ENTRESTO® demonstrated the following results vs. ACEi enalapril1,4,6,7
Component of
primary endpoint
Primary endpoint
Component of
primary endpoint
Secondary endpoints
Clinically relevant and statistically significant superiority to enalapril was shown for combined CV death or first HF hospitalization in patients with HF with reduced ejection fraction1,4
20% reduced risk of composite CV death or first HF hospitalization‡ was
demonstrated with ENTRESTO® vs. enalapril
(HR: 0.80 [95% CI: 0.73-0.87]; 1-sided p=0.0000002; primary endpoint) 1
914 (21.8%) vs. 1,117 (26.5%) events
Time to first occurrence of CV death or HF
hospitalizations in
PARADIGM-HF
In PARADIGM-HF, risk reduction with ENTRESTO®
(composite
of first HF
hospitalization or CV death)
was consistent across subgroups, including:1,4
- Age
- Gender
- Race
- Geography
- Ejection fraction
- Renal function
- History of hypertension
- History of diabetes
- Presence of atrial fibrillation
The PARADIGM-HF trial was a multinational, randomized, double-blind trial comparing ENTRESTO® (sacubitril/valsartan) to enalapril in 8,442 adult patients with HFrEF. Patients were randomized to receive either ENTRESTO® 200 mg (97.2 mg sacubitril and 102.8 valsartan; N=4,209) twice daily or enalapril 10 mg twice daily (N=4,233) in addition to recommended therapy. The primary endpoint was the first event in the composite of CV death or hospitalization for HF.
† Comparative clinical significance is unknown. ‡ The primary endpoint was defined as the time-to-first-event. § CV death includes all patients who died up to the cut-off date irrespective of previous hospitalization. ¶ Two-sided p-value for Total HF hospitalizations, all other p-values one-sided as pre-specified. ACEi: angiotensin-converting-enzyme inhibitor; CV: cardiovascular; HF: heart failure; RR: risk reduction.