ENTRESTO (sacubitril/valsartan), a neutral endopeptidase inhibitor in combination with an angiotensin II receptor blocker (ARB)

CARDIOLOGY - New medicinal product
Opinions on drugs - Posted on Dec 21 2017

Reason for request

Inclusion

Minor improvement in patients with class II or III heart failure with LVEF ≤ 35%, remaining symptomatic despite treatment with ACE inhibitor or sartan and requiring a change in treatment.

 

  • ENTRESTO has Marketing Authorisation in adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
  • A modest efficacy was demonstrated versus enalapril 20 mg/day on a composite endpoint of cardiovascular death and hospitalisation for heart failure, in patients with class II or III heart failure according to the NYHA classification with left ventricular ejection fraction (LVEF) ≤ 35% and previously treated and stabilized by ACE inhibitor or sartan.
  • The adverse effects of ENTRESTO are hypotension, hyperkalemia and impaired renal function.

Clinical Benefit

Substantial

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Clinical Added Value

minor

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Therapeutic use

-

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