†Due to the run-in period, adverse event rates were lower than would be expected in practice.
No new safety signals were observed in patients with HFpEF* with LVEF below normal1 |
*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.1
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
ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin II receptor blocker; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; LAE, left atrial enlargement; LVH, left ventricular hypertrophy.
References
1. ENTRESTO [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp.
2. Fonarow GC, Stough WG, Abraham WT, et al. Characteristics, treatments, and outcomes of patients with preserved systolic function hospitalized for heart failure: a report from the OPTIMIZE-HF Registry. J Am Coll Cardiol. 2007;50(8):768-777.
3. Ibrahim NE, Song Y, Cannon CP, et al. Heart failure with mid-range ejection fraction: characterization of patients from the PINNACLE Registry®. ESC Heart Fail. 2019;6(4):784-792.
4. Virani SS, Alonso A, Aparicio HJ, et al; on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2021 update: a report from the American Heart Association. Circulation. 2021;143:e1-e490.