Table 5.
| Study | EMPEROR-reduced (N = 3730) | EMPEROR-preserved (N = 5988) | DAPA-HF (N = 4744) | SOLOIST-WHF (N = 1222) | DELIVER (N = 6263) |
|---|---|---|---|---|---|
| Agent | Empagliflozin | Empagliflozin | Dapagliflozin | Sotagliflozin | Dapagliflozin |
| Diabetes related criteria | T2D or non-T2D (50% with T2D) | T2D or non-T2D (49% with T2D) | T2D or non-T2D (45% with T2D) | T2D | T2D or non-T2D (∼45% with T2D) |
| Study population | LVEF ≤40% NYHA class II–IV HF eGFR ≥20 ml/min/1.73 m2 |
LVEF >40% NYHA class II–IV HF Elevated NT-proBNP level 50% with eGFR < 60 ml/min/1.73 m2 |
LVEF ≤40% NYHA class II–IV HF eGFR ≥30 ml/min/1.73 m2 |
Recent hospitalization for HF with IV diuretics eGFR > 30 ml/min/1.73m2 |
LVEF >40% Evidence of structural heart disease Elevated BNP eGFR 61 ±19 ml/min/1.73 m2 |
| Cardiovascular outcome(s) (no difference between diabetic and nondiabetic) |
Primary outcome Reduction in the composite of CV death or hospitalization for HF: HR: 0.75 (CI: 0.65–0.86) Reduction in hospitalization for HF: HR: 0.70 (CI: 0.58–0.85) |
Primary outcome Reduction in the composite of CV death or hospitalization for HF: HR 0.79 (CI: 0.69–0.90) Reduction in hospitalization for HF: HR: 0.71 (CI: 0.60–0.83) Reduction of CV death: HR: 0.91 (CI: 0.76–1.09) |
Primary outcome Improvement in the composite of worsening HF or death from CV causes. HR: 0.74 (CI: 0.65–0.85) |
Primary outcome Reduction in CV deaths and hospitalization and ED visits for HF: HR 0.67 (CI: 0.52–0.85) Secondary outcome Reduction in hospitalizations and urgent visits: HR 0.64 (CI: 0.49–0.83) |
Primary outcome Reduction in the composite of CV death and HF events (hospitalizations and urgent HF visits: HF: HR: 0.82 (CI: 0.73–0.92) Secondary outcome (s) HF events: HR 0.79 (CI: 0.69–0.91) CV death: HR 0.88 (CI: 0.74–1.05) |
| Kidney outcome(s) | Secondary outcome Decrease in the rate of decline in eGFR over the course of the study. Between-group difference of 1.73 ml/min/1.73 m2 (95% CI: 1.10–2.37) |
Secondary outcome Decrease in the rate of decline in eGFR over the course of the study: 1.25 ml/min/1.73 m2 per year in empagliflozin vs. 2.62 ml/min/1.73 m2 per year in placebo group |
Secondary outcome No significant benefit in worsening kidney function. |
Secondary outcome No significant mean change in eGFR |
Safety outcome No difference in any kidney serious adverse event or adverse event that led to discontinuation of dapagliflozin or placebo (2.3 % vs. 2.5 % in dapagliflozin and placebo groups respectively) |
AF, atrial fibrillation; CI, confidence interval; CV, cardiovascular; eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; HR, hazard ratio; HF, heart failure; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; NT-proBNP, N-terminal–pro hormone B-type natriuretic peptide; SCr, serum creatinine; SOLOSIST- WHF, Sotagliflozin in Patients With Diabetes and Recent Worsening Heart Failure; T2D, type 2 diabetes; UACR, urinary albumin-to-creatinine ratio.