Prescribing information

 

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Icon for PIONEER-HF study

Prescribe Entresto for your patients in hospital to see early benefits1

 

 

PIONEER-HF was a clinical trial designed to assess the change in NT-proBNP as well as safety and tolerability of inpatient initiation of Entresto for chronic HFrEF compared with ACEi (enalapril) in haemodynamically stabilised patients following ADHF. It was a prospective, multicentre, double-blind, randomised, 8-week study (N=881).1

 

Patients must have been haemodynamically stabilised before randomisation, defined as1:

   SBP ≥100 mmHg for the prior 6 h; no symptomatic hypotension

   No increase in IV diuretics in prior 6 h

   No IV vasodilators in prior 6 h

   No IV inotropes in prior 24 h

 

PIONEER-HF: Entresto demonstrated comparable safety and tolerability to ACEi (enalapril)1

 Table showing adverse events in the PIONEER-HF study

**The rates of worsening renal function, hyperkalaemia, symptomatic hypotension and angioedema did not differ significantly between the two groups. Adverse events that take longer to transpire may not have appeared in this study.1,3

Worsening renal function was defined by an increase in the serum creatinine concentration of 0.5 mg/dl or more (≥44 μmol/l) and a decrease in the estimated glomerular filtration rate of 25% or more.1

††The rate of permanent discontinuations due to an AE did not differ significantly between the two treatment groups.1,3

 

Icon for PIONEER-HF and TRANSITION studies

In-hospital initiation: efficacy, feasibility and safety1,3

 

 

Watch Dr Patricia Campbell, at the British Society for Heart Failure Autumn Meeting 2019, discuss the PIONEER-HF and TRANSITION studies and share practical tips to initiate Entresto in haemodynamically stable, hospitalised patients.

 

Read the PIONEER-HF clinical summary

Read the TRANSITION clinical summary

 

There’s a wealth of data supporting the use of Entresto in your chronic HFrEF patients1-8

Graphic showing Clinical evidence: PARADIGM-HF, PIONEER-HF, TRANSITION, PROVE-HF, EVALUATE-HF         

 

Indication: Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.8

Entresto is not indicated for the treatment of acute HF. Patients in the PIONEER-HF and TRANSITION trials were required to be haemodynamically stabilised from an ADHF while in hospital.1,3

ACEi, angiotensin converting enzyme inhibitor; ADHF, acute decompensated heart failure; AE, adverse event; ARR, absolute risk reduction; CI, confidence interval; HFrEF, heart failure with reduced ejection fraction; HR, hazard ratio; IV, intravenous; NT-proBNP, N-terminal pro-B-type natriuretic peptide.

References

  1. Velazquez EJ et al. N Engl J Med 2019; 380:539–548 plus supplementary info.
  2. Morrow DA et al. Circulation 2019; 139:2285–2288.
  3. Wachter R et al. Eur J Heart Fail 2019; 21:998–1007.
  4. McMurray JJV et al. N Engl J Med 2014; 371:993–1004.
  5. Pascual-Figal D et al. ESC Heart Fail 2018; 5:327–336.
  6. Januzzi JL Jr et al. JAMA 2019; 322:1085–1095.
  7. Desai AS et al. JAMA 2019; 322:1077–1084.
  8. Entresto Summary of Product Characteristics, 2020. 
ENT20-C046d(1) July 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]