EMPHASIS-HF (2011)12 | N = 2737 Key inclusion criteria Key exclusion criteria | 50 mg/d of eplerenone vs placebo | CV death or HFH: 18.3% vs 25.9%, HR = 0.63 (95% CI 0.54 to 0.74), NNT = 14 over 1.8 y | CV death: 10.8% vs 13.5%, HR = 0.76 (95% CI 0.61 to 0.94), NNT = 38 over 1.8 y HFH: 12% vs 18.4%, HR = 0.58 (95% CI 0.47 to 0.70), NNT = 16 over 1.8 y All-cause death: 12.5% vs 15.5%, HR = 0.76 (95% CI 0.62 to 0.93), NNT = 14 over 1.8 y
| Hyperkalemia: 8% vs 3.7% (P < .001), NNH = 24 over 1.8 y |
PARADIGM-HF (2014)13 | N = 8399 Key inclusion criteriaClinically stable HFrEF patients (70% NYHA class II) Elevated natriuretic peptide level (eg, NT-proBNP > 400 ng/L if HFH in the past 12 mo) Taking a stable dose of ACEI or ARB (equivalent to enalapril ≥ 10 mg/d) and β-blocker Use of an MRA was encouraged (56%)
Key exclusion criteria | 97 mg–103 mg of sacubitril-valsartan twice daily vs 10 mg of enalapril twice daily | CV death or HFH: 21.8% vs 26.5%, HR = 0.8 (95% CI 0.73 to 0.87), NNT = 22 over 2.3 y | CV death: 13.3% vs 16.5%, HR = 0.8 (95% CI 0.71 to 0.89), NNT = 32 over 2.3 y HFH: 12.8% vs 15.6%, HR = 0.79 (95% CI 0.71 to 0.89), NNT = 36 over 2.3 y All-cause death: 17% vs 19.8%, HR = 0.84 (95% CI 0.76 to 0.93), NNT = 36 over 2.3 y
| Symptomatic hypotension: 14% vs 9.2% (P < .001), NNH = 21 over 2.3 y |
DAPA-HF (2019)14 | N = 4744 Key inclusion criteriaClinically stable HFrEF (68% NYHA class II) Elevated natriuretic peptide level (eg, NT-proBNP ≥ 400 ng/L if HFH in the past 12 mo) Taking standard HFrEF therapy (94.4% ACEI, ARB or ARNI; 96% β-blocker; 71% MRA) 45% had type 2 diabetes at baseline
Key exclusion criteria | 10 mg/d of dapagliflozin vs placebo | CV death or worsening HF (HFH or an urgent visit resulting in intravenous HF therapy): 16.3% vs 21.2%, HR = 0.74 (95% CI 0.65 to 0.85), NNT = 21 over 1.5 y | CV death: 9.6% vs 11.5%, HR = 0.82 (95% CI 0.69 to 0.98), NNT = 53 over 1.5 y HFH: 9.7% vs 13.4%, HR = 0.7 (95% CI 0.59 to 0.83), NNT = 28 over 1.5 y
| NS |
EMPEROR-Reduced (2020)15 | N = 3730 Key inclusion criteriaClinically stable HFrEF (75% NYHA class II) Elevated natriuretic peptide level Taking standard HFrEF therapy (89% ACEI, ARB, or ARNI; 95% β-blocker; 71% MRA) 50% had type 2 diabetes at baseline
Key exclusion criteria | 10 mg/d of empagliflozin vs placebo | CV death or HFH: 19.4% vs 24.7%, HR = 0.75 (95% CI 0.65 to 0.86), NNT = 19 over 1.3 y | CV death: 10.0% vs 10.8%, HR = 0.92 (95% CI 0.75 to 1.12), NS HFH: 13.2% vs 18.3%, HR = 0.69 (95% CI 0.59 to 0.81), NNT = 20 over 1.3 y
| Genital infections: 1.7% vs 0.6% (P = .005), NNH = 91 over 1.3 y |