Table 2.
Effect of sacubitril/valsartan on clinical outcomes in patients with heart failure (HF)
| Reference | Comparator | Definition of clinical events | Population | Subgroup | No. | Rate of primary outcomes (%) |
p-value | HR (95% CI) | |
|---|---|---|---|---|---|---|---|---|---|
| Sacubitril/valsartan | Comparator | ||||||||
| PARADIGM-HF [12] | Enalapril | CV death, HF hospitalization | Chronic HFrEF, | All | 8,399 | 21.8 | 26.5 | <0.001 | 0.80 (0.73–0.87) |
| LVEF ≤ 40% | 30 < eGFR <60 | 3,061 | 27.0 | 33.0 | NA | 0.79 (0.69–0.90) | |||
| eGFR ≥ 60 | 5,338 | 19.0 | 23.0 | NA | 0.81 (0.73–0.91) | ||||
| PARAGON-HF [31] | Valsartan | CV death, HF hospitalization | Chronic HFpEF, | All | 4,796 | 37.1 | 42.2 | 0.06 | 0.87 (0.75–1.01) |
| LVEF ≥ 45% | 30 < eGFR < 60 | 2,341 | NA | NA | NA | 0.79 (0.66–0.95) | |||
| eGFR ≥ 60 | 2,454 | NA | NA | NA | 1.01 (0.80–1.27) | ||||
| PARALLAX [32] | Enalapril, valsartan, or placebo | HF death, HF hospitalization | Chronic HFpEF, | All | 2,572 | NA | NA | 0.034 | 0.64 (0.42–0.97) |
| LVEF > 40% | |||||||||
| PIONEER-HF [28] | Enalapril | HF hospitalization | ADHF, | All | 881 | 8.0 | 13.8 | NA | 0.56 (0.37-0.84) |
| LVEF ≤ 40% | |||||||||
ADHF, acute decompensated heart failure; CI, confidence interval; CV, cardiovascular; eGFR, estimated glomerular filtration rate (in mL/min/1.73 m2); HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; HR, hazard ratio; LVEF, left ventricular ejection fraction; NA, not available; PARADIGM-HF, Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure; PARAGON-HF, Prospective Comparison of ARNI with ARB Global Outcomes in HF with Preserved Ejection Fraction; PARALLAX, Angiotensin Receptor Neprilysin Inhibition Versus Individualized RAAS blockade; PIONEER-HF, Patients Stabilized from an Acute Heart Failure Episode.