | 91 (17) | 94 | 89 (16) | −1.2 (1.8) | 95 | 94 (18) | 92 | 94 (18) | 0.2 (2.6) | −1.3 (−2.0 to −0.7) | <.001 |
Abbreviation: LAVI, left atrial volume index; LVEDVI, left ventricular end-diastolic volume index; LVESVI, left ventricular end-systolic volume index; LVMI, left ventricular mass index; NA, not applicable; RWT, relative wall thickness.
a
Intention-to-treat population, adjusted for age, sex, type 2 diabetes, and atrial fibrillation.
b
Indexed to body surface area.