Prescribing information

 

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Icon for PARADIGM-HF study

Entresto is the only treatment with proven superior efficacy to ACEi (enalapril) in chronic HFrEF patients1

 

PARADIGM-HF was a superiority trial designed to compare the long-term efficacy and safety of Entresto vs. ACEi (enalapril) in patients with symptomatic chronic HFrEF. It was a randomised, double-blind, parallel group, active-controlled, event-driven trial with a median follow-up of 27 months (N=8,442).1,2

The clear benefit of Entresto vs. ACEi (enalapril) led to its fast-track approval4,5

PARADIGM-HF: Entresto demonstrated comparable safety and tolerability vs. ACEi (enalapril)1,3

Table showing adverse events in the PARADIGM-HF study

*While more patients experienced symptomatic hypotension with Entresto than with ACEi (enalapril), there was no increase in the rate of discontinuation due to hypotension-related effects (0.9% vs. 0.7%; p=0.38).1

 

PARADIGM-HF – the largest ever randomised trial in HF1

Dr Simon Williams provides an overview of PARADIGM-HF, the largest HF trial ever conducted, and outlines the subsequent approvals for Entresto.

 

Read the PARADIGM-HF study paper

There’s a wealth of data supporting the use of Entresto in your chronic HFrEF patients1–3,6-10

         

 

Indication: Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction.3

ACEi, angiotensin converting enzyme inhibitor; ARR, absolute risk reduction; CI, confidence interval; rate; CV, cardiovascular; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HR, hazard ratio.

References

  1. McMurray JJV et al. N Engl J Med 2014; 371:993–1004.
  2. McMurray JJV et al. Eur J Heart Fail 2013; 15:1062–1073.
  3. Entresto Summary of Product Characteristics, 2020.
  4. NICE, 2018. Chronic heart failure in adults: diagnosis and management [NG106]. Available at: https://www.nice.org.uk/guidance/ng106/evidence/full-guideline-pdf-65388... (Accessed January 2020).
  5. MHRA Decision: Early Access to Medicines Scheme (EAMS) scientific opinion: sacubitril/valsartan.
  6. Velazquez EJ et al. N Engl J Med 2019; 380:539–548.
  7. Wachter R et al. Eur J Heart Fail 2019; 21:998–1007.
  8. Pascual-Figal D et al. ESC Heart Fail 2018; 5:327–336.
  9. Januzzi JL Jr et al. JAMA 2019; 322:1085–1095.
  10. Desai AS et al. JAMA 2019; 322:1077–1084.
ENT20-C046c June 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 patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]