PARADIGM-HF

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

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=0.0000002^1,3

IN CV DEATH

Co-primary endpoint
Events: 558 (13.3%) vs. 693 (16.5%);
HR (95% CI): 0.80 (0.71–0.89); p=0.00004^1,3

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=0.00004^1,3

The clear benefit of Entresto vs. ACEi (enalapril) led to its fast-track approval^4,5

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

*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 patients^1–3,6–10

Paradigm-hf¹  Pioneer-hf⁶  Transition^7,8  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.