The 2022 AHA/ACC/HFSA Heart Failure Guideline recognizes ENTRESTO® in 3 heart failure patient populations1†
Patients with HF with LVEF ≤60% may be appropriate for ENTRESTO2
This equates to approximately 80% of patients with HF2
Patients with HF with LVEF ≤60% may be appropriate for ENTRESTO2
This equates to approximately 80% of patients with HF2
†In the 2022 HF Guideline, ENTRESTO is recommended as a first-line treatment and to replace well-tolerated ACEi/ARB in patients with NYHA Class II–III HFrEF (Class 1 recommendation). ENTRESTO was also included as a treatment option for HFmrEF (LVEF 41%–49%) and select patients with HFpEF (LVEF ≥50%), particularly for patients with LVEF on the lower end of the spectrum (Class 2b recommendation).
‡NYHA Class II–III patients with HFrEF.
§In NYHA Class II–III HFrEF in patients who tolerate ACEi/ARB.
In the 2022 HF Guideline, ENTRESTO is recommended as a first-line treatment and to replace well-tolerated ACEi/ARB in patients with NYHA Class II–III HFrEF (Class 1 recommendation).
ENTRESTO is the ONLY BRANDED HEART FAILURE MEDICATION deemed by the 2022 Heart Failure Guideline to provide HIGH ECONOMIC VALUE1‖ | |
In patients with chronic symptomatic HFrEF, treatment with ENTRESTO instead of an ACEi provides HIGH ECONOMIC VALUE | |
Multiple analyses found ENTRESTO to be HIGH ECONOMIC VALUE compared to an ACEi in the outpatient setting | |
Inpatient initiation of ENTRESTO was seen as HIGH ECONOMIC VALUE compared with delayed initiation post-discharge | |
‖Value statements for select therapies were created based upon benchmarks adopted by AHA/ACC/HFSA where high-quality cost-effectiveness studies of the intervention had been published. |
The 2022 Heart Failure Guideline expands its recognition of ENTRESTO to select HFmrEF patients1
The 2022 Heart Failure Guideline expands its recognition of ENTRESTO to select HFpEF patients1
¶PARAGON-HF was a randomized, double-blind, active-controlled trial comparing ENTRESTO to valsartan in 4796 adult patients with symptomatic (NYHA Class II–IV) HFpEF ≥45%, elevated levels of natriuretic peptides, and structural heart disease. After completing the run-in period with valsartan followed by ENTRESTO, patients entered the double-blind period and were randomly assigned (1:1) to ENTRESTO 97/103 mg BID (n=2407) or valsartan 160 mg BID (n=2389). The median follow-up duration was 35 months, and patients were treated for up to 4.7 years. At the primary end point, reduction in the composite of total (first and recurrent) HF hospitalizations and CV death, ENTRESTO did not achieve statistical significance vs valsartan (RR 0.87; 95% CI: 0.75–1.01; P=.06).2
*In PARAGON-HF, defined as LVEF ≥45% with structural heart disease (LAE or LVH); median LVEF was 57%. LVEF is a variable measure and the normal range can vary.2
BOXED WARNING: FETAL TOXICITY
ENTRESTO is contraindicated in patients with hypersensitivity to any component...
ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
LVEF is a variable measure, so use clinical judgment in deciding whom to treat.
Definitions
ACC, American College of Cardiology; ACEi, angiotensin-converting enzyme inhibitor; AHA, American Heart Association; ARB, angiotensin II receptor blocker; BID, twice daily; CI, confidence interval; HFmrEF, heart failure with mildly reduced ejection fraction; HFSA, Heart Failure Society of America; LAE, left atrial enlargement; LVH, left ventricular hypertrophy; NYHA, New York Heart Association; RASi, renin-angiotensin system inhibitor; RR, relative rate.
References
1. Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022;79(17):e263-e421. doi:10.1016/j.jacc.2021.12.012
2. ENTRESTO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.