Prescribing information

 

   

Start with ENTRESTO® to see benefits and keep patients out of the hospital longer vs ACEi (enalapril)1–7

Start with ENTRESTO in your newly diagnosed chronic HFrEF patients1–5
 

Proven benefits of ENTRESTO in newly diagnosed HFrEF patients1–5

  • Consistent NT-proBNP reductions and reverse cardiac remodelling2,5
  • Safety and tolerability comparable to ACEi (enalapril)4
  • Supported as first-line treatment by CareMe UK and the 2021 ACC ECDP Update6,7
2 award stickers; 1: CaReMe UK partnership; 2; American college of cardiology (ACC) consensus 2021
 
 

Across multiple trials, ENTRESTO was extensively studied in newly diagnosed chronic HFrEF patients1–5
 

pie chart 1: 34% Pioneer-HF n= 303/881
pie chart 2: 29% transition n= 286/991
pie chart 3: 10% prove-HF n= 78/794

 

 

Watch our on-demand webinar: Early initiation of ENTRESTO (sacubitril/valsartan): alter the cycle of re-admission in patients with heart failure2

 
 

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In newly diagnosed patients, ENTRESTO as first choice reduces cardiac stress and improves outcomes vs ACEi1,2
 

Bar graph showing in newly diagnosed patients, Entresto as first choice reduces cardiac stress and improves outcomes vs ACEi. Entresto (n=134) −73.6%. Enalapril (n=154) −56.2%
 
Line graph representing Pioneer-HF (n=303): cumulative incidence of CV death or HF rehospitalisation. Entresto (n=141). Enalapril (n=162)
 

ENTRESTO is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction. ENTRESTO is not indicated for the treatment of acute HF.10 Patients in the PIONEER-HF/TRANSITION trial were required to be haemodynamically stabilised from an ADHF episode while in hospital.1,3

ENTRESTO as first choice keeps patients out of the hospital longer vs ACEi (enalapril)1,6,7

Regardless of where patients are in their journey, starting ENTRESTO as early as possible improves outcomes vs ACEi (enalapril).1,6,7
 

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Start with ENTRESTO to maximise near and long-term benefits for your patients1,6,7

 

 

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Starting ENTRESTO now reduces HF hospitalisations, saving hospital budgets and alleviating system burden13

 

ENTRESTO is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction. ENTRESTO is not indicated for the treatment of acute HF.10 Patients in the PIONEER-HF/TRANSITION trial were required to be haemodynamically stabilised from an ADHF episode while in hospital.1,3

 

Watch our on-demand webinar: What can I do to keep my chronic HFrEF patients out of hospital?

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Start ENTRESTO now to help patients stay out of the hospital and live longer vs ACEi (enalapril)10
 

PARADIGM-HF (N=8,442): Lower risk of CV death or HF hospitalisation with ENTRESTO vs ACEi10
 

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In a post hoc analysis, ENTRESTO reduced the relative risk of sudden cardiac death by 20% vs enalapril (P=0.0082)10

Discover the benefits of ENTRESTO vs ACEi (enalapril) in improving your chronic HFrEF patient’s treatment experience11,12

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ENTRESTO is indicated in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction.10

Please click here for safety information

* PIONEER-HF was a prospective, multicentre, double-blind, randomised controlled trial designed to assess the safety, tolerability, and efficacy of in-hospital initiation of ENTRESTO compared with enalapril in 881 adult patients in the United States with HFrEF (EF ≤40% and NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL) stabilised during hospitalisation for ADHF. The primary endpoint was time-averaged proportional change in NT-proBNP from baseline through Weeks 4 and 8. An exploratory clinical end point was the outcome of a composite of serious clinical events, which included death, rehospitalisation for heart failure, implantation of a left ventricular assist device, and inclusion on the list of patients eligible for heart transplantation.1
† TRANSITION was a randomised, parallel, open-label study comparing pre-discharge vs post-discharge (within 1–14 days) initiation of ENTRESTO in patients with HFrEF (NYHA Class II-IV HF, LVEF ≤40%) following haemodynamic stabilisation after an episode of ADHF.3 A post hoc analysis of the TRANSITION trial comprised hospitalised patients divided into subgroups based on HF history: newly diagnosed HFrEF, or chronic HFrEF diagnosed prior to enrolment in the study. Newly diagnosed was defined as patients who were not known to have HFrEF and/or symptoms or signs of HF prior to hospitalisation and whose index admission was the first presentation of HF. The definition of newly diagnosed HF was irrespective of prior treatment status, including the use of ACEi/ARBs.4
‡ PROVE-HF is a phase IV, single-arm, multicentre, open-label trial in the United States, of which 654 (82.4%) patients completed the 52-week study. This open-label study evaluated the effects of ENTRESTO on biomarkers, cardiac remodelling, and patient-reported outcomes in heart failure with reduced left ventricular ejection fraction. The correlation between the change in concentration of NT-proBNP and E/e′ was added to the statistical analysis plan prior to the database lock.5
§ PIONEER-HF Trial Open-label Extension: In PIONEER-HF, 8 weeks after randomisation, patients continued in a 4-week, open-label study with all patients receiving ENTRESTO.6
¶ Serious clinical outcomes include HF hospitalisation or CV death.

ACC, American College of Cardiology; ACEi, angiotensin-converting enzyme inhibitor; ADHF, acute decompensated heart failure; ARB, angiotensin receptor blocker; ARNI, angiotensin receptor neprilysin inhibitor; ARR, absolute risk reduction; BNP, brain natriuretic peptide; CaReMe UK, Cardio-Renal-Metabolic Partnership UK; CI, confidence interval; CV, cardiovascular; ECDP, Expert Consensus Decision Pathway; E/e’, ratio of early mitral inflow velocity to mitral annular early diastolic velocity; EF, ejection fraction; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HR, hazard ratio; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal-pro-brain natriuretic peptide; NYHA, New York Heart Association; RRR, relative risk reduction.

References:

  1. Velazquez EJ, et al. N Engl J Med 2019;380(6):539–548.
  2. Ambrosy AP, et al. J Am Coll Cardiol 2020;76(9):1034–1048.
  3. Wachter R, et al. Eur J Heart Fail 2019;21(8):998–1007.
  4. Senni M, et al. Eur J Heart Fail 2019;22(2):303–312.
  5. Januzzi JL Jr, et al. JAMA 2019;322(11):1085–1095.
  6. DeVore AD, et al. Initiation of angiotensin-neprilysin inhibition after acute decompensated heart failure: results of the openlabel extension of the PIONEER-HF trial. Data presented at American College of Cardiology 68th Annual Scientific Session, March 2019.
  7. Morrow DA, et al. Circulation 2019;139(19):2285–2288.
  8. CaReMe HF algorithm. Available at: https://www.britishcardiovascularsociety.org/__data/assets/powerpoint_do.... (Accessed September 2021).
  9. Maddox TM, et al. J Am Coll Cardiol 2021;77:772–810.
  10. ENTRESTO Summary of Product Characteristics. Electronic medicines compendium website, UK. Available at: https://www.medicines.org.uk/emc/product/7751/smpc. (Accessed September 2021).
  11. Chandra A, et al. JAMA Cardiol 2018;3(6):498–505.
  12. Lewis EF, et al. Circ Heart Fail 2017;10(8):e003430.
  13. Gaziano TA, et al. JAMA Cardiol 2020;5(11):1236–1244.
  14. McMurray JJ, et al. N Engl J Med 2014;371:993–1004.
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UK | October 2021 | 145893
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