Study | Year | Diabetes | EMPA | Age Mean (SD) | Female sex (%) | Placebo | Age Mean (SD) | Female sex (%) | Duration | LVEF | Cardivascular outcomes | AEs or SAEs |
---|---|---|---|---|---|---|---|---|---|---|---|---|
de Boer RA, et al. RCT [19] | 2019 | 100.0% | N = 30 10-25 mg once daily | 68.5(3.0) | 33.3% | N = 33 | 71.0 (3.75) | 42.4% | 12 weeks | NA | 1) Blood pressure (BP), including SBP and DBP; 2) NT-proBNP; 3) Cardiac parameters; 4) NYHA class. | Yes |
Packer M, et al.(EMPEROR-Reduced), RCT [20] | 2020 | NA | N = 1863 10 mg once daily | 67.2 (10.8) | 23.5% | N = 1867 | 66.5 (11.2) | 24.4% | 16 months | ≤ 40% | 1) Cardiovascular worsening (including CV death and hospitalization for HF); 2) NT-proBNP; 3) Systolic BP; 4) Change in quality-of-life score on KCCQ. | Yes |
Nassif ME, et al. (EMBRACE-HF), RCT [21] | 2020 | 52.0% | N = 33 10 mg once daily | 69.5(12.0) | 36.4% | N = 32 | 62.9 (13.3) | 37.5% | 12 weeks | >40% (mean 44%) | 1) Change in PA diastolic pressure from baseline to end of treatment; 2) KCCQ; 3) NT-proBNP; 4) 6-min walking distance (6MWD); 5) Systolic BP. | NR |
Anker SD, et al. (EMPEROR-Preserved), RCT [22] | 2021 | NA | N = 2997 10 mg once daily | 71.8 (9.3) | 44.6% | N = 2991 | 71.9 (9.6) | 44.7% | 26.2 months | > 40% | 1) Cardiovascular worsening (including CV death and hospitalization for HF); 2) NT-proBNP; 3) Change in quality-of-life score on KCCQ. | Yes |
Omar M, et al. (Empire HF), RCT [23] | 2021 | 12.6% | N = 95 10 mg once daily | 65.0 (10.0) | 17.0% | N = 95 | 63.0 (12.0) | 13.0% | 12 weeks | ≤ 40% | Cardiac parameters: 1) Left ventricular end-systolic and end-diastolic volume indexes (LVESV and LVEDV); 2) Left atrial volume index (LAVi); 3) LVEF (adjusted for age, sex, type 2 diabetes, and atrial fibrillation); 4) Changes in LVMI; 5) Global longitudinal strain; 6) Relative wall thickness; 7) PCWP; 8) Cardiac index. | NR |
Lee MMY, et al. (SUGAR-DM-HF), RCT [11] | 2021 | 100.0% | N = 52 10 mg once daily | 68.2 (11.7) | 34.6% | N = 53 | 69.2(10.6) | 18.9% | 36 weeks | ≤ 40% | Cardiac parameters : 1) Change in LV end-systolic volume index (LVESVi); 2) LV end-diastolic volume index (LVEDVi); 3) LV global longitudinal strain; 4) LVEF; 5) KCCQ-TSS 6) 6MWD 7) NT-proBNP | NA |
Abraham WT, et al. (EMPERIAL-Reduced), RCT [24] | 2021 | 59.9% | N = 156 10 mg once daily | 69.0 (3.63) | 22.4% | N = 156 | 70.0 (3.63) | 28.8% | 12 weeks | ≤ 40% | 1) 6MWD; 2) KCCQ-TSS; 3) CHQ-SAS dyspnea score; 4) NT-proBNP. | Yes |
Abraham WT, et al. (EMPERIAL-Preserved). RCT [24] | 2021 | 40.6% | N = 157 10 mg once daily | 74.0 (2.75) | 44.6% | N = 158 | 75.0 (6.5) | 41.8% | 12 weeks | > 40% | 1) 6MWD; 2) KCCQ-TSS; 3) CHQ-SAS dyspnea score; 4) NT-proBNP. | Yes |
Santos-Gallego CG, et al. RCT [12] | 2021 | 0.0% | N = 84 10 mg once daily | 64.2(10.9) | 36.0% | N = 84 | 59.9(13.1) | 35.7% | 6 months | ≤ 40% | Cardiac parameters: 1) LV end-systolic and -diastolic volume (LVESV and LVEDV); 2) LV mass; 3) LVEF; 4) 6MWD; 5) KCCQ. | Yes |
Pietschner R, et al. RCT [25] | 2021 | 24.5% | N = 36 | 69.0 (8.1) | 19.4% | N = 17 | 67.4(8.7) | 5.9% | 12 weeks | 38.8% (8.6%) | 1) BP 2) 24-hour ambulatory BP | NA |
Filippatos G, et al. RCT* [27] | 2022 | 100.0% | N = 1466 | NR | NR | N = 1472 | NA | NA | 52 weeks | NA | 1) KCCQ-TSS; 2) CHQ-SAS dyspnea score; 3) NT-proBNP. 4) BP | Yes |
Filippatos G, et al. RCT* [27] | 2022 | 0.0% | N = 1531 | NR | NR | N = 1472 | NA | NA | 52 weeks | NA | 1) KCCQ-TSS; 2) CHQ-SAS dyspnea score; 3) NT-proBNP. 4) BP | Yes |