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ENTRESTO® has a proven safety profile comparable to an ACEi and an ARB1

PARADIGM-HF: ENTRESTO has safety comparable to enalapril in patients with HFrEF
Adverse reactions reported in ≥5% of patients treated with ENTRESTO in the double-blind period†
Adverse Reactions Graph

†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, the safety of ENTRESTO was comparable to valsartan.

*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

Important Safety Information

BOXED WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue ENTRESTO as soon as possible
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus

ENTRESTO is contraindicated in patients with hypersensitivity to any component...

Indication

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.

Click or scroll to see IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND INDICATION

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.