INTERVENTION AND COMPARATOR | OUTCOMES | ||||
---|---|---|---|---|---|
STUDY | POPULATION | PRIMARY | SECONDARY | SAFETY | |
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 |
| Hyperkalemia: 8% vs 3.7% (P < .001), NNH = 24 over 1.8 y |
PARADIGM-HF (2014)13 | N = 8399 Key inclusion criteria
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 |
| Symptomatic hypotension: 14% vs 9.2% (P < .001), NNH = 21 over 2.3 y |
DAPA-HF (2019)14 | N = 4744 Key inclusion criteria
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 |
| NS |
EMPEROR-Reduced (2020)15 | N = 3730 Key inclusion criteria
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 |
| Genital infections: 1.7% vs 0.6% (P = .005), NNH = 91 over 1.3 y |
ACEI—angiotensin-converting enzyme inhibitor, ARB—angiotensin receptor blocker, ARNI—angiotensin receptor–neprilysin inhibitor, CV—cardiovascular, DAPA-HF—Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure, eGFR—estimated glomerular filtration rate, EMPHASIS-HF—Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure, EMPEROR-Reduced—Empagliflozin Outcome Trial in Patients with Chronic Heart Failure and a Reduced Ejection Fraction, HF—heart failure, HFH—heart failure hospitalization, HFrEF—heart failure with reduced ejection fraction, HR—hazard ratio, LVEF—left ventricular ejection fraction, MRA—mineralocorticoid receptor antagonist, NNH—number needed to harm, NNT—number needed to treat, NS—not significant, NT-proBNP— N-terminal pro–brain natriuretic peptide, NYHA—New York Heart Association, PARADIGM-HF—Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure, SBP—systolic blood pressure.