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Published on: January 16, 2019

"Real World" Eligibility for Sacubitril/Valsartan in Unselected Heart Failure Patients: Data from the Swedish Heart

Joanne Simpson1, L Benson2, P S Jhund3

  • 1British Heart Foundation Glasgow, Institute of Cardiovascular and Medical Sciences, University of Glasgow, University Avenue, Glasgow, G12 8TA, UK. joannesimpson1@nhs.net.

Cardiovascular Drugs and Therapy
|March 24, 2019
PubMed

Insights

Sacubitril/valsartan is effective for heart failure with reduced ejection fraction (HF-REF). Eligibility in real-world HF-REF patients varies, with low natriuretic peptide levels being a common exclusion factor.

Area of Science:

  • Cardiology
  • Pharmacology

Background:

  • Sacubitril/valsartan demonstrated superiority over enalapril in the PARADIGM-HF trial for heart failure with reduced ejection fraction (HF-REF).
  • The applicability of sacubitril/valsartan in unselected, real-world HF-REF patient populations remains unclear.

Purpose of the Study:

  • To assess the eligibility of HF-REF patients in the Swedish Heart Failure Registry (SwedeHF) for sacubitril/valsartan treatment, using PARADIGM-HF trial criteria.
  • To identify factors influencing eligibility for sacubitril/valsartan in a broad HF-REF population.

Main Methods:

  • Patients in the Swedish Heart Failure Registry with LVEF ≤40% and NYHA class II-IV were evaluated.
  • Initial eligibility required treatment with an ACEI or ARB at enalapril equivalent ≥10 mg/day.
  • Further eligibility was assessed based on PARADIGM-HF inclusion criteria, including natriuretic peptide levels, eGFR, and serum potassium.

Main Results:

  • Of 12,866 outpatients, 9577 met initial criteria (NYHA II-IV, LVEF ≤40%, ACEI/ARB dose).
  • Among 3099 with complete data, 75.5% were potentially eligible.
  • The most common reasons for ineligibility were low natriuretic peptide levels (14.9%), with few excluded for low eGFR or high potassium.
  • Overall eligibility, considering ACEI/ARB dosing, was 58.9% of all patients.

Conclusions:

  • Real-world eligibility for sacubitril/valsartan in symptomatic HF-REF patients ranges from 34% to 76%, influenced by background ACEI/ARB dose.
  • Low natriuretic peptide levels are the primary barrier to sacubitril/valsartan eligibility in this population.
Abstract

Keywords:
EligibilityHeart failurePARADIGM-HFReal-world populationSacubitril-valsartan

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