1. Medicines
  2. Cardio-Metabolic
  3. ENTRESTO® (sacubitril/valsartan)
  4. Clinical evidence: efficacy and safety
  5. PARADIGM-HF

Prescribing information

 

PARADIGM-HF

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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

Infographic showing relative reductions in cardiovascular or first hospitalisation for heart failure, in cardiovascular death only, and for hospitalisation for heart failure only.

IN CV DEATH OR FIRST HOSPITALISATION FOR HF

Composite primary endpoint
Events: 914 (21.8%) vs. 1,117 (26.5%);
HR (95% CI): 0.80 (0.73–0.87); p=0.00000021,3

20% reduction in relative risk vs ACEi

IN CV DEATH

Co-primary endpoint
Events: 558 (13.3%) vs. 693 (16.5%);
HR (95% CI): 0.80 (0.71–0.89); p=0.000041,3

21% reduction in relative risk vs ACEi

IN FIRST HOSPITALISATION FOR HF

Co-primary endpoint
Events: 537 (12.8%) vs. 658 (15.6%);
HR (95% CI): 0.79 (0.71–0.89); p=0.000041,3

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

Paradigm-hf1  Pioneer-hf6  Transition7,8  Prove-hf9  Evaluate-hf10 

 

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.
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ENT20-C046c(1) July 2020.
Cardio-metabolic
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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