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. 2019 Jun;33(3):315-322.
doi: 10.1007/s10557-019-06873-1.

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

Joanne Simpson  1 , L Benson  2 , P S Jhund  3 , U Dahlström  4   5 , J J V McMurray  3 , L H Lund  6
Affiliations

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

Joanne Simpson et al. Cardiovasc Drugs Ther. 2019 Jun.

Abstract

Purpose: PARADIGM-HF demonstrated the superiority of sacubitril/valsartan over enalapril in patients with heart failure and reduced ejection fraction (HF-REF). How widely applicable sacubitril/valsartan treatment is in unselected patients with HF-REF is not known. We examined eligibility of patients with HF-REF for treatment with sacubitril/valsartan, according to the criteria used in PARADIGM-HF, in the Swedish Heart Failure Registry (SwedeHF).

Methods: Patients were considered potentially eligible if they were not hospitalized, had symptoms (NYHA class II-IV) and a reduced LVEF (≤ 40%), and were prescribed an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a dose equivalent to enalapril ≥ 10 mg daily. In these patients, we evaluated further eligibility according to the main additional PARADIGM-HF inclusion criteria.

Results: Of 12,866 outpatients in NYHA functional class II-IV with an LVEF ≤ 40%, 9577 were prescribed at least 10 mg of enalapril (or equivalent) daily. Complete additional data were available for 3099 of these patients (32.4%) and of them 75.5% were potentially eligible for treatment with sacubitril/valsartan. The most common reason for ineligibility was a low natriuretic peptide level (n = 462, 14.9%). Only a small proportion of patients were ineligible due to low eGFR or serum potassium level. Because only 78% of patients were taking ≥ 10 mg enalapril or equivalent daily, only 58.9% of all patients (75.5% of 78%) were eligible for sacubitril/valsartan.

Conclusions: Between 34 and 76% of symptomatic patients with HF-REF in a 'real world' population are eligible for treatment with sacubitril/valsartan, depending on background ACEI/ARB dose. The most common reason for ineligibility is a low natriuretic peptide level.

Keywords: Eligibility; Heart failure; PARADIGM-HF; Real-world population; Sacubitril-valsartan.

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Conflict of interest statement

Professor McMurray’s employer, University of Glasgow, was paid by Novartis for Professor McMurray’s time spent as co-principal investigator of the PARADIGM-HF trial. Professor Lund’s institution has received money for consulting fees from Novartis. Dr. Jhund and Professor Dahlström received honoraria from Novartis. J Simpson and L Benson have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Different eligibility scenarios tested
See this image and copyright information in PMC

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