Table 2.
Outcomes of the Patients in the 2 Groups
| Luseogliflozin (n=83) | Voglibose (n=82) | P Value | |
|---|---|---|---|
| Primary outcome, % (95% CI) | |||
| Change in ratio of BNP | |||
| After 4 wk from baseline | −15.48 (−25.32 to −4.33) | −0.13 (−11.56 to 12.78) | 0.108 |
| After 12 wk from baseline | −9.0 (−20.0 to 3.4) | −1.94 (−12.3 to 9.6) | 0.26 |
| After 24 wk from baseline | −13.99 (−26.65 to 0.85) | 0.31 (−12.80 to 15.38) | 0.133 |
| Main secondary efficacy outcomes, % (95% CI) | |||
| Change in E/e′ | 5.20 (−5.83 to 16.24) | 1.32 (−5.82 to 8.47) | 0.85 |
| Change in left ventricular ejection fraction | 2.78 (−2.66 to 8.21) | 2.95 (−1.38 to 7.30) | 0.62 |
| Change in body weight | −0.84 (−2.54 to 0.85) | −0.57 (−1.98 to 0.85) | 0.67 |
| Change in hemoglobin A1c | −1.87 (−3.31 to −0.44) | −1.19 (−3.18 to −0.81) | 0.71 |
| Safety outcomes | n=84 | n=82 | |
| Major adverse cardiovascular outcome | 0 | 0 | |
| Hypoglycemic adverse events | 0 | 1 (1.2) | 0.49 |
| Urinary tract infection | 0 | 1 (1.2) | 0.49 |
| Any infection | 1 (1.2) | 1 (1.2) | 1.0 |
| Severe hypotension | 1 (1.2) | 0 | 1.0 |
| Elevation of blood pressure | 2 (2.3) | 0 | 0.50 |
| Gastrointestinal symptoms | 0 | 6 (7.3) | 0.013 |
| Bone fracture | 0 | 1 (1.2) | 0.49 |
| Fatigue | 1 (1.2) | 2 (2.4) | 0.62 |
| Thirst | 1 (1.2) | 0 | 1.0 |
| Exploratory hemodynamic and biomarker outcomes, % (95% CI) | |||
| Change in systolic blood pressure | −3.96 (−6.89 to −1.03) | 0.54 (−2.23 to 3.32) | 0.036 |
| Change in heart rate | 0.49 (−3.48 to 4.45) | 2.62 (−1.56 to 6.80) | 0.39 |
| Change in estimated GFR | −4.26 (−7.20 to −1.32) | −0.83 (−3.35 to 1.69) | 0.061 |
| Change in NT‐pro‐BNP | −8.43 (−19.84 to 4.60) | −5.50 (−15.17 to 5.27) | 0.56 |
| Change in high‐sensitivity CRP | 22.47 (−1.65 to 52.52) | 9.97 (−18.13 to 47.71) | 0.55 |
| Change in E/A | 3.42 (−2.48 to 9.33) | 6.95 (−1.78 to 15.7) | 0.57 |
| Change in e′ | 1.22 (−9.08 to 11.5) | 2.46 (−6.26 to 11.2) | 0.82 |
| Change in left atrial diameter | 2.37 (−1.23 to 5.96) | −1.34 (−5.17 to 2.49) | 0.105 |
| Change in left atrial volume index | −4.49 (−14.6 to 5.62) | −0.62 (−11.8 to 10.6) | 0.51 |
| Change in left ventricular mass index | −4.23 (−11.9 to 3.41) | 2.29 (−3.66 to 8.24) | 0.31 |
Data are presented as 95% CIs or n (%). BNP indicates B‐type natriuretic peptide; CRP, C‐reactive protein; E/A, ratio of early to atrial mitral inflow velocity; E/e′, ratio of early mitral inflow velocity to mitral annular early diastolic velocity; GFR, glomerular filtration rate; and NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide.