Contact us
Speak to a Novartis representative.
Image
Image
ENTRESTO® (sacubitril/valsartan) guidelines
In Ireland, ENTRESTO is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF).1
Consider prescribing ENTRESTO as recommended by the following international heart failure (HF) guidelines:2,3
2021/2023 ESC Guidelines (Europe)
ARNi may be used first line as part of cornerstone HFrEF therapy with a BB, MRA and SGLT2i in the 2021 ESC Guidelines for the treatment of chronic HFrEF patients2
2022 ACC/AHA/HFSA Guidelines (US)
In patients with chronic symptomatic HFrEF NYHA class II or III who tolerate an ACEi or ARB, replacement by an ARNi is recommended to further reduce morbidity and mortality.3
ENTRESTO can help eligible patients with improvements in social and physical activities as well as provide 3x greater improvement in HRQoL (as measured by KCCQ overall summary score) vs enalapril.*
*LSM estimation (SE) ENTRESTO vs enalapril: 0.80 (SE 0.20) vs −0.39 (SE −0.20). LSM estimates (SE) difference: 1.19 [0.28], p<0.001. Overall score comprising KCCQ measurement differences at pre-determined study KCCQ questionnaire administrations study timepoints of: Months 4, 8, 12, 24 & 36 (from randomisation).
Image
‡ENTRESTO (vs imputed placebo).4
Comparisons between drug classes should not be drawn.
This is a decision analytical model study applied on the total US eligible HF population (N=2.1 m). The magnitude of mortality reduction for SGLT2i was determined from the DAPA-HF trial.4
Treatment should not be initiated if the serum potassium level is >5.4 mmol/L.1
Monitoring of serum potassium is recommended, especially in patients who have risk factors such as renal impairment, diabetes mellitus or hypoaldosteronism or who are on a high-potassium diet or on mineralocorticoid antagonists. If patients experience clinically significant hyperkalaemia, adjustment of concomitant medicinal products, or temporary down-titration or discontinuation is recommended. If serum potassium level is >5.4 mmol/L discontinuation should be considered. Use of ENTRESTO may be associated with an increased risk of hyperkalaemia, although hypokalaemia may also occur.1
See clinical data supporting the recommendation of ENTRESTO in symptomatic chronic HFrEF patients
ENTRESTO should not be co-administered with another ARB and is contraindicated with an ACEi due to increased risk for angioedema. Allow for a 36-hour washout when switching from an ACEi1
Summary of the safety profile
The most commonly reported adverse reactions in adults during treatment with ENTRESTO were hypotension (17 .6%), hyperkalaemia (11.6%) and renal impairment (10.1 %). Angioedema was reported in patients treated with ENTRESTO (0.5%).1
Very common AEs: Hyperkalaemia, hypotension, renal impairment.1
Common AEs: Anaemia, hypokalaemia, hypoglycaemia, dizziness, headache, syncope, vertigo, orthostatic hypotension, cough, diarrhoea, nausea, gastritis, renal failure (renal failure, acute renal failure), fatigue, asthenia.1
†Analysis of 2,132,800 patients with HFrEF and NYHA class II-IV heart failure.4
ACC, American College of Cardiology; ACEi, angiotensin-converting enzyme inhibitor; AE, adverse event; AHA, American Heart Association; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor neprilysin inhibitor; BB, beta blocker; ESC, European Society of Cardiology; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HRQoL, health-related quality of life; KCCQ, Kansas City cardiomyopathy questionnaire; LSM, least squares mean; LVEF, left ventricular ejection fraction; MRA, mineralocorticoid receptor antagonist; NYHA, New York Heart Association; RAASi, renin-angiotensin-aldosterone system inhibitor; RR, risk reduction; SBP, systolic blood pressure; SE, standard error; SGLT2i, sodium-glucose co-transporter-2 inhibitor.
References
ENTRESTO® (sacubitril/valsartan) Summary of Product Characteristics. Available on www.medicines.ie.
McDonagh TE, et al. Eur Heart J 2021;42(36):3599–3726.
Heidenreich PA, et al. Circulation 2022;145(18):e895–e1032.
Bassi NS, et al. JAMA Cardiol 2020;5(8):948–951.
IE11607085 | April 2026
