Table 1 Baseline characteristics of the study population
Empagliflozin 10 mg (n = 44) | Placebo (n = 46) | |
|---|---|---|
Age, years* | 64 (57, 69) | 64 (56, 72) |
Body mass index, kg/m2* | 26.7 (24.5, 30.2) | 26.6 (24.4, 29.3) |
Body surface area, m2* | 2.0 (1.8, 2.1) | 1.9 (1.8, 2.1) |
Male sex | 90 | 96 |
Smoking history | 41 | 46 |
Duration of type 2 diabetes, years* | 10.0 (4.0, 15.0) | 10.0 (5.0, 15.0) |
Hypertension | 92 | 90 |
History of myocardial infarction | 39 | 44 |
History of percutaneous coronary intervention > 2 months before screening | 53 | 40 |
History of coronary artery bypass surgery > 2 months before screening | 57 | 56 |
History of heart failure | 4.0 | 8.0 |
History of peripheral artery disease | 4.0 | 6.0 |
History of transient ischemic attack or stroke | 16 | 13 |
Serum creatinine, mg/dL* | 0.9 (0.8, 1.0) | 0.9 (0.8, 1.0) |
Hemoglobin A1c, %* | 7.9 (7.5, 8.4) | 7.9 (7.3, 8.7) |
Hematocrit, %* | 0.42 (0.40, 0.46) | 0.42 (0.39, 0.44) |
Systolic blood pressure, mmHg* | 128 (120, 143) | 134 (125, 146) |
Diastolic blood pressure, mmHg* | 74 (69, 82) | 77 (71, 81) |
Heart rate, bpm* | 67 (60, 77) | 68 (60, 76) |
Cardiac MRI data | ||
Left ventricular mass, g | 116.5 (26.3) | 120.9 (33.0) |
Left ventricular mass index, g/m2 | 59.3 (10.9) | 62.2 (12.8) |
Left ventricular end diastolic volume index, mL/m2 | 63.3 (15.5) | 71.4 (15.4) |
Left ventricular end systolic volume index. mL/m2 | 27.1 (10.5) | 32.3 (11.8) |
Left ventricular ejection fraction. % | 58.0 (7.5) | 55.5 (8.7) |
Echocardiographic data | ||
Right ventricular systolic pressure, mmHg† | 22.8 (6.5) | 20.7 (4.4) |
Peak tricuspid regurgitation velocity, m/s† | 2.2 (0.38) | 2.1 (0.27) |
Tricuspid annular plane systolic excursion, cm | 2.0 (1.2) | 1.8 (0.5) |
Right ventricular S’, mm | 10.4 (2.7) | 10.9 (2.9) |
Biomarkers | ||
NT-pro B-type natriuretic peptide, pg/mL* | 97.0 (46.0, 190) | 116 (59.0, 230) |
High sensitivity troponin I, ng/mL* | 0.03 (0.03, 0.20) | 0.03 (0.03, 0.03) |
Medications at baseline | ||
Aspirin/P2Y12 inhibitor | 82 | 85 |
Beta blocker | 78 | 81 |
Calcium channel blocker | 12 | 31 |
Angiotensin converting enzyme inhibitor/angiotensin receptor blocker | 82 | 85 |
Statin | 96 | 96 |
Insulin | 25 | 25 |
Metformin | 96 | 92 |